CTRP Registration Users Guide

1. NCI CTRP Registration User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 CTRP Registration Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 Getting Started with Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1 Application Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.2 About Registration and Clinical Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.3 Typical Life Cycle of a Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.4 Role-Based Tasks in Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.5 Creating a CTRP Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.5.1 Browser Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.6 Using the Toolbar in Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.7 Requesting Organization Admin Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.8 Managing Registration Email Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.9 Getting Help in Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.10 Changing the Color Scheme in Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2 Searching for Trial, Organization, and Person Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1 Searching for Trial Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1.1 Types of Trials Included in Trial Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1.2 Columns in Registered Trial Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1.3 Columns in Draft Trial Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1.4 Viewing Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.1.5 Exporting Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.2 Searching for Organization Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2.3 Searching for Person Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3 Submitting Clinical Trial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1 Registering New Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.1 About Trial Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.2 Registering New Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.3 Registering Abbreviated (Industrial and Other) Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.4 Printing Trial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.5 Editing Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.1.6 Completing and Deleting Saved Drafts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2 Amending Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2.1 Amendment Process Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2.2 Amendment Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2.3 Examples of Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2.4 Amending Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.2.5 Reviewing and Submitting Trial Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3 Updating Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.1 Trial Attributes You Can Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.2 Examples of Protocol Document Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.3 Updating Trial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.4 Updating Trial Statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.5 Updating Trial Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.6 Updating Participating Site Statuses in Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3.3.7 Reviewing and Submitting Trial Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4 Adding Your Site to Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4.1 Using the Add My Site Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4.2 Viewing Participating Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4.3 Updating Participating Site Organization Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5 Registration Site Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.1 Granting and Revoking Administrative Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2 Assigning and Unassigning Accrual Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2.1 Assigning and Unassigning Accrual Access by Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2.2 Assigning and Unassigning Accrual Access by Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2.3 Assigning and Unassigning Accrual Access by Organization Family . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2.4 Viewing Accrual Assignment History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.2.5 Viewing Accrual Assignment History by Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.3 Managing Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.3.1 About Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.3.2 Trial Ownership Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.3.3 Assigning Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.3.4 Displaying Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.4 Adding Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.5 Managing Data Table 4 Information for Your Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.5.1 Managing Targeted Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.5.2 Managing Program Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.5.3 Specifying the Center Principal Investigator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5.5.4 Managing Local Trial IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.6 Verifying Trial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.6.1 How to Access the Trial Data Verification Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.6.2 How to Verify Trial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7 Working With Persons and Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7.1 Looking up Registered Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7.2 Requesting Creation of an Organization Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7.3 Looking Up Registered Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.7.4 Requesting Creation of a Person Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.8 Viewing Trial Summary Reports and XML Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.9 Managing Your Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.9.1 Changing Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.1.9.2 Resetting Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.9.3 Managing Your User Account Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.10 Viewing Trial-Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.11 Working with Tables and Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.11.1 Filtering Registration Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 CTRP Registration Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1 CTRP Trial Categories, Study Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2 Data Table 4 Anatomic Site Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.3 Expanded Access Statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.4 Funding Mechanism Code Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.5 NCI Division and Program Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.6 NIH Grant Institute Code Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.7 NIH Institution Code Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.8 Primary Purpose Value Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.9 Status Rules for Trial Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.10 Status Transition Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.11 Trial Phase Value Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.12 Trial Processing Statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.13 Trial Status Values in the CTRP and ClinicalTrials.gov . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14 Trial Summary Report and XML File Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.1 TSR-XML Data Element Comparisons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2 Trial Summary Report Data Elements by Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.1 Trial Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.2 General Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.3 Status/Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.4 Regulatory Information/Oversight Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.5 Human Subject Safety/Regulatory Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.6 IND/IDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.7 NIH Grants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.8 Data Table 4 Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.9 Collaborators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.10 Disease/Condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.11 Trial Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.12 Eligibility Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.13 Intervention(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.14 Arm/Group(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.15 Primary and Secondary Outcome Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.16 Sub-groups Stratification Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.17 Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.2.18 Participating Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.14.3 Excerpts from Example TSR and Example XML File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.15 Trial Types and Subtypes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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NCI CTRP Registration User Guide
Contents of this Page

About this Guide
Audience

CTRP Registration Links

NCI Clinical Trials Reporting
Program Registration
Templates for batch accrual
submissions, and other resources

CTRP Resources

CTRP Website
Dictionary of cancer terms
Terminology resources

You can print and export wiki pages
You can send this page to a printer or convert it to a PDF, HTML, or Word document. See Printing and Exporting Wiki Pages.

Application Support
If you have problems with the program or have suggestions for any of the CTRP User's Guides, contact the NCI Clinical Trials Reporting Office using
the information and guidelines provided in Application Support.

About this Guide
This guide provides an overview of NCI Clinical Trials Reporting Program (CTRP) Registration and instructions for using its tools and resources to submit
new clinical trials and amend and/or update those currently registered and verified in the CTRP. Additionally it contains instructions for searching for and
viewing details of existing registered clinical trials.
In the following panel, you can search within or browse the page tree for this guide:

Audience
This guide is designed for members of the NCI clinical research community, who, in their roles as submitters and/or principal investigators, register details
about clinical trials for use by the broader scientific community. Separate instructions are provided for Site Administrators.

3

CTRP Registration Tasks
This page tree provides instructions on performing tasks in CTRP Registration. In the following panel, you can search within or browse the page tree:

Opening
Linked
Pages
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en
the
top
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thi
s
tab
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top
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4

Getting Started with Registration
This page tree introduces you to NCI Clinical Trials Reporting Program (CTRP) Registration, and provides instructions for registering for an account.
For browser information, refer to Browser Support.

5

Application Support
If you are experiencing technical issues with the CTRP web application, or if you have questions, contact us at [email protected]. When submitting
support requests, include:
Your contact information, including your telephone number
The name of the application/tool you are using
The relevant URL
A description of the problem and steps to recreate it
The text of any error messages you have received
For other CTRP topics, contact the Clinical Trials Reporting Office (CTRO) at [email protected].

6

About Registration and Clinical Trial Details
Registration provides cancer clinical trial access to researchers who have CTRP accounts. It enables these users to register, amend, and update trials one
at a time, and to view details of existing trials submitted by members of the cancer research community. You can register Complete and Abbreviated interve
ntional and non-interventional trials. (For the definition of Complete and Abbreviated, refer to CTRP Trial Categories, Study Sources.)
Registration captures clinical trial details, a sanctioned set of key data elements. This set of recorded data enables the research community to share and
analyze standardized clinical trial details.
The glossary on the CTRP web site at http://www.cancer.gov/aboutnci/organization/ccct/ctrp/glossary provides definitions, attributes, and
examples of metadata associated with trials. You can access other CTRP resources from the same page.
As a CTRP account holder, you can search for and review a subset of registered data that has been submitted to CTRP and validated by the Clinical Trials
Reporting Office (CTRO).

7

Typical Life Cycle of a Trial
This section describes, in words and visually, the typical life cycle of a trial:
1. The submitter submits the trial. The trial has a processing status of Submitted.
2. The CTRO Document Specialist performs validation on the Submitted trial:
a. If the trial is not complete, the specialist sends a request to the submitter for information. The trial has a processing status of On Hold.
When the CTRO receives the requested information, a Document Specialist takes the trial off hold. The trial's processing status returns
to the previous status, which in this case would be Submitted.
b. If the trial is not valid, the specialist rejects the submission. The trial has a processing status of Rejected.
c. If the trial is complete and valid, the specialist accepts the submission. The trial has a processing status of Accepted.
3. One or more CTRO Document Specialists perform abstraction on the Accepted trial, including administrative processing, scientific processing,
and quality control. The trial has a processing status of Abstracted.
4. The system sends the Trial Summary Report (TSR) of the Abstracted trial to the submitter. The trial has a processing status of Verification
Pending.
5. The submitter verifies the abstraction as per the TSR, and returns feedback to the CTRO within five business days after receiving the TSR. (A
business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's list of
Federal Holidays.) The trial has a processing status of Abstraction Verified Response.
6. The CTRO Document Specialist decides, based on the feedback received, whether to restart administrative processing, scientific processing, or
both for the trial (step 3).
7. The CTRO Document Specialist completes the verification.
The following diagrams illustrate the typical life cycle of a trial and the relationship between actions and processing statuses:

8

For more information, refer to Trial Processing Statuses and Amendment Process Life Cycle.

9

Role-Based Tasks in Registration
Each person who registers for a CTRP account is associated with a role. One registered user from an organization can request an Administrator role from
the CTRO. That Administrator can grant administrative privileges to other users in the Administrator's organization.
CTRP account holders can perform only those tasks that are associated with their assigned roles.
The following table is a matrix of roles and tasks. A Yes or No in each table cell indicates whether someone with a given role can perform the task.
Tasks
Manage Accrual
Access

User
No

Site Administrator
Yes
A registered user logged in as the Lead Organization's Site Administrator for any trial other than DCP or
CTEP trials
Super Abstractor for DCP and CTEP trials

View Accrual
Assignment History

No

Yes
For trials associated with Administrator's organization or family member organization.

Display Trial
Ownership

No

Yes
For any trial associated with the Administrator's site for which the organization is the lead organization.

Manage Trial
Ownership

No

Yes

Manage
Participating Site
Record Ownership

No

Yes

Grant Administrative
Authority

No

For registered users who are affiliated with the Administrator's organization.
Yes
For registered users who are affiliated with the Administrator's organization.

Manage Program
Codes

No

Yes
For details, refer to Managing Program Codes.

Request
Administrative
Authority

Yes

Yes

Manage SystemGenerated Emails

Yes

Yes

Globally, for
user's own
account
(receive all
messages or
none)

The system sends emails (including TSRs) to Site Administrators automatically only if the site Administrator's
affiliated organization is the trial's lead organization, or if the Site Administrator is the trial submitter and/or trial
owner.
Site Administrators can manage their own email notification globally, and other users' notifications on a trial-bytrial basis.

Register Trials

Yes

Yes

Update/Amend Trials

Yes

Yes

Add/Update
Participating Site
Information

Yes

Yes

10

Creating a CTRP Account
Even if you already have an NIH (or NCI) account, you must register for an associated CTRP account. You can create an account using Registration's
account creation feature.
New users must have access to a valid email address to create an account.

A CTRP account identifies your organization affiliation, whether or not you own a particular trial record, and other such details.
How to Create a New CTRP Account
1. Navigate to the CTRP Registration home page at https://trials.nci.nih.gov/registration. For browser information, refer to Browser Support.
2. Click the Sign Up tab.
3. In the Email Address field, enter the email address you will use for registering trials (this should be your business email address), and then click
Next. The Sign Up tab displays the new account form, pre-populated with the email address you provided.
4. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates
a required field.
Privacy concerns
Contact information is required for internal administrative use only. Your information is not revealed to the public.

Field
Label

Description/Instructions

Contact
informa
tion*

Enter your contact information in the fields provided. Provide your professional information only. For countries other than the United
States, select None (International) in the State field, and enter None in the Zip Code field.

Organiz
ation
Affiliati
on*

Click Look Up and select the appropriate organization from the list of search results. To search for an organization, follow the
instructions in Looking up Registered Organizations. (If your trial’s affiliated organization is not listed, you can ask the CTRO to
create the organization record. To do so, follow the instructions in Requesting Creation of an Organization Record.)
Once organization affiliation is established, the system displays one of the following:
If no one in your organization has site administrative (Admin) access, the My Account page displays a check box
that enables you to request Admin privileges.
If at least one other person in your organization currently has a Site Admin role, the system displays the View
Admins link, which enables you to display the name(s) of the current Admin(s).

Reques
t for
Admin
Access

This check box is displayed if no one in your organization has site administrative (admin) access. Optionally, to request
administrative rights for your organization, select the check box. You will receive an email message from the CTRO once your
request has been approved or rejected.

PRS
Organiz
ation
Name

Type the full name of the organization as it appears in the ClinicalTrials.gov Protocol Registration System account list at http://prsinfo
.clinicaltrials.gov/prs_organizations.html.
Keep your account up to date
The PRS organization name is required for uploading trial records to ClinicalTrials.gov via a system-generated file. The
PRS organization name you include in your profile is included in that file. This precludes having to update the PRS name
in the file. Therefore it is very important for you to update your account whenever there is a change in PRS.

Receiv
e
Email
Notifica
tions

The CTRP system can automatically send you an email message whenever some aspect of a trial you have submitted or own has
changed. For example, the system would notify you when the CTRO has accepted a trial that you submitted. It would send another
message when the Trial Summary Report (TSR) is available for review. You can choose to receive all messages or none of them:
To receive all system messages, set Receive Email Notifications to Yes.
To opt out, set Receive Email Notifications to No.

5. Click the Sign Up button. The system sends you a message stating that you will receive an email notification with instructions for activating your
account.

11

Allow two business days for your account to be processed
It may take up to two business days to create your account. If you have any questions in the interim, contact us by sending an email to
[email protected].
(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel
Management's list of Federal Holidays.)

6. When the account information email message arrives, open it and click the embedded link to the My Account page.

12

Browser Support
We test on Firefox the CTRP web applications (Registration, Accrual, Protocol Abstraction, and Person and Organization Curation). For most modern
browsers (Internet Explorer, Chrome, Safari), CTRP should also work without issue. However, please note that it has been officially tested only on Firefox.
If you discover a browser-related issue, please contact us at [email protected]. Please include the following information:
Your browser name and version
Your operating system version
When possible, a screen shot illustrating the difficulty

13

Using the Toolbar in Registration
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
The toolbar runs across the top of each page and remains in place even if you scroll down the page. Menus on the toolbar provide access to sub-menus
whenever an arrow appears next to a menu name. Otherwise, clicking a menu item launches another web page.

Your name appears on the upper right corner of the page and the associated arrow provides access to the My Account page.
You can also sign out of the application from this sub-menu.

14

Requesting Organization Admin Rights
You can request Admin rights for your affiliated organization to take advantage of the following features:
Site administration - Accept or reject requests for Admin rights from other users within your organization
Trial ownership management - Assign and unassign ownership of trials associated with your organization to other registered users within your
organization
Accrual access - Assign and unassign access to Accrual to registered users within your organization
Program code management - Manage the set of program codes and program code assignments for your organization family. For details, refer
to Managing Program Codes.
Condition for Admin Requests
The Request for Admin Access check-box on the My Account page is displayed only if no one else in your organization is an administrator.
How to Request Admin Rights
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the top right corner of any page, click Your Username > My Account. The My Account page displays all of your Registration account
information.
4. Verify that you have indicated your current organization affiliation.
5. If you need to update your affiliated organization, click Look Up and select the appropriate organization from the list of search results. To search
for an organization, follow the instructions in Looking up Registered Organizations. (If your trial’s affiliated organization is not listed, you can ask
the CTRO to create the organization record. To do so, follow the instructions in Requesting Creation of an Organization Record.)
Once organization affiliation is established, the system displays one of the following:
If no one in your organization has site administrative (Admin) access, the My Account page displays a check box that enables
you to request Admin privileges.
If at least one other person in your organization currently has a Site Admin role, the system displays the View Admins link,
which enables you to display the name(s) of the current Admin(s).
6. Request Admin privileges as follows:
If the Request for Admin Access check box is available, select it. The system sends you an email message from the CTRO once your
request has been approved or rejected.
If the View Admins link is available, select it and examine the resulting information. Request administration authority from a current site
administrator.

15

Managing Registration Email Notifications
The CTRP system can automatically send you an email message whenever some aspect of a trial you have submitted or own has changed. For example,
the system would notify you when the CTRO has accepted a trial that you submitted. It would send another message when the Trial Summary Report
(TSR) is available for review. You can choose to receive all messages or none of them.
How to Manage Registration Email Messages
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the top right corner of any page, click Your Username > My Account. The My Account page displays all of your Registration account
information.
4. You have the following choices:
To receive all system messages, set Receive Email Notifications to Yes.
To opt out, set Receive Email Notifications to No.
5. Click Save.

16

Getting Help in Registration
Help is available on both a field and page level. More comprehensive information is available in this User's Guide.
A Help icon

is available beside most fields in which you enter trial data.

How to Display Instructions/Information for a Field
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. Hover your cursor over the Help icon
next to it.

Online Help provides instruction/information for the topic you are working on.
How to Launch Online Help
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. Below your name on the toolbar, click Help.

How to Return to this User's Guide
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the toolbar, click Quick Links > Registration User's Guide.

17

Changing the Color Scheme in Registration
You can choose a site-wide color scheme to suit your preferences.
How to Change the Color Scheme
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the top right corner of any page, click (User Name) > My Account.

4. Scroll to the bottom of the My Account window and select one of the five color schemes.

5. Click Save.

18

Searching for Trial, Organization, and Person Records
This page tree provides instructions for searching for trials, organizations, and persons currently registered with the CTRP. In each case you are presented
with a predefined set of search criteria that is appropriate for the type of search you are conducting.

19

Searching for Trial Records
You can retrieve existing trial records once you have registered for an account. For instructions, refer to Creating a CTRP Account.
After you have selected your search criteria, you can further limit or expand your search for trials as follows:
Use the Search All Trials feature to search for all trials registered with the CTRP from all organizations/accounts, whether or not you are the
submitter or owner.
Use the Search My Trials feature to search for trials that you own, whether or not your organization is listed as the lead organization or
participating site.
Use the Search Saved Drafts feature to search for trials that you have saved as drafts but have not submitted.
The search feature you choose determines which categories of trials will be returned, and the actions you can perform with those results, as shown in the
table below. For rules that determine which trial details are displayed, refer to Types of Trials Included in Trial Search Results.
Search Option

Search All Trials

Types of
Trials
Returned

All trials

Actions
Permitted

Search My Trials

Search Saved Drafts
Partial Submissions

Trials you own that are on hold
Trials you own, including those
conducted at an affiliated site.

View Trial Details
Add/Update My Site (Abbreviated trials only)
Verify Trials (for trials you submitted but may not own)

The results of this search may include a subset
of trials that you own or submitted.

View Trial Details
Update Trials
Amend Trials
Request TSR/XML
Change Status
Add/Update My Site (Abbreviated
trials only)
Verify Trials

View Trial Details
Complete Submissions
Add/Update My Site
(Abbreviated trials only)

All registered users can search trials with the "Accepted" and subsequent processing status. Additionally, you can search for trials that you own
that have not been validated. These trials are indicated by the "Submitted" status. See Trial Processing Statuses for information about statuses
that occur during the course of the trial processing workflow.
How to Search for Existing Trials
1. Click the Search Clinical Trials tab. Or, on the toolbar, click Search > Clinical Trials.
The Search Clinical Trials page appears.

2. Select or enter the appropriate information in the drop-down lists and text fields. (You do not have to select or enter any search criteria if you use
the Search My Trials feature. When searching All Trials, you must select or enter at least one search criterion.) The following table describes
the fields.

20

Tip
If you are searching for a saved draft, you can search by the following criteria only:
Title
Phase
Purpose
Identifier Type (NCT Exact Match, Lead Organization, or Other Identifier only)
Organization Type (Lead Organization only)
Organization
Principal Investigator
Because the system adds wildcards for you, do not enter wildcard symbols in the search fields.

Trial Search Criteria
Field
Title

Instructions/Description
To narrow the search by this trial attribute, specify one or more words from the official name of the protocol provided by the study
principal investigator or sponsor (as it appears in the protocol document).
Avoid specifying the entire title in the search field
Use keywords rather than phrases or the entire title. Doing so minimizes the potential for excluding from the search
results any titles with misspellings or slightly different phrasing.

Phase

To narrow the search by this trial attribute, specify the phase of investigation, as defined by the US FDA for trials involving
investigational new drugs. For valid values, refer to Trial Phase Value Definitions.

Pilot
Trial?

To narrow the search by this trial attribute, specify whether the trial is a pilot trial.
To find trials identified as pilot trials, select Yes.
To find trials identified as not pilot trials, select No.
To find trial records on which no pilot value has been specified, select None.

Purpose

To narrow the search by this trial attribute, specify the main reason for conducting the trial. For valid values, refer to Primary
Purpose Value Definitions.

Identifier
Type

To narrow the search by both identifier and the type of trial identifier, specify both. Valid identifier types are as follows:
NCI - The unique identifier assigned to the trial by the NIH National Cancer Institute.
NCT (Exact Match) - The unique identifier assigned to the trial by the ClinicalTrials.gov Protocol Registration System (PRS).
Provide the exact number, including the NCT prefix. Example: NCT00012345
Lead Organization - The unique identifier assigned to the trial by the lead organization.
Other identifier - Additional trial identifier such as unique identifier from other registries, NIH grant numbers, or protocol
numbers assigned by the Review Board.
The Identifier Type field is optional, even when specifying an identifier.

Identifier

To narrow the search by this trial attribute, specify the numeric or alphanumeric identifier assigned to the trial. For Inter-Group
trials, specify the Lead Group's trial number.

Organizat
ion Type

To narrow the search by both organization and organization type, specify both. Valid organization types are as follows:
Lead Organization - Returns all trials on which the selected organization is the Lead Organization
Participating Site - Returns all trials on which the selected organization is a Participating Site
Both - Returns all trials on which the selected organization is either the Lead Organization or Participating Site
You can change the Organization Type without affecting any other search criteria you may have selected
previously.

Organizat
ion

To narrow the search by this trial attribute, specify the initial letter(s) of the organization. The system suggests organizations as
you type. Select the organization from the list of suggestions.
To search for trials by organization without having to specify what role the organization plays in the trial, select Both
from the Organization Type list, and then select the name of the organization of interest.

21

Principal
Investigat
or

To narrow the search by this trial attribute, specify the

Search
by Trial
Category

To narrow the search by this trial attribute, specify the category of the trial, as determined by the submission of a full protocol
(Complete) or a ClinicalTrials.gov import (Abbreviated). For information about these categories, refer to CTRP Trial Categories,
Study Sources. Otherwise, select Both.

Unable to render {include} The included page could not be found.
Enter the initial letter(s) of the principal investigator's last name. The system suggests names as you type. Select the investigator
name from the list of suggestions.

3. Click Search.
The Search menu options are displayed.

4. Do one of the following:
To search all registered trials in the system, click All Trials.
-orTo search only the trials that you submitted or own, click My Trials. This feature enables access to all the trials that you have submitted,
including those that are currently on hold. (The Clinical Trials Reporting Office staff places trials on hold when they are unable to process
a trial without further information, usually from the submitter.)
-orTo search only the trials that you have saved for later completion, click Saved Drafts.
-orTo clear all search criteria and begin a new search, click Reset.
Allow sufficient time for the system to conduct your search before you run your search again
The search is complete only when the system displays search results or alerts you that it could not find a trial to match your
search criteria.

The trials that meet your search criteria are listed on the Search Results page. For more information on navigating and working with
search results, see Working with Tables and Search Results.

22

Trials may have more than one title. For example, the CTRO staffs may add an alternate title if they find a misspelling in the registered
title. Any trial identified by more than one title is identified in the search results table by an asterisk ( * ) in the Title column.
5. To see the alternate titles associated with a trial, click the asterisk (link).
The list of alternate titles is displayed in the Trial Alternate Titles window.

You can change Accrual Disease terminologies for individual trials
If you searched for "My Trials", the search results table displays an additional column, Accrual Disease Terminology. You can select
a new terminology from the drop-down list only if the trial has not accrued patients.
Additionally, you can change accrual disease terminology at any time for trials currently recording accruals at the summary level only.

6. To view a trial, click its NCI Trial Identifier link. The Trial Details page appears. For information about this page, refer to Viewing Trial Details.
For more information, refer to the following pages:

23

Types of Trials Included in Trial Search Results
The search results table lists the trials that match your search criteria, as well as additional criteria, including a trial processing status. This status reflects
the work of the Clinical Trials Reporting Office (CTRO). The CTRO reviews each trial submitted to the system in order to validate submitted information.
During the validation process, the reviewers check for duplicate records and ensure that the submitter has provided all required information. CTRO does
one of the following as part of the validation process, before abstraction:
If all data is complete and accurate, the reviewers assign the trial the status "Accepted," and the system notifies the submitter by email.
If information is missing, or there are discrepancies in the information provided, the reviewers can place a trial on hold. The CTRO contacts the
submitter for clarification and/or to request missing documents, and resumes processing once the trial is validated.
If the trial is a duplicate (i.e., another user has submitted the same trial), the reviewers assign the trial the status "Rejected," and the system sends
the submitter an email message indicating the status and reason for the rejection. Reviewers may also reject a trial if CTEP/DCP/CCR has
approved the trial. NCI transfers these trials internally.
If you have questions about a rejected trial, contact the CTRO at [email protected]. For more information about this process, refer to Typical
Life Cycle of a Trial and Amendment Process Life Cycle.
The search results table lists the trials that match your search criteria, as well as the following criteria:
Processing status of the trial at the time of the search. For a definition of each status, refer to Trial Processing Statuses.
Submitted - Submitter has registered original trial but CTRO has not validated it yet.
Amendment Submitted - Submitter has submitted amendment but CTRO has not validated it yet.
Accepted - Trial has passed validation.
Rejected - Trial did not pass validation. The search results table does not list these trials.
Abstracted - CTRO has abstracted the trial.
Verification Pending - CTRO has abstracted the trial and has sent the Trial Summary Report (TSR) to the trial submitter for abstraction
verification.
Abstraction Verified Response - Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within
five business days after receiving the TSR.
Abstraction Verified No Response - Submitter has not responded or returned verification feedback to the CTRO within five business
days after receiving the TSR.
User's role with respect to the trial. User roles include the following:
Site Administrator - Has full access to the trials led by the organization (plays lead organization role).
Trial Submitter/Owner - Has full access to the trials they own or submitted.
Other user - Any user other than the trial submitter, owner, or trial's lead organization system administrator.
Trial ownership. Trial ownership types are as follows:
Private trials - Trials submitted or owned by the user who is currently logged in to Registration.
Public trials - Trials submitted by other registered users.
(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's list of Feder
al Holidays.)
The search results table does not list Private trials with a processing status of Rejected nor Public trials with a processing status of Submitted or
Rejected.

24

To navigate the search results table, see Working with Tables and Search Results.

25

Columns in Registered Trial Search Results
Trial records returned from "Search My Trials" and "Search All Trials" options display the following details and actions you can take for each trial when
applicable. The columns available for these details and actions depend on trial ownership types, as follows:
Private trials - Trials submitted or owned by the user who is currently logged in to Registration
Public trials - Trials submitted by other registered users
The following table describes the columns in the search results table:
Column

Displayed
for Public
trials?

Description

NCI Trial
Identifier

Yes

The unique ID assigned to the trial by the CTRP.

Title

Yes

The official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol
document).

Lead
Organizati
on

Yes

The name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and
administrative coordination, study monitoring, and data management activities of the trial.

Lead Org
(Organizat
ion) Trial
Identifier

Yes

The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant
number. Multiple studies conducted under the same grant must each have a unique number.

Principal
Investigat
or

Yes

The

ClinicalTri
als.gov
Identifier

Yes

The unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been
submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT"
followed by 8 numeric characters (such as NCT12345678).

Other
Identifiers

Yes

Identifiers other than Lead Organization Trial Identifier or ClinicalTrials.gov Identifier.

Current
Trial
Status

Yes

The current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. For valid ClinicalTrials.
gov recruitment values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.

Current
(Trial)
Processin
g Status

No

The current status of the trial in the CTRP trial processing work flow. For information, refer to Trial Processing Statuses.

Available
Actions

Yes

Actions that are applicable to the trial according to the processing rules:

Unable to render {include}

The included page could not be found.

Update - Link used to initiate trial updates. For instructions, refer to Updating Trials.
Amend - Link used to initiate trial amendments. Available for trials with processing statuses abstraction verified
(response/no response). For instructions, refer to Amending Complete Trials.
Change Status - Link used to initiate a change to the trial status and status dates. For instructions, refer to Updating
Trial Statuses.
Add My Site - Link used to initiate adding an organization as a participating site. For instructions, refer to Adding Your
Site to Abbreviated Trials.
Update My Site - Link available to Participating Site Record owners to initiate participating site information changes.
For instructions, refer to Updating Participating Site Organization Records.
Request TSR and XML documents (for Complete trials) - Documents are sent via email to all trial owners. For
instructions, refer to Viewing Trial Summary Reports and XML Documents.
Verify Trial Data - Link used to verify open trial records twice per year to ensure that information is accurate and up-todate. For instructions, refer to Verifying Trial Data.
The actions available for a trial depend on its processing status and participating site record ownership.

26

Accrual
Disease
Terminolo
gy

No

The disease terminology for reporting accruals. Keep in mind:
For a trial recording accruals at the patient level, you can specify a new terminology only if the trial has not accrued
patients.
For a trial recording accruals at the summary level, you can change accrual disease terminology at any time.
For information, refer to About Accrual and Recording Trial Details.

(Participati
ng) Sites

Yes

One or more organizations participating in the trial. Click View in the Sites column to view participating site details.

Phase

No

The phase of investigation, as defined by the US FDA for trials involving investigational new drugs. For information, refer to
Trial Phase Value Definitions.

Primary
Purpose

No

The main reason for conducting the trial. For information, refer to Primary Purpose Value Definitions.

Category

No

The category of the trial, as determined by the submission of a full protocol (Complete) or a ClinicalTrials.gov import
(Abbreviated). For information, refer to CTRP Trial Categories, Study Sources.

Trial Start
Date

No

The date on which the enrollment of participants for a clinical study began (or will begin).

Responsib
le Party

No

The party who is responsible for submitting information about a clinical study and updating that information, as defined by
FDAAA. The responsible party can be the sponsor, sponsor-investigator, or sponsor-designated principal investigator.

Sponsor

No

The name of the primary organization that oversees the implementation of the study and is responsible for data analysis,
as defined in 21 CFR 50.3.

Data
Table 4
Funding
Sponsor
Type

No

The type of Data Table 4 funding sponsorship (National, Externally Peer-Reviewed, Institutional, or Industrial). For
information, refer to CTRP Trial Categories, Study Sources.

Record
Verificatio
n Date

No

The date on which the abstracted data for the trial was last verified. ClinicalTrials.gov displays the verification date along
with an organization name to indicate to the public whether the information is being kept current, particularly recruiting
status and contact information. In CTRP, the last verified date is the most recent date on which the CTRO confirmed all of
a clinical study's information in CTRP as accurate and current.

Submitter

No

The name of CTRP user who submitted the trial.

Primary
Completio
n Date

No

The date that the final subject was (or will be) examined or received (or will receive) an intervention for the purposes of final
collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was
terminated (as specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial).

Last
Update
Submitted

No

The date on which the trial was last updated.

Last
Updater
Name

No

The name of the person who last updated the trial.

Last
Amendme
nt
Submitted

No

The date on which the trial was last amended.

Last
Amender
Name

No

The name of person who amended the trial.

On-Hold
Reason

No

The reason why the abstractor put the trial on hold, if applicable.

Trial ownership and current processing status determine which of the trial details and actions listed above are displayed in the Search Results
table. Refer to Trial Processing Statuses.

27

Columns in Draft Trial Search Results
Trial records returned from "Search Saved Drafts" display the following details and actions you can take for each trial when applicable:
Column

Description

Temporary Trial
Identifier

The unique identifier that the system assigned to the saved draft

Title

The official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document).

Lead Organization

The name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and
administrative coordination, study monitoring, and data management activities of the trial.

Lead Organization
Trial Identifier

The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number.
Multiple studies conducted under the same grant must each have a unique number.

Action

Actions that are applicable to the draft trial:
Complete - Link to initiate trial record completion
Delete - Link to initiate trial deletion

Trial ownership and current processing status determine which of the trial details and actions listed above are displayed in the Search Results
table. Refer to Trial Processing Statuses.

28

Viewing Trial Details
The Submitted Clinical Trials Search Results table lists the trials that match your search criteria, as well as additional criteria. For information on that
additional criteria, refer to Types of Trials Included in Trial Search Results.

To view details for a given clinical trial listed on a search results page, click its associated NCI Trial Identifier hypertext link. The details provided for a
given trial depend on the following criteria:
Trial trial ownership types, as follows:
Private trials - Trials submitted or owned by the user who is currently logged in to Registration
Public trials - Trials submitted by other registered users
Data Table 4 Category (Complete or Abbreviated), as described in CTRP Trial Categories, Study Sources.
The Trial Details page displays the metadata as entered by a trial submitter. The following image shows the upper part of the Trial Details page.

29

The system displays responsible party, IND/IDE, NIH grant information and trial-related documents for Private trials only.

To return to the Search Trials page, scroll to the bottom of the Trial Details page, and click Back to Search Results.

30

Exporting Search Results
You can export the results from any search you conduct. You can export them in a format suitable for Microsoft Excel or other spreadsheet application.
How to Export Search Results
1. Conduct a search for the trial(s) of interest. Refer to Searching for Trials.

2. At the bottom left corner of the Search Results page, next to Export Options, click one of the following links:
CSV - Exports comma-separated values to a resultsTrialSearch.csv file
Excel - Exports Excel-formatted data to a resultsTrialSearch.xsl file
A download pop-up dialog box appears.
3. Follow your browser/operating system instructions to view or save the document.

31

Searching for Organization Records
You can search for organizations that are currently registered in CTRP by any of the following criteria:
Organization Identifying Information
PO ID - Enter the exact PO ID only
CTEP ID - Enter all or part of the CTEP ID
Name - Enter all or part of the Organization's name
Family Name. Enter all or part of the Organization Family's name
Organization Address
Country - Select the country from the drop-down list
City - Enter all or part of the organization's primary location
State - Select the state from the drop-down list
Zip Code - Enter all or part of the Zip code
Organization Type. Select one of the following:
Lead Organization - Returns organizations that are Lead Organizations
Participating Site - Returns organizations that are Participating Sites
Both - Returns organizations that are either Lead Organizations or Participating Sites

How to Search for Registered Organizations
1. Click the Search Organizations tab. Or, on the toolbar, click Search > Organizations.

2. Provide as much information as you can about the organization you are looking for, or, enter the Person/Organization (PO) ID or Cancer Therapy
Evaluation Program (CTEP) Identifier. You must enter search criteria in at least one field.
Searching by PO ID
The PO ID you enter for your search criterion must be exact and complete. That is, do not use partial IDs or wildcards.

Using wildcard characters ( % )
You can enter a series of characters in any of the search fields (except the PO ID, which must be an exact match) to narrow the search
results.The system adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type
wildcard symbols (% or *) between characters of the string as necessary.

3.

32

3. Click Search.
The organizations that meet your search criteria are listed in the Search Results table. To navigate the search results table, see Working with
Tables and Search Results.

Tip
If the organization you are searching for is not listed, you may have searched too narrowly (that is, you may have provided too much
information about the organization). If the list of results is very long and contains many organizations that are similar to the one you are
searching for, you can narrow your search by providing more information.
4. If the organization does not appear in the results table, do one of the following to modify your search:
To broaden your search so that more organizations are listed in the search results, delete one or more of your criteria. For example, if
you searched by part of the organization’s name, city, state, and zip code in your original search, you may want to search by state alone.
- or To narrow your search so that fewer organizations are listed in the search results, provide more about your organization. For example, if
you searched by state in your original search, you may want to search by city in addition to the state.
5. To view the details of any organization in the search results list, click its PO-ID.
The Organization Details window displays current information about the organization, including a live web and/or email link that you can use to
contact the organization.

33

Searching for Person Records
You can search for persons that are currently registered in CTRP.

How to Search for Registered Persons
1. Click the Search Persons tab. Or, on the toolbar, click Search > Persons.

2. Provide as much information as you can about the person you are looking for, or, enter the Person/Organization (PO) ID or Cancer Therapy
Evaluation Program (CTEP) Identifier. To search by person role, select a role from the Person Role drop-down list. You must enter search
criteria in at least one field.
Searching by PO ID
The PO ID you enter for your search criterion must be exact and complete. That is, do not use partial IDs or wildcards.

Using wildcard characters ( % )
You can enter a series of characters in any of the search fields (except the PO ID, which must be an exact match) to narrow the search
results.
3. Click Search.
The persons that meet your search criteria are listed in the Search Results table. To navigate the search results table, see Working with Tables
and Search Results.

Tip
If the person you are searching for is not listed, you may have searched too narrowly (that is, you may have provided too much
information about the person). If the list of results is very long and contains many persons that are similar to the one you are searching
for, you can narrow your search by providing more information.
4. If the person does not appear in the results table, do one of the following to modify your search:

34

4.

To broaden your search so that more persons are listed in the search results, delete one or more of your criteria. For example, if you
searched by part of the person’s name, city, state, and zip code in your original search, you may want to search by state alone.
- or To narrow your search so that fewer persons are listed in the search results, provide more about your person. For example, if you
searched by state in your original search, you may want to search by city in addition to the state.
5. To view the details of any person in the search results list, click its PO-ID link.
The Person Details window displays current information about the person.

6. To view the details of the organization with which the person is affiliated, click its PO-ID link.

35

Submitting Clinical Trial Data
This page tree describes how to use CTRP to register, amend, and update clinical trials. The following table describes the circumstances in which you
should use each submission type:
Submission
Type

Description

Registration

Use the Register Trial feature for a trial that has not been registered with CTRP previously. For more information and instructions,
refer to Registering New Trials.

Amendment

Use the Amend Trial feature (for Complete trials only) when changes to the trial involve changes to the protocol document that require
Investigational Review Board (IRB) approval. Amendments include changes that substantively alter any of the following elements:
The treatment administered.
The study design.
The sites in which patients are being enrolled on the trial.
Amendments include all changes (and updates) since the last amendment to the protocol was submitted. For more information and ins
tructions, refer to Amending Complete Trials, including Examples of Amendments.

Update

Use the Update Trial feature when changes to the trial do not substantively affect the scientific conduct of the study, the study design,
and/or the sites in which patients are enrolled on the trial. Update Trial also accommodates certain protocol document changes. For
more information and instructions, refer to Updating Trials, including Examples of Protocol Document Updates.

For more information and instructions, refer to the following pages:

36

Registering New Trials
This page tree describes how to register new National, Externally Peer-Reviewed, and Institutional trials (collectively referred to as Complete trials) in the
CTRP system. (For the definition of Complete, refer to CTRP Trial Categories, Study Sources.) This page tree also describes how to import Industrial trials
from ClinicalTrials.gov for registration in the CTRP. It applies to both interventional and non-interventional trials.
Gather all the protocol data you need before you begin
The system logs you off if it detects that you have not used the application for 90 minutes.

The system locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your
account, contact us at [email protected]. If you have forgotten your password, or if you want to reset it for any reason, refer to Resetting
Your Password.
For instructions, refer to the following pages:

37

About Trial Registration
The way in which you register trials in the CTRP depends on a combination of the trial's Data Table 4 Categorization as either Complete or Abbreviated,
your affiliated organization and its role in the trial, and whether the trial currently is registered in ClinicalTrials.gov with an NCT ID. (For the definition of Com
plete and Abbreviated, refer to CTRP Trial Categories, Study Sources.)
Keep in mind the following points about the entities in CTRP that represent NCI-designated Cancer Centers:
A CTRP organization family represents an NCI-designated Cancer Center family of organizations. For brevity, this guide refers to this entity as a C
ancer Center family, a Cancer Center, or an organization family.
A CTRP organization that is a member of a Cancer Center family is considered a Cancer Center organization. For brevity, this guide refers to this
entity as a Cancer Center organization.
The following table lists the guidelines:
Guidelines
for
Complete
Trials

If your trial is Complete, follow the instructions in Registering New Complete Trials.
Cancer Center trials must meet the following criteria to be eligible for registration:
Trials must have been active as of January 1, 2009 or any time thereafter.
Submitting organization is the Lead Organization or the Coordinating Center.
CTEP or DCP PIO-managed trials must meet the following criteria to be eligible for registration:
If NCI-managed, trials must have been active as of January 1, 2009 or any time thereafter.
If NCI-sponsored, trials must have been still open (not yet Completed) as of December 26, 2007 or opened anytime
thereafter.
Cancer Centers do not register PIO-managed trials or NCI-CCR trials. PIO-managed trials are submitted to
CTRP directly by CTEP and DCP. NCI-CCR trials are managed in ClinicalTrials.gov by CCR.

Guidelines
for
Abbreviated
Trials

If your trial is Abbreviated, registration differs according to a combination of the following trial attributes:
NCT ID (which indicates that the trial has been registered with ClinicalTrials.gov)
Cancer Center type (NCI-designated Cancer Centers or other centers)
NCI grant
Lead organization
Guidelines for Trials with NCT IDs
If the trial is an Industry funded trial, and has an NCT ID, then it can be imported into CTRP from ClinicalTrials.gov in most cases. In
some special cases, however, the trial cannot be imported directly and instead you must contact the CTRO for assistance.
If your organization is not an NCI-designated Cancer Center organization, NIH institute, or pharmaceutical company, you will
need to import the trial directly from ClinicalTrials.gov. For instructions on this process, refer to Registering Abbreviated
(Industrial and Other) Trials.
The system assigns the trial you import from ClinicalTrials.gov the Data Table 4 Category (funding source) Industrial/Other.
(For information, refer to CTRP Trial Categories, Study Sources.) To specify whether the trial is Industrial, or to specify if
an Other trial is National or Externally Peer-Reviewed, contact the CTRO for assistance at [email protected].
For funding source definitions, refer to https://cancercenters.cancer.gov/GrantsFunding/eData#dt4.
If your organization is the Lead Organization on a trial, and your organization is an NCI-designated Cancer Center organization,
do not import the trial from ClinicalTrials.gov. Instead, submit the trial to CTRP as a Complete trial. For instructions, refer to Regis
tering New Complete Trials.
If your organization is the Lead Organization for any trial on anything other than an NCI-designated Cancer Center organization,
NIH institute, or pharmaceutical company trial, the CTRO contacts the Center and further categorizes the trial as Other/National
or Other/Externally Peer-Reviewed based on whether your trial is conducted under an NIH grant, as follows:
If your trial is conducted under an NCI grant, the CTRO categorizes it as a Consortia trial.
If your trial is not conducted under an NCI grant, the CTRO categorizes it as follows:

Other/National, for trials sponsored by an NIH institute
Other/Externally Peer-Reviewed, for trials managed by a hospital or a center other than one designated by the NCI

Guideline
for Trials
without
NCT IDs

If your trial is Abbreviated but does not have an NCT ID, please contact the CTRO for assistance at [email protected]. CTRO
registers these trials manually.

38

Registering New Complete Trials
How to Register New Complete Trials
1. Perform a search for the trial. For instructions, refer to Searching for Trial Records. If the trial does not already exist, proceed to the next step.
(The system uses the Lead Organization ID, Lead Organization Trial ID, and the ClinicalTrials.gov Identifier to detect duplicates. If the system
detects a duplicate, the system does not record your trial.)
2. On the toolbar, click Register Trial, and select your trial's Submission Category (funding source) from the drop-down list, either National, Externa
lly Peer-Reviewed, or Institutional. (For information, refer to CTRP Trial Categories, Study Sources.)
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, click the Help
icon (

) next to each category, or refer to https://cancercenters.cancer.gov/GrantsFunding/eData#dt4.

The Register Trial page appears.
You can expand and collapse sections of the registration page
By default, all sections of the registration form are displayed.
To collapse or expand each section individually, click the Collapse or Expand icon on the right side of the section title as shown in the
figures below.
To collapse all sections, click Collapse All.
3. In the various fields, specify the appropriate information. The following table describes the fields.
Tip
Be sure to provide information for all fields marked with an asterisk (*). If you cannot complete the registration of a trial in one
Registration session, you can save a draft of the trial details you have completed. (Refer to "Save as Draft" below.) Later you can
return to complete the registration in another session.

Field
Label
Various

Description/Instructions

In the various fields, specify information as appropriate according to the detailed instructions provided for each of the following
sections:
a. Recording Trial Identification Information
b. Recording Trial Details
c. Recording Lead Organizations and Principal Investigators
d.

39

d.
e.
f.
g.
h.
i.
j.
k.

Recording Sponsors and Responsible Parties
Recording Data Table 4 Information
Recording NIH Grants
Recording Trial Statuses
Recording Trial Dates
Recording INDs and IDEs
Recording Regulatory Information
Uploading Trial-Related Documents

Save
as
Draft

Click to save a draft of the record so that you can complete the registration at another time. You must have provided, at the
minimum, both the Lead Organization and Lead Organization Trial Identifier to save a draft.
The system saves your draft, assigns it a unique ID (for tracking purposes), and sends you an email message confirming that the
information has been saved. You can end your Registration session and retrieve your draft later to complete the registration.

Review
Trial

Click to initiate the system check for errors and missing information. The system displays the results in a message at the top of the
Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to submit the trial.
The Review Trial Details page is read-only. To make changes to the trial data, follow the instructions in Editing Trial Details.

Cancel

Click to cancel the registration. A pop-up message prompts you to confirm cancellation.
If you choose to cancel the registration, you will lose all data that you may have entered.

4. To continue with the trial registration, scroll to the bottom of the Review Trial Details page, and then click Submit. To prevent creating a
duplicate record, do not click Submit more than once. If you have to make changes after you click Submit, contact the CTRO at [email protected].
gov rather than using your browser's Back button to make changes.
The registration notification message system sends you an email message to acknowledge that the trial has been submitted. Later it sends
another email message to notify you when your trial has been accepted or rejected.
After submission, most users other than the trial submitter can not see the trial information you provided until the information has been
validated. However, an organization administrator (if one exists) and an assigned owner can access the information prior to validation.

40

Recording Trial Identification Information
You must provide a Lead Organization trial identifier for each trial you register. Optionally, provide a ClinicalTrials.gov Identifier.

How to Complete the Trial Identifiers Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required
field.

Instructions for recording Trial Identifiers for Complete trials
Field
Label

Description/Instructions

Lead
Organizat
ion Trial
Identifier*

Enter the unique identification assigned to the protocol by the sponsoring organization, exactly as it appears in the protocol document. For
Inter-Group trials, type the Lead Group's trial number. For multi-site trials that have no assigned single center, use the protocol ID, for
example, NSAGP-B-40.

ClinicalTr
ials.gov
Identifier

If the trial has been submitted to ClinicalTrials.gov previously, enter the number assigned to the trial by PRS (ClinicalTrials.gov).
The CTRP renamed the previous identifiers "NCT Number" and "NCT ID" to "ClinicalTrials.gov Identifier".

You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make changes thereafter, contact the
CTRO at [email protected].

When you submit the trial, the system checks the ClinicalTrials.gov identifier you entered to ensure that no other registered trial
has the same one. The system displays an error message if it finds another trial with the same ClinicalTrials.gov identifier. If this
occurs, check the number you entered and try again. If you are certain that the number you entered is correct, contact the CTRO
at [email protected].

Other
Trial
Identifier

Enter an additional trial identifier such as unique identifier from other registries, NIH grant numbers, or protocol numbers assigned by the
Review Board, and then click Add Other Identifier. Repeat this step for each additional identifier.
The ID you added is displayed in the Other Identifier list.
To delete an identifier you have added, in the Action Column, click Delete.

41

Recording Trial Details
How to Complete the Trial Details Section
1. In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Field
Label

Description/Instructions

Title*

Enter the official name of the protocol provided by the study principal investigator or sponsor. (Limit 4000 characters)
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of
the Prostate"

Phase*

Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. For valid values, refer to Trial
Phase Value Definitions.
Select N/A for observational and ancillary-correlative trials.

Is this a
Pilot?

Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.

Trial Type*

Select the trial type indicated in the protocol.

2. If you selected interventional as the trial type, select or enter the appropriate information in the following fields. The following table describes the
fields. An asterisk (*) indicates a required field.
Field
Label

Description/Instructions

Primar
y
Purpos
e*

a. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.
b. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.

Second
ary
Purpose

a. Select one of the following reasons for conducting the trial.

Accrual
Diseas
e
Termin
ology*

The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the
character numbers as you type.

Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a
condition and a potential causal factor of the condition.
Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize
patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked
to an active clinical research study and should include only patients accrued to that clinical research study. Report
only those studies that can be linked to individual patient or participant data.
Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to
therapies, etc. Report only those studies that can be linked to individual patient or participant data.
Other. Any purpose other than Ancillary-Correlative.
b. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Click to select the disease terminology used to report subject accruals for this trial.

3. If you selected non-interventional as the trial type, select or enter the appropriate information in the following fields. The following table describes
the fields. An asterisk (*) indicates a required field.
Field
Label
NonInterve
ntional
Trial
Type*

Description/Instructions

Select one of the following trial types:
Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the
participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the
study may receive diagnostic, therapeutic, or other interventions but the investigator of the observational study is not
responsible for assigning specific interventions to the participants of the study.
Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition
and a potential causal factor of the condition.

42

Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or
other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active
clinical research study and should include only patients accrued to that clinical research study. Report only those studies
that can be linked to individual patient or participant data.
Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies,
etc. Report only those studies that can be linked to individual patient or participant data.
Primar
y
Purpos
e*

a. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.
b. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier,
either Observational or Ancillary -Correlative , in the text field.
The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the
character numbers as you type.

Study
Model
Code*

a. Select the primary strategy for subject identification and follow-up. The following list provides valid values.
Cohort. Group of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who
are examined or traced over a given time period
Case-control. Group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with
different characteristics, but otherwise similar
Case-only. Single group of individuals with specific characteristics
Case-crossover. Characteristics of case immediately prior to disease onset (sometimes called the hazard period)
compared to characteristics of same case at a prior time (i.e., control period)
Ecologic or community studies. Geographically defined populations, such as countries or regions within a country,
compared on a variety of environmental (e.g., air pollution intensity, hours of sunlight) and/or global measures not
reducible to individual level characteristics (e.g., health care system, laws or policies median income, average fat intake,
disease rate)
Family-based. Studies conducted among family members, such as genetic studies within families or twin studies and
studies of family environment
Other. Any model not described above
b. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.
The text field is displayed only after you have selected Other.

Time
Perspe
ctive
Code*

a. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
Prospective - Look forward using periodic observations collected predominantly following subject enrollment
Retrospective - Look back using observations collected predominantly prior to subject selection and enrollment
Cross-sectional - Observations or measurements made at a single point in time, usually at subject enrollment
Other - Any time perspective not described above
b. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.
The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the
character numbers as you type.

Site
Princip
al
Investi
gator*

Click Look Up Person and search for the principal investigator. For instructions, refer to Looking Up Registered Persons.

43

Recording Lead Organizations and Principal Investigators
The Lead Organization is the institution that is the principal administrative organization responsible for the study. Each trial can have one Lead
Organization only.
You must complete both fields in the Lead Organization/Principal Investigator section.
Tip
The Principal Investigator is the individual who is responsible and accountable for conducting the clinical trial. The PI assumes full responsibility
for the treatment and evaluation of human subjects, and for the integrity of the research data and results.

How to Complete the Lead Organization/Principal Investigator Section
1. Next to the Lead Organization field, click Please Select the Lead Organization.
The system displays your affiliated organization first, followed by affiliated organization family members. Organizational roles are displayed when
applicable.

2. Select the appropriate organization from the list. If the organization is not listed, click Search, and search for the organization as per the
instructions in Looking up Registered Organizations. (If the search does not return your trial's lead organization, you can ask the CTRO to create
the organization record. To do so, follow the instructions in Requesting Creation of an Organization Record.)
3. Next to Principal Investigator click Look Up Person, and search for the principal investigator as per the instructions in Looking Up Registered
Persons. (If your trial's principal investigator's name is not listed, you can ask the CTRO to create the person record. To do so, follow the
instructions in Requesting Creation of a Person Record.)

44

Recording Sponsors and Responsible Parties
Complete this section only if you require an XML document to register your trial with ClinicalTrials.gov.
The Responsible Party can be either a sponsor, principal investigator (PI), or sponsor/investigator. The term "responsible party" is either of the following:
1. Sponsor. Name of the primary organization that oversees the implementation of the study and is responsible for data analysis. For applicable
clinical trials, sponsor is defined in 21 CFR 50.3.
- or 2. Principal Investigator. The individual who serves as the principal investigator and is designated as responsible party, consistent with the
conditions described in the statute.
- or 3. Sponsor-Investigator: The individual who both initiates and conducts the study.
For further elaboration on the definition of these roles with respect to responsible party, refer to http://prsinfo.clinicaltrials.gov
/ElaborationsOnDefinitions.pdf.
The fields displayed in the Sponsor/Responsible Party section depend on your selection of the Responsible Party role:
If you select Sponsor, you do not submit any further information about the Responsible Party.
If you select Principal Investigator, this section expands to display the investigator's title and organization affiliation. The system populates the
Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
If you select Sponsor-Investigator, this section expands to display the investigator's title and organization affiliation. Although the system
populates the Investigator's name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator
section, you can select another person for this role.
How to Complete the Sponsor/Responsible Party Section
1. Complete the Lead Organization/Principal Investigator section, as described in Recording Lead Organizations and Principal Investigators. Doing
so will ensure that the Sponsor/Responsible Party section is pre-populated when applicable.
2. In the Sponsor/Responsible Party section, select or enter the appropriate information in the text fields and drop-down lists. The following table
describes the fields. An asterisk (*) indicates a required field.
Field
Label

Description/Instructions

Spons
or

Click Look Up Sponsor and search for the organization as per the instructions in Looking Up Registered Organizations.

Respo
nsible
Party

Indicate the party who is responsible for the trial. Select one of the following options:

Investi
gator*

If the Responsible Party is the Principal Investigator, you can not change the person's name.

Sponsor. Name of primary organization that oversees implementation of study and is responsible for data analysis. If you
select this role, you do not submit any further information about the Responsible Party.
Principal Investigator. Primary medical researcher in charge of carrying out a clinical trial's protocol. If you select this role, this
section expands to display the investigator's title and organization affiliation. The system populates the Investigator's Name field
with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
Sponsor-Investigator. The individual who both initiates and conducts the study. If you select this role, this section expands to
display the investigator's title and organization affiliation. The system populates the Investigator's Name field with the name you
selected as Principal Investigator in the Lead Organization/Principal Investigator section.

If the Responsible Party is the Sponsor-Investigator, you can change the person's name. To do so, click Look Up Sponsor, and
follow the instructions in Looking Up Registered Persons.
Investi
gator
Title*

The system populates this field. Enter a new title in the field provided if other than Principal Investigator.

Investi
gator
Affiliati
on*

If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To do so, click Look Up
Organization, and follow the instructions in Looking Up Registered Organizations.
If the Responsible Party is the Sponsor-Investigator, you can not change the affiliated organization.

45

Recording Data Table 4 Information
Complete all fields in the Data Table 4 Information section. The Trial Submission Category (study source) or Data Table 4 Funding Sponsor Type fields are
pre-populated with the sponsor type.
The lead organization or at least one participating site must be a Cancer Center organization.

How to Complete the Data Table 4 Information Section
1. Hover your mouse over Please Select the Data Table 4 Sponsor Organization. A list of organizations appears.
2. Select the name of the external sponsor or funding source as defined by the Data Table 4 report. Refer to Looking Up Registered Organizations.
(If your trial's funding sponsor is not listed, you can ask the CTRO to create the organization record. To do so, follow the instructions in Requesting
Creation of an Organization Record.)

The organization you selected appears under the Data Table 4 Funding Sponsor field, along with an option to delete the sponsor.

A trial can have multiple sponsors. Repeat the steps above to add other sponsors. The system ensures that you don't duplicate an
existing sponsor.
3. To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
If you have selected a lead organization for the trial and if that lead organization belongs to an organization family, the Program Code field is
available. The Program Code field lists all program codes available for that organization family. If you are a site administrator, an option to
manage program codes is also available.
4. If you want to specify a program code for the trial, select one or more codes in the Program Code field.
5. If you want to manage program codes, save a draft of the trial details you have completed. (Refer to "Save as Draft" in Registering New Complete
Trials.) Then you can do one of the following:
a. Retrieve that draft trial for completion (as described in Completing and Deleting Saved Drafts), return to this Data Table 4 Information
section, and click Manage Program Codes.
b. On the toolbar, click Administration > Program Codes > Manage Master List.

46

Recording NIH Grants
This section pertains to Complete trials. You must record NIH grant information for your trial, including the funding mechanism, institute code, serial
number, and NCI division/program. You can add up to five NIH grants.
If the Lead Organization for the trial is a Cancer Center organization, you must record a valid P30 grant.

For a complete guide to NIH grant information, refer to the Grants and Funding page at http://grants.nih.gov/grants/funding/funding_program.htm.
How to Complete the NIH Grant Information Section
1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section
are required if your study is funded by NIH.
Instructions for recording NIH Grant Information
Field
Label

Description/Instructions

Is this
trial
funded by
an NCI
grant?

If the trial is funded in part or whole by an NCI Grant or Contract, select Yes. Otherwise, select No.

Enter the initial letter(s) and or number(s) in the Funding Mechanism field and then select the NIH unique identifier from the dropFunding
Mechanism down list. The funding mechanism is a 3-character code used to identify areas of extramural research activity applied to funding
mechanisms.
Tip
Click the down arrow in the field, and then use the up and down arrow keys on your keyboard to scroll up and down
the drop-down list. When you arrive at the appropriate code, press the ENTER key.
For a list of valid codes, refer to Funding Mechanism Code Values.
Institute
Code

Select the two-letter code identifying the first major-level subdivision, the organization that supports an NIH grant, contract, or
inter-agency agreement. The support may be financial or administrative.
For a list of valid codes, refer to NIH Grant Institute Code Values.

Serial
Number

Enter the five- or six-digit number generally assigned sequentially to a series within an Institute, Center, or Division, for example,
123660. If you selected CA in the Institute Code field, the system displays the top ten grants that match the sequence of serial
numbers as you type them one-by-one. By selecting a grant from the list, you ensure that you record a valid serial number.

NCI
Division
/Program

Enter the initial letter(s) of the division or program, and then select the organizational unit that provides funding for the study, from
the drop-down list.
For a list of Divisions and Programs, refer to NCI Division and Program Values.

2. Click Add Grant.
The Add button is operable only after you have provided the grant information in all fields.

The grant is displayed and added to the trial, and the Grant fields are reset.
3. If your trial is funded by more than one grant, repeat the steps above, and then click Add Grant.
4. To delete a grant record from a trial, in the Action column, click Delete.

47

Recording Trial Statuses
Trial status refers to the current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants/patients.
Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. For valid ClinicalTrials.gov recruitment values, refer to Trial
Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.
If you register a trial after it has reached any Closed to Accrual related trial status or a Complete trial status, you must create a complete Trial Status
History by adding all previous statuses in order, as per the rules provided in Status Transition Rules.
How to Complete the Trial Status Section

1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section
are required.
Field
Label

Description/Instructions

Trial
Status
Date*

Enter the date on which the current trial status became effective.

Trial
Status

Select the trial’s accrual status from the drop-down list. For valid values, refer to Trial Status Values in the CTRP and ClinicalTrials.
gov and Expanded Access Statuses.

Why
Study
Stopped

If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study
has ended or is not currently accruing, using up to 160 characters. As you type, the number of characters remaining is displayed
below the text field.

2. Click Add Status.
The new status record is displayed.

3. If the system indicates that the status you added is invalid, do one of the following.

48

To edit the status, in the Actions column, click the Edit icon and make changes as indicated in the Error and/or Warning message.

To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record, and then
add the correct status information.
The system does not change the status of participating sites when you close a trial.

49

Recording Trial Dates
The Trial Dates section captures start, primary completion, and completion dates.

How to Complete the Trial Dates Section
1. In the various date fields, specify dates as they occur according to the rules specified in Status Rules for Trial Dates. The following table
describes the fields. In this table, an asterisk (*) indicates a required field and an asterisk within square brackets ([*]) indicates a conditionally
required field.
Field Label

Description/Instructions

Trial Start Date*

Enter the date on which the trial started, or is expected to start.

Primary Completion
Date [*]

Enter the date on which the final subject was examined or received an intervention, or the date on which that is
expected to happen.
Primary Completion Dates are optional in the following cases:
For non-interventional trials.
For DCP trials, if you select N/A as the type.
In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov. Otherwise,
Primary Completion Dates are required.

Completion Date

Enter the final date on which data was (or is expected to be) collected for the trial.

In the Primary Completion Date field, the N/A option is available only for Non-Interventional trials and for Interventional DCP trials.
2. Indicate whether each date you entered is Actual or Anticipated, according to the rules specified in Status Rules for Trial Dates.
3. To clear the selection of Actual or Anticipated for the Primary Completion Date of a non-interventional trial, clear the Primary Completion Date and
click Review Trial. (If the page indicates any errors, resolve them and click Review Trial again.)

50

Recording INDs and IDEs
Enter the IND/IDE number and grantor fields only if your trial is/was conducted in the United States. You must indicate whether your trial qualifies as an
Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.
There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.
How to Register IND/IDE Trials
1. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.

Instructions for recording IND/IDE Information
Field Label

Description/Instructions

IND/IDE Types*

If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational
Device Exemption, select IDE.

IND/IDE Number*

Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device
Exemption (IDE)
IND number formats
You can enter the IND number in many formats. For example, for a biologics (BB) IND that
contains the number 1234, you can type BB1234, 1234, or BB_1234.
For IDE trials, type the IDE number associated with the grant.

IND/IDE Grantor*

Select one of the following organizations that holds the IND/IDE approval:
a. For IND trials:
i. Center for Drug Evaluation and Research
ii. Center for Biologics Evaluation and Research
b. For IDE trials:
i. Center for Devices and Radiological Health
ii. Center for Biologics Evaluation and Research

IND/IDE Holder Type*

Select one of the following holder types:
a.
b.
c.
d.
e.

Investigator
Organization
Industry
NIH
NCI

NIH Institution, NCI Division
/Program Code* (required if
the holder type is NIH or NCI)

Select a code from the drop-down list.

Availability of Expanded
Access

If the drug, biologic, or device product is known to be available outside any clinical trial protocol, select Yes.
If it is known to be unavailable outside any clinical trial protocol, select No. Otherwise, select Unknown. If
you select Yes in this field, the Expanded Access Record field becomes available.

Expanded Access Record

Specify the ClinicalTrials.gov identifier (NCT ID) for the associated Expanded Access record. Also, consider
specifying each of these trials as an Associated Trial for the other. For instructions, refer to Associating Trials.

If you selected NIH from the IND/IDE Holder Type list, refer to NIH Institution Code Values for valid
values.
If you selected NCI from the IND/IDE Holder Type list, refer to NCI Division and Program Values for
valid values.

2. Click Add IND/IDE.
3. To delete an IND/IDE record from a trial, in the Action column, click Delete.
4. Optionally, to add another IND/IDE record, repeat the steps above.

51

Recording Regulatory Information
Complete this section only if you require an XML document to register your trial with ClinicalTrials.gov.

How to Complete the Regulatory Information Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required
field. For a definition of each field, refer to http://prsinfo.clinicaltrials.gov/definitions.html.

Instructions for recording regulatory information
Field Label

Description/Instructions

Studies a U.S.
FDA-regulated
Drug Product

If the trial studies one or more U.S. FDA-regulated drug or biologic products (a drug subject to section 505 of the Federal Food,
Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act), select Yes. Otherwise,
select No.

Studies a U.S.
FDA-regulated
Device Product

If the trial studies one or more U.S. FDA-regulated device products (a device subject to section 510(k), 515, 520(m), or 522 of the
Federal Food, Drug, and Cosmetic Act), select Yes. Otherwise, select No. If you select Yes in this field, the Unapproved/Uncleared
Device field and Pediatric Post-market Surveillance field become available.

Unapproved
/Uncleared
Device

This field is read-only. The default value is No, which indicates the release of trial information on Cancer.gov is not being delayed
until after an interventional device has been approved or cleared. You may request a change in the value for this field by submitting
a request to the CTRO at [email protected].

Pediatric Postmarket
Surveillance

If the U.S. FDA has ordered a pediatric post-market surveillance of the device product, select Yes. Otherwise, select No.

Product
Exported from
the U.S.

If the product is manufactured in the U.S. or one of its territories and exported for study in a clinical trial in another country, select Y
es. Otherwise, select No.

FDA Regulated
Intervention
Indicator

If the trial is regulated by the FDA, select Yes. (If the trial includes an IND or IDE, you must select Yes.) Otherwise, select No. If
you select Yes in this field, the Section 801 Indicator field becomes available.

Section 801
Indicator

If the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801, select Yes.
Otherwise, select No.

Data Monitoring
Committee
Appointed
Indicator

Optionally, if a data monitoring committee has been appointed for this trial, select Yes. Otherwise, select No.
This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment
Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory
affairs office.

52

Uploading Trial-Related Documents
When registering Complete trials, you must upload the following types of documents:

Complete clean Protocol document.
IRB Approval.
List of Participating Sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact information.
Informed Consent (if not included in the protocol document).
Currently, the system requires you to supply each of your documents as one of the following formats:
Microsoft Word (.doc, .docx, or .docm).
Adobe PDF. Adobe PDF files require special processing. For information about creating PDFs, refer to Converting Files to PDFs.
Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb).
WordPerfect.

How to Submit Trial Related Documents
1. Next to the document-type field, (such as Protocol Document), click Browse.
2. Follow your browser/operating system instructions to navigate to, select, and open the appropriate document.
3. Repeat the steps above for each type of document.
Adding Multiple "Other" Documents
You can upload more than one (1) "Other" document. After you have uploaded the first of your "Other" documents, click the Add More
link. The system displays a new Other document field.

53

Converting Files to PDFs
Abstractors use the information provided in the documents you upload in Registration to validate and complete trial data in Protocol Abstraction (PA). To
facilitate data entry, the abstractors may copy and paste information from your documents into fields in the PA interface.
Trial-related documents uploaded as Microsoft Word (.doc), Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb), and WordPerfect files contain text that abstractors
can copy and paste directly. PDFs (portable document format) contain text that abstractors can copy only if the content was created from other textbased applications such as Word or Excel.

Abstractors can not copy and paste text from scanned documents
Avoid uploading PDFs of scanned documents. They can not be edited, copied, or read with OCR (optical character recognition)
applications.
Adobe provides a plug-in for most text-based word processing applications that enables you to convert your files to PDFs. Once you have
converted the files, you can read the documents in Adobe Reader. Others can read the content as well but are not able to make changes to your
file. You can download the Adobe PDF Reader for free from the Adobe website
.
Microsoft provides instructions for converting files to PDFs both on their website

and in the Help documentation in each of its applications.

When searching for help, use "save file as pdf" as the search term.

You do not need a document converter in Mac OSX. Instead, print your documents to a PDF file.
How to Convert Text-Based Files to PDFs in Mac OSX
1.
2.
3.
4.

Open your text file in its original format (such as .doc or .xls).
Click File > Print.
In the Print window, click the PDF button at the bottom-left and select the Save as PDF option.
Choose the file location, rename your PDF file, and then click Save.

54

Registering Abbreviated (Industrial and Other) Trials
You can register Industrial/Other trials in the CTRP by importing them directly from ClinicalTrials.gov. You must enter a ClinicalTrials.gov Identifier (NCT
ID) for each trial you register. If the trial you want to register does not have an NCI ID, or if you do not know it, contact the CTRO for assistance at ncictro@
mail.nih.gov.
The system registers the trials you import from ClinicalTrials.gov as Abbreviated trials. To classify a trial as "Other", contact the Clinical Trials
Reporting Office staff at [email protected] after importing/registering the trial in the CTRP system.
For more information about Data Table 4 categorization, see Guidelines for Abbreviated Trials.
How to Register Industrial Trials
1. On the toolbar, click Register Trial, and select Industrial/Other.
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, or, click the Help
icon (

) next to each category.

The Import ClinicalTrials.gov Trials page appears.
2. Enter the ClinicalTrials.gov Identifier, and then click Search Studies. The system searches for the ID you entered. If it finds a match in the CTRP,
you can not import the trial.
3. If the system does not find a match in the CTRP, the trial record from ClinicalTrials.gov appears.
4. Click Import Trial From ClinicalTrials.gov.
While it is possible for two users to attempt to import a trial at the exact same time, the system cannot process simultaneous imports. If
you receive an error message the first time you attempt to import a trial, wait a short while, and then try again.
The trial is registered in the CTRP and assigned a unique NCI identifier with the processing status Submitted. The system synchronizes the
imported record in the CTRP with the one in ClinicalTrials.gov.
5. To add your site as a participant in the trial, click Add My Site. The Add Participating Site page appears. The Participating Site list contains all
organizations in the Organization Family associated with your CTRP account.
6. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page appears.
7. Complete the fields as per the instructions in Adding Your Site to Abbreviated Trials, and then click Save. The system sends you an email
message when the CTRO has accepted the trial for registration in the CTRP. If your trial is not Industrial, contact the CTRO at [email protected].
gov to request categorization of the trial as either National or Externally Peer-Reviewed.
The system synchronizes Industrial and Other trials currently registered in the CTRP with ClinicalTrials.gov trials every night by comparing their
ClinicalTrials.gov Identifiers. The system updates CTRP trial records with the data imported from ClinicalTrials.gov if it finds matching records.
The CTRP system does not import Person information from ClinicalTrials.gov.

55

Printing Trial Information
You can print a copy of the trial details to facilitate the review and/or keep for your records. You must review the trial in order to access the print feature.
How to Print Trial Information
1. Scroll to the bottom of the Register Trial page, and then click Review Trial. If necessary, provide any missing information.
2. Scroll to the bottom of the Review Trial Details page, and then click Print.

56

Editing Trial Details
You can edit the details of the trial that you are registering before you submit the trial to the CTRP. If you want to edit a registered trial that you own, follow
the instructions in Updating Trials.
How to Edit Trial Details
1. Scroll to the bottom of the Register Trial page, and then click Review Trial.
2. Scroll to the bottom of the Review Trial Details page, and then click Edit.
The Register Trial page displays all information you have provided in editable form.
3. Make changes as necessary, and then click Review Trial.
4. After you have reviewed your edits, click Submit.

57

Completing and Deleting Saved Drafts
During the course of registering a trial, you can save the information you have already provided as a draft, and return to it later. Once you retrieve your
draft, you can complete the registration or delete the draft altogether.
How to Complete or Delete Saved Drafts
1. Retrieve the draft by searching for it using the Search Saved Drafts option. (For details, refer to Searching for Trials.) Saved draft records are
listed on the Search Results page.

2. Do one of the following in the appropriate Action column on the right side of the table:
a. To delete the record, click Delete. The draft record is deleted from the system permanently.
- or b. To complete the record, click Complete.
The Register Trial page displays all the information you provided previously. You can complete the rest of the information by following the steps in Registeri
ng New Complete Trials.

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Amending Complete Trials
This page tree describes how to use CTRP to amend clinical trials. The ability to amend a trial depends on multiple factors, as described in the following
table:
Factor

Description

Who can amend a
trial?

Only the trial owner. A trial may have more than one owner. To request ownership of a trial, contact your Site Administrator. (If
you are a Site Administrator, refer to Managing Trial Ownership.)

What types of trials
can be amended?

Only National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP previously. For
information, refer to CTRP Trial Categories, Study Sources.

At which trial
processing statuses
can a trial be
amended?

Only trials that have reached the Abstraction Verified Response or Abstraction Verified No Response processing status. For
information, refer to Trial Processing Statuses. The CTRO reviews and abstracts amended trial data just as it does with original
submissions.

At which trial statuses
can a trial be
amended?

Only trials that have reached the In Review or Approved trial status. You can not amend trials in the Complete, Administratively
Complete (Terminated), or Withdrawn status. For valid ClinicalTrials.gov recruitment values, refer to Trial Status Values in the
CTRP and ClinicalTrials.gov and Expanded Access Statuses.

Which parts of a trial
record can be
amended?

Any part except:
NCI trial identifier number
NIH grant number
IND/IDE serial number

Most of the information, including documentation, that is required for original submissions is also required in amendments. To ensure that these
requirements are met, you can review, edit, and print your amended data using the Registration features prior to submission.

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Amendment Process Life Cycle
The CTRP processes submissions in much the same way as it processes original trial data. (For information, refer to Typical Life Cycle of a Trial.) You
may need to submit an amendment more than once during the course of your study, and the process is repeated each time you submit an amendment.
The progression of your trial throughout the phases of the life cycle relies on a series of communications. These communications take the form of email
messages between you and the system at certain milestone events, as follows:
1. The system sends you a submission confirmation letter.
2. The CTRO validates the new data and documents you provided, and the system sends you an acceptance (or rejection) message.
a. If the amendment is rejected, the system provides the reason for rejection and reinstates your latest verified trial submission.
b. If your amendment is accepted, the CTRO abstracts all the trial details.
3. When abstraction is complete, the CTRO sends you a Trial Summary Report (TSR) that includes all the newly-modified data in the CTRP.
4. You review and validate the new TSR and email your approval to the CTRO.
5. If you request a change, the CTRO makes corresponding modifications and re-sends the TSR.
The amended trial appears in your Search My Trials results list upon acceptance.
The TSR contains all the information that you submitted and all the trial data abstracted by the CTRO.

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Amendment Rules
In your role as trial owner (original submitter or current owner), you can amend only Complete trials. The trials you own are listed when you use the Search
My Trials feature. Refer to Searching for Trials. In addition to rules provided in Registering New Trials, the following rules apply to amendments:
You can create a new NIH grant record only if you can provide all of the following details:
Funding Mechanism
NIH Institution Code
Serial Number
NCI Division/Program
You can not change the following existing information:
NCI trial identifier number
NIH grant number
IND/IDE serial number
The following list is the minimum set of required documents that must be submitted with each amendment:
Protocol document.
IRB approval document.
A change memo document or protocol highlighted document:
A change memo is a document that contains a summary of changes as compared to the original, or last amended, trial
submission.
A protocol highlighted document is a document that has been marked up, with or without using a Track Changes feature.
List of participating sites and contact information (for multi-site trials, if not included in the protocol document).
Informed consent (if not included in the protocol document) and only when there are documented changes to the consent.
When you are submitting an amendment, we recommended that you provide any additional documents that you think will be useful to the CTRO for
reviewing and processing the amendment document.
A trial may have more than one owner. Review the recorded information carefully to see if another owner has modified the trial.

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Examples of Amendments
The following are examples of amendments that the Amend Trial feature accommodates.
Dose Escalation Amendment (change in the number of patients treated at a given dose level)
Change in Sites Open to Patient Accrual
Change in Principal Investigators
Change in Risk to Participants (new risk identified [new CAEPR], changes made as a result of an updated Severe Adverse Event)
Scientific Change (opening an arm, adding a new arm, closing an arm, changing objectives, changing statistical analysis, adding correlative
studies, increase or decrease in the accrual goal, changing from Phase I to Phase II, additional data points)
Correction of Typographical Errors which Change Scientific Meaning (mg vs. mcg)
Eligibility Change (change to the inclusion or exclusion criteria)
Therapy Change (change in dose, adding another agent, change in administration, change in route)
To open the trial record for amending, refer to Amending Trials.

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Amending Trials
How to Amend Trials
1. On the toolbar, click Search > Clinical Trials. The Search Trials page appears.
2. Click Search > My Trials. The Search Results page displays the results of your search and actions available (if any) for each record.

3. In the Available Actions column, click Select Action > Amend. The Amendment Trial page displays the data currently registered with the CTRP.
4. Make changes to the fields as necessary. The system requires you to provide information for all fields marked with an asterisk (*). The
instructions are the same for trial registration and trial amendment, with some exceptions:
In the Amendment Details section, specify the appropriate information in the various fields. The following table describes the fields.
Field Label

Description/Instructions

Amendment Number

Enter an appropriate number.

Amendment Date*

Select or enter an appropriate date.

You can select a different disease code only if the trial has not accrued any subjects to date.
A trial can accumulate program codes from different organization families. For example, a participating site might belong to a different
organization family than the lead organization. When you amend a trial, the Program Code field displays all codes from the master list for
the organization family of the lead organization.
Primary Completion Dates are optional for non-interventional trials and for DCP trials. In both cases, the system excludes such trials
when submitting XML documents to ClinicalTrials.gov. Otherwise, Primary Completion Dates are required.
The system does not change the status of participating sites when you close a trial.
For instructions on recording each field otherwise, refer to Registering New Trials.
5. Review the amendment. Refer to Reviewing and Submitting Trial Amendments.
6. Submit the amended trial to the CTRP. The system sends you an email notification — with the details of what has changed — whenever you
amend accepted trials.

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Reviewing and Submitting Trial Amendments
After you have completed updating the trial, review the information for errors and edit any details that do not match the changes in your change memo or
other source. You can print a copy of the Amend Trial pages to facilitate the review and/or keep for your records.
How to Review and Submit Trial Amendments
1. Complete all modifications to the most recent trial submission.
2. Scroll to the bottom of the Amendment Trial page, and click Review Trial.
The system checks for errors and missing information and displays the results in a message at the top of the Review Trial Details page. Indicators
mark specific fields that you must complete or correct in order to submit the trial.
3. Correct any errors if indicated, and repeat the previous step as many times as necessary until the amendment is error-free.
The Review Trial Details page is read-only. To edit information that you have reviewed, see Editing Amended Trials.

4. Click Submit.

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Printing Amended Trial Information
You can print a copy of the amended trial to facilitate the review and/or keep for your records. You must review the amendment in order to access the print
feature. For instructions on reviewing the trial, see Reviewing and Submitting Trial Amendments.
How to Print Amended Trial Information
1. Review the amended trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.

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Editing Amended Trials
You can edit your amended trial details after you have reviewed them at any time before you submit them to the CTRP.
How to Edit Amended Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit.
The Amendment Trial page displays all information you have provided in editable form.
2. Make changes as necessary and then follow the instructions in Reviewing and Submitting Trial Amendments.
Editing Trial-Related Documents
The Edit Trial page lists all documents that were submitted with previous trial submissions. You can view, but not delete these documents.
However, you can remove/replace the documents associated with the amendment you are submitting.

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Updating Trials
This page tree describes how to use CTRP to update clinical trials that are currently registered and verified in CTRP. The ability to update a trial depends
on multiple factors, as described in the following table:
Factor

Description

Who can update a trial?

Only the trial owner. A trial may have more than one owner. To request ownership of a trial, contact your Site
Administrator. (If you are a Site Administrator, refer to Managing Trial Ownership.)

What types of trials can be
updated?

Only trials that have been registered with the CTRP previously.

At which trial processing statuses
can a trial be updated?

Only trials that have been previously accepted. (That is, the processing status must be Accepted or a subsequent
processing status.) For information, refer to Trial Processing Statuses.

Which parts of a trial record can
be updated?

Only a subset of the information included with the original trial submission. For details, refer to Trial Attributes You
Can Update.

What types of changes can be
made as a trial update?

Only changes that do not require Investigational Review Board (IRB) approval. For examples, refer to Examples of
Protocol Document Updates.

You can also update the trial status and trial status start/completion dates without having to update other trial details. For instructions, refer to Updating
Trial Statuses.
For instructions, refer to the following pages:

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Trial Attributes You Can Update
As trial owner, you can update a subset of the information included with the original trial submission, including the following:
ClinicalTrials.gov Identifier (other than Industrial/Other trials)
Other Identifier
Local Trial Identifier (Industrial/Other trials)
Title (other than Industrial/Other trials)
Accrual Disease Terminology (other than Industrial/Other trials)
NIH grant information (for NIH-funded trials).
You can add grants but you can not update existing grant information.

Participating site
Site recruitment status and associated date for abstracted trial sites. Refer to Recording Trial Statuses.
Status dates
Changing the overall trial status must reflect changes to the trial status at the site. For example, if you change the overall status from
Approved to Active, you must change the recruitment status from Not Yet Recruiting to Recruiting.
Trial documents
Documents you upload when using the Update Trial feature do not overwrite existing documents.

You can change the trial status information directly from the Search Results table without having to open the trial record. To use this method, in the Search
Results table's Action column, select Change Status and make your changes as per the instructions in Recording Trial Statuses.
To open the trial record for editing, refer to Updating Trial Information.

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Examples of Protocol Document Updates
The Update Trial feature accommodates the following type of protocol document changes.
Editorial, Administrative Changes (correction of minor typographical errors; clarifications made to previously approved descriptions of research)
Data, Data Collection, and Data Collection Materials (revised study diaries; revised questionnaires or QOL surveys given to participants)
Recruitment of Subjects (changes in the way subjects are recruited; a new or revised advertisement)
Principal Investigator Contact Information
To open the trial record for editing, refer to Updating Trial Information.

69

Updating Trial Information
How to Update Trials
1. Click Search > Clinical Trials. The Search Trials page appears.
2. Click Search > My Trials. The Search Results table displays the results of your search and actions available (if any) for each record. For
information about navigating the search results list, refer to Viewing Trial Details.

Available Actions column - Select Action list for Complete trials

Available Actions column - Select Action list for Industrial trials
3. In the Available Actions column, click Select Action > Update. The Update Trial page displays the data currently registered with CTRP.

Update Trial page for Complete trials

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Update Trial page for Industrial trials
4. Make changes to the fields as necessary. The system requires you to provide information for all fields marked with an asterisk (*). The
instructions are the same for trial registration and trial update, with some exceptions:
If applicable, enter a ClinicalTrials.gov ID, and then click Add ClinicalTrials.gov Identifier.
You cannot change the ClinicalTrials.gov ID once you have added it. Also, if the trial record already has a ClinicalTrials.gov
ID, you cannot change it. If the ClinicalTrials.gov ID specified for a trial is incorrect, contact the CTRO at [email protected].
gov.

When you submit the trial, the system checks the NCT number you entered to ensure that no other registered trial has the
same one. The system displays an error message if it finds another trial with the same NCT number. If this occurs, check the
number you entered and try again. If you are certain that the number you entered is correct, contact the CTRO at NCICTRO@
mail.nih.gov.

An asterisk ( * ) at the end of a trial title indicates that the trial has alternate titles.

71

To view the alternate titles, click the asterisk ( * )

A trial can accumulate program codes from different organization families. For example, a participating site might belong to a different
organization family than the lead organization. When you update a trial, the Program Code field displays all codes from the master list for
the organization family of the lead organization.
Primary Completion Dates are optional for non-interventional trials and for DCP trials. In both cases, the system excludes such trials
when submitting XML documents to ClinicalTrials.gov. Otherwise, Primary Completion Dates are required.
If appropriate, upload any new or updated documents. For instructions, refer to Uploading Trial-Related Documents. If you upload an
IRB document, the CTRO reviews the updated record you submit and makes changes to the record as necessary. For example, if you
upload an IRB document for a trial currently in the In Review state, the CTRO updates the IRB information section of the trial record (e.
g., IRB status and approval number).
For instructions on recording each field otherwise, refer to Registering New Trials.
5. To review the information you provided, click Review Trial. The system checks the updated information for errors, and displays the results at the
top of the Update Trial page.
6. If necessary, correct any errors, and click Review Trial. Repeat this cycle until your update is error-free.
7. Submit the trial update. The system sends you an update notification — with the details of what has changed — whenever you update accepted
trials.

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Updating Trial Statuses
You can update trial statuses for the trials you own without having to update other trial details.
Updating trial statuses from the Search Results table
After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to open the
trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change Status.

Errors and Warnings
The system validates each new status as you add/update it. The system also validates each new status when you review the trial information
(as described in Reviewing and Submitting Trial Updates) before submitting the update.
If you add a status that does not conform to the rules provided in Status Transition Rules, the system displays errors and/or warnings.
For example, if you add the status Closed to Accrual the system warns you that both the status In Review and Approved are missing. Because Warnings
indicate that fixing the record is optional, you do not have to add the indicated statuses. However, Errors indicate that you must record the missing status
(in this case, Active) in order to submit the trial for registration

How to Update Trial Status Information
1. Search for the trial whose status information you want to update. For instructions, refer to Searching for Trial Records. The Search Results table
displays the results of your search and actions available (if any) for each record.

73

2. In the Available Actions column, click Select Action > Change Status, or if you want to update other aspects of the trial coincidentally, click Upd
ate.
The Update Trial Status window displays Trial Status fields and lists the previously-recorded trial statuses in the Trial Status History section.

3. Edit or add a new status as necessary. (For instructions, refer to Recording Trial Statuses.) If you changed the status to Administratively Complete
, Withdrawn, or Temporarily Closed, enter the reason for the status change.
The system does not change the status of participating sites when you close a trial.

4. To display comments about previous changes to trial status records, hover your cursor over the Comment icon.
Comments appear in a pop-up message.

Errors and Warnings
The system validates each new status as you add/update it. The system also validates each new status when you review the trial
information (as described in Reviewing and Submitting Trial Updates) before submitting the update.
If you update or add a status that does not conform to the rules provided in Status Transition Rules, the system displays errors and/or warnings. W
arnings indicate that fixing the record is optional, you do not have to add/update the indicated statuses. However, Errors indicate that you must
record the missing status in order to update the trial.

74

If you update a trial registered prior to the CTRP v4.2 release, the Trial Status History records may contain errors and warning as shown below.
You must correct each of the errors before you can update the trial.

The system refreshes the Trial Status History records as shown below. After you correct the errors, you can add/update a new status record.
5. Click Review Trial.
If the system detects errors and/or warnings, it prompts you to correct them. You cannot update the trial until you have corrected all errors.

6. Fix any errors as necessary. (For instructions, refer to Recording Trial Statuses.) Then click Review.
7. Click Submit.

75

Updating Trial Dates
The trial status dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Status Rules for
Trial Dates.
You can update trial start/completion dates for trials you own without having to update other trial details.
Updating trial statuses from the Search Results table
After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to open the
trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change Status.

How to Update Trial Dates Section
1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates
a required field.
2. Indicate whether the dates you entered are Actual or Anticipated.

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Updating Participating Site Statuses in Complete Trials
The Update Participating Sites section captures site statuses and dates. When updating sites, you must follow the the rules specified in Status Transition
Rules.
For Abbreviated trials, refer to Updating Participating Site Organization Records.
Errors and Warnings
The system validates the trial and site status transition(s) you make to each participating site when you review the trial information (as described
in Reviewing and Submitting Trial Updates) before submitting the update.
If you add a status that does not conform to the rules provided in Status Transition Rules, the system displays errors and/or warnings. Warnings indicate
that fixing the record is optional. However, Errors indicate that you must correct the site status and/or status date.
How to Update Participating Site Status Information
1. Search for the trial whose participating site status information you want to update. For instructions, refer to Searching for Trial Records. The
Search Results table displays the results of your search and actions available (if any) for each record.

2. In the Available Actions column, click Select Action > Update. The Update Trial window lists the previously-recorded participating site statuses
in the Participating Sites section.

3. Select new statuses and enter dates as necessary.

4.

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4. Click Review Trial.
If you entered invalid values, error messages display instructions for correcting the statuses and/or dates.

5. Fix any errors as necessary, and then click Submit.
The system does not change the status of participating sites when you close a trial.

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Reviewing and Submitting Trial Updates
After you have completed updating the trial, review the information for errors and edit any details that do not match the changes in your change memo or
other source. You can print a copy of the Update Trial pages to facilitate the review and/or keep for your records.
How to Review and Submit Trial Updates
1. Complete all modifications to the most recent trial submission.
2. Scroll to the bottom of the Update Trial page, and click Review Trial. The system checks for errors and missing information and displays the
results in a message at the top of the Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to
submit the trial.
3. Correct any errors if indicated, and repeat the previous step as many times as necessary until the update is error-free.
The Review Trial Details page is read-only. To edit information that you have reviewed, refer to Editing Updated Details.

4. Consider printing a copy of the updated trial to facilitate the review and/or keep for your records. Scroll to the bottom of the Review Trial Details
page, and click Print.
5. Click Submit.

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Printing Updated Trial Information
You can print a copy of the updated trial to facilitate the review and/or keep for your records. You must review the trial update in order to access the print
feature. For instructions on reviewing the trial, refer to Reviewing and Submitting Trial Updates.
How to Print Updated Trial Information
1. Review the updated trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.

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Editing Updated Details
You can edit your updated trial details after you have reviewed them at any time before you submit them to the CTRP.
How to Edit Updated Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit. The Update Trial page displays all information you have provided, in editable
form.
2. Make changes as necessary and then review the trial again. For instructions, refer to Reviewing and Submitting Trial Updates.

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Adding Your Site to Abbreviated Trials
This section provides instructions for adding your affiliated organization and its family members as participating sites in Abbreviated trials.
You can use the Add My Site feature to add your site to eligible trials one at a time. Site Administrators can use the Add Sites feature when adding their
sites or family member organizations to multiple trials, or add multiple participating sites to the same trial.
Before you begin, review your CTRP user account information and verify that you have indicated your current organization affiliation. For
instructions, refer to Requesting Organization Admin Rights.
For instructions, refer to the following pages:

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Using the Add My Site Feature
You can add your organization as a participating site to any Abbreviated trial that meets the following criteria:
(To add your organization as a participating site to a Complete trial, contact the lead organization.)
Trial Attribute

Requirement

Lead Organization

Not an organization in RSS

Your Organization

Not currently participating in the trial

Trial Processing Status

Accepted or beyond

Once added, you can update your site's record at any time.
Trial information that you can update after adding your site includes the following:
Organization's local trial identifier
Site principal investigator
Organization family's program codes
Site recruitment status and dates
How to Add Your Organization as a Participating Site
1. Select the trial that your site is participating in. The Available Actions column in the search results table displays actions currently available for
the trial.
2. In the Available Actions column, click the Select Action button and click Add My Site. The Add Participating Site page appears. The
Participating Site list contains all organizations in the Organization Family associated with your CTRP account.
3. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page appears.
4. In the Local Trial Identifier field, enter the identifier used at the participating site.
5. Next to the Site Principal Investigator field, click Look Up to search for and select the site principal investigator.
6. (Optional) Specify a contact for the trial at this participating site. You can do so in one of the following ways:
Next to the Site Primary Contact field, click Look Up to search for and select the site primary contact.
Next to the Generic Contact field, click Look Up Generic Contact to search for and select a CTRP person record.
7. (Optional) Consider whether the default contact information for the selected person record is appropriate for the trial at this participating site. The
system accepts either the contact’s primary telephone number or the contact’s primary email address. You can provide both if available. Enter
the phone number in the format 123-456-7890. You can provide an extension if available.
8. (Optional) In the Program Code field, select one or more program codes for the trial. The Program code field lists all program codes available for
the organization family.
9. Add site recruitment status information:
a. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*)
indicates a required field.
Field
Site
Recrui
tment
Status
Date*

Description/Instructions
Enter the date on which the current trial status became effective.
To ensure that you record valid status dates, review the information provided in Status Rules for Trial Dates.

Select the current stage or state of the trial or study.
Site
Recrui
tment
The system validates all status transitions when you save a status record. If you add or update a status transition
Status*
that does not conform to the rules provided in Status Transition Rules, the system displays errors and/or
warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions.
However, Errors indicate that you must resolve the transitions by correcting trial status records.

b. Click Add Status. The Site Recruitment Status History section appears, displaying the site recruitment information you entered.
c. Repeat the process of entering a status date, entering a status, and clicking Add Status until you have entered all statuses for the site.
10. If the system displays Errors or Warnings indicating that the status you added is invalid, do one of the following.
a. To edit the status, in the Actions column, click the Edit icon. Then, in the Edit Trial Status dialog box, make changes as indicated in
the Error and/or Warning message.
b. To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record.
Then add the correct status information.
12. Click Save. Your information is added to the trial details.

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Viewing Participating Sites
You can view a list of organizations that are participating in a trial whether or not you are the trial owner or submitter.
How to View Participating Sites
1. Search for the trial of interest.

2. In the trial record's Participating Sites column, click View.
The View Participating Sites page displays a list of organizations that are currently participating in the trial.

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Updating Participating Site Organization Records
Keep in mind the following about the representation of NCI-designated Cancer Centers in CTRP:
A CTRP organization family represents an NCI-designated Cancer Center family of organizations. For brevity, this guide refers to this entity as a
Cancer Center family.
A CTRP organization that is a member of a Cancer Center family is considered a Cancer Center organization. For brevity, this guide refers to this
entity as a Cancer Center organization.

If you are affiliated with a Cancer Center organization that has been added to a trial as a participating site, the following points indicate whether you can
update that participating site:
If you added an organization as a participating site to a trial, you will be the participating site record owner and can update information about that
organization in the same trial record.
If you are affiliated with an organization and that organization is a participating site on a trial, you can update information about that organization
in the same trial record.
If you are a Site Administrator and your affiliated organization is in a Cancer Center family, you can update your organization's sibling sites on a
trial(that is, other participating sites in the Cancer Center family).
If you are not a Site Administrator and are affiliated with a Cancer Center family, you must request Site Administrator privileges from your Site
Administrator before you can update any organization that is a participating site in the family. For directions on how to grant or revoke Site
Administrator privileges click here.
For information about appointed participating site records, see Managing Trial Ownership.

How to Update Participating Site Organization Records
1. Search for the trial that you are participating in by following the instructions in Searching for Trials.
2. In the Available Actions column, click Select Action > Update My Site.

The Update Participating Site page displays family member sites available for update.

3. From the Participating Site drop-down list, select the site you want to update.

4.

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4. Click Submit. The Update Participating Site page appears. The Organization Name field is pre-populated with the organization you selected on
the previous page.

5. Enter the new information in the fields as appropriate.
6. If the system displays Errors or Warnings, follow the instructions in Using the Add My Site Feature to edit or delete the records.
7. Click Save. Your information is updated.

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Registration Site Administration
This page tree provides instructions for Site Administrators. A Site Administrator is a user with administrative privileges who is responsible for:
Assigning Site Administrator status to other users in the organization
Reviewing and updating user access to trials associated with the organization
Authorizing users to submit subject accrual data for trials that have been fully abstracted and verified
Adding participating sites to Abbreviated trials
Managing the set of program codes and program code assignments for the organization family
Managing targeted accrual, the total number of participants expected to accrue at all of the sites within your organization family participating on a
study.
This page tree introduces you to site administration management and provides instructions for these tasks.
Each organization registered in the CTRP system can have more than one site administrator. You can request primary site administration authority from
the CTRO. For instructions, refer to Requesting Organization Admin Rights.

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Granting and Revoking Administrative Rights
The Site Administrator for a site is the CTRP user with the following qualities:
The CTRO or another Site Administrator has granted the user profile the administrative rights.
The user profile is affiliated with that site (an organization family or a single organization that does not belong to an organization family).
The relationships between Site Administrators and trials in a single site are as follows:
An organization:
Can have one original Site Administrator.
Can have many Site Administrators appointed by the original Site Administrator.
Can be the lead organization for many trials.
Can be the affiliated organization for many users who can submit and own trials.
A trial:
Can have one submitter.
Can have one organization affiliation, defined by the lead organization.
Can have many trial owners.
Trial ownership:
Can be implicit. By default, if a Site Administrator's affiliated organization is the lead organization for a trial, that Site Administrator is an
implicit owner of that trial.
Can be explicit. By default, the trial submitter is the only explicit trial owner. A Site Administrator can grant ownership of a trial to more
users and can remove trial ownership from the original submitter and other users. (Refer to Managing Trial Ownership.) If you add a Site
Administrator as an owner of a trial, that Site Administrator has explicit ownership of that trial, rather than just implicit ownership.
A Site Administrator can do the following:
Display trial ownership
Manage trial ownership
Manage site record ownership
Manage accrual access
Manage the administrative rights of other users in the organization
Revoke own administrative rights

Site administrators do not receive system-generated emails automatically
The system sends generated emails (including TSRs) to a Site Administrator only if the Site Administrator's affiliated organization is the trial's
lead organization, or if the Site Administrator is the trial submitter and/or trial owner. The Site Administrator can also manage email notification
globally. For instructions, refer to Managing Registration Email Notifications.
As a Site Administrator, you can grant and revoke administrative rights to other users in your organization. (You can grant/revoke administrative rights to
users who have a CTRP account and whose organizational affiliation is the same as your own.) Site Administrators are the only Registration users who
can access the Site Administration menu.
How to Grant and Revoke Site Administrative Rights
1. On the toolbar, click Administration > Site Administration. The Site Administration page appears, listing Registration users and indicating which
ones have previously been granted administrative rights.

2. Search for the Registration user for whom you want to adjust administrative rights: Specify the user by first name, last name, or email address,
and then click Search. The user's name appears in the Search Results list.
a. To promote the user to Site Administrator, select the check box in the Allow as Site Admin? column.

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2.
a.
As a Site Administrator, you can revoke your own administrative rights. Use caution if you do so because you can not promote
yourself thereafter.
b. To revoke administrative access, clear the check box in the Allow as Site Admin? column.
3. Click Save.

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Assigning and Unassigning Accrual Access
Site Administrators can authorize users to submit subject accrual data for trials that have been fully abstracted and verified. Once assigned, users can
submit accrual data for all trials associated with their affiliated organization or organization family members. For Complete trials (National, Externally PeerReviewed, or Institutional), the organization must be a lead; for Abbreviated trials (Industrial or Other), the organization must be a participating site.
Assignment at the organization level pertains to trials that the organization has registered in CTRP and extends to those that it will register in the future. Si
milarly, assignment at the organization family level pertains to trials that any member organization has registered in CTRP and extends to those that it will
register in the future.
Only the CTRO has access to CTEP and DCP trial accruals.

The table below outlines the access and trial assignment rules for Complete and Abbreviated trials.
Access/Assignment
Who can assign
access?

Complete Trial

Abbreviated Trial

A registered user logged in as the lead organization's Site Administrator for any trial other
than DCP or CTEP trials
Super Abstractor for DCP and CTEP trials

A registered user
logged in as Site
Administrator for any
trial other than DCP or
CTEP trials
Super Abstractor for
DCP and CTEP trials

To whom can you
assign access?

Any registered user affiliated with the Site Administrator's organization, or family member
organization (including the Site Administrator)

Any registered user
affiliated with the assigner's
organization (including the
Site Administrator)

What types of trials
can you assign?

Complete trials for which the assigner's organization is the lead organization

Abbreviated trials for which
the assigner's organization
is the lead organization or
participating site

How can you assign
access?

By trial
By organization
By organization family member

By trial
By participating site

The system automatically assigns the organization family Accrual Submitter access to any trial
registered by new organizations added to an organization family in the future. It withdraws
access if anyone removes the organization family Accrual Submitter's organization from the
organization family in the future.
Who can submit
accrual data?
To which trials can the
organization family
Accrual Submitter
submit accrual data?

Any assigned user affiliated with the lead organization, or with a lead organization that is a
member of the user's affiliated organization family
All Complete trials registered by the submitter's organization or family member
organization
Trials currently registered in CTRP
Trials that the organization registers in CTRP in the future, once abstracted

For instructions, refer to the following pages:

90

Any assigned user affiliated
with the participating site
All Abbreviated
trials registered by the
submitter's
participating site only
Trials currently
registered in CTRP
Trials that the
organization registers
in CTRP in the future,
once abstracted

Assigning and Unassigning Accrual Access by Trial
As a Site Administrator, you can assign a user accrual access to any trial that the user submitted to the CTRP or currently owns. You can assign specific
trials to specific users.
1. On the toolbar, click Administration > Accrual Access > Manage. The Manage Accrual Access page appears.

2. Select Assign user access to individual trials.
3. From the Select a user list, select the user to whom you want to assign or unassign accrual submission privileges. The list of trials available for
accrual submission for the user you selected appears in the Not Assigned list on the left side of the page, and trials to which access had
previously been granted (if any) appear on the right.
To view the entire text of a trial's title, hover your cursor over the part of the title displayed.

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Trials in the Not Assigned list that have not been validated appear in grey text and are unavailable for selection.

4. In the Select a trial category list, consider narrowing the list of trials to a category.
5. From the Not Assigned trial list, select the trial to which the user should be able to submit accrual data, and then click the single arrow ( > ) under
Assign. Or, to assign all eligible trials, click the double arrow ( >> ).
You can select multiple trials
To select multiple trials, click one trial, then press and hold the CTRL (or CMD) key and click one or more additional trials. Then click
the single arrow ( > ) under Assign.
A Comments box appears.

6. Optionally, in the Comments box, enter a comment about this assignment, and then click Save.
Comments are optional. You can leave the comment field blank and still save the accrual assignment. To abort the assignment, click C
ancel instead.
A message confirms your assignment. The assigned trial(s) appear in the Assigned list.
7. To unassign access, from the Assigned trial list, select the trial you want to unassign, and then click the single arrow ( < ) under Unassign. Or, to
unassign all trials, click the double arrow ( << ).
8. Optionally, enter a comment in the comment box, and then click Save. The system moves the trial(s) you selected to the Not Assigned list, and
the user no longer has access to them.

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Assigning and Unassigning Accrual Access by Site
As a Site Administrator, you can assign a user accrual access globally by site. You can grant users rights to submit accruals for all trials in CTRP that have
been submitted or will be submitted by the affiliated site.
1. On the toolbar, click Administration > Accrual Access > Manage. The Manage Accrual Access page appears.
2. Select Make user a Site Submitter.

3. Select the user from the Select a user drop-down list.
4. To assign access, click Assign.
5. To unassign access, click Unassign.

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Assigning and Unassigning Accrual Access by
Organization Family
As a Site Administrator, you can assign a user accrual access globally by organization family. You can grant users rights to submit accruals for all trials in
CTRP that have been submitted or will be submitted by any site that is a member of the organization family.
1. On the toolbar, click Administration > Accrual Access > Manage. The Manage Accrual Access page appears.
2. Select Make user an Org Family Submitter.

3. Select the user from the Select a user drop-down list.
4. To assign access, click Assign.
5. To unassign access, click Unassign.

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Viewing Accrual Assignment History
As a Site Administrator, you can view a history of the trials associated with your organization, to which users have been assigned/unassigned user access.
1. On the toolbar, click Administration > Accrual Access > Assignment History. The Accrual Assignment History page lists all access
assignments.

2. To navigate the table, refer to Working with Tables and Search Results.
3. To export the assignment history to a file, click CSV (comma-separated values) or Excel in the bottom left corner. Your browser prompts you to
open or save the file.

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Viewing Accrual Assignment History by Trial
As a Site Administrator, you can view a history of your organization's accrual access assignment on a per-trial basis.
1. On the toolbar, click Administration > Accrual Access > View. The Accrual Access Assignment by Trial page lists all current access
assignments by trial, grouped by trial category.

2. To navigate the table, refer to Working with Tables and Search Results.
3. To export the assignment history to a file, click CSV (comma-separated values) or Excel in the bottom left corner. Your browser prompts you to
open or save the file.

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Managing Trial Ownership
You can review and update user access to trials associated with the organization. For instructions, refer to the following pages:

97

About Trial Ownership
As a Site Administrator, you can assign and unassign trial ownership rights to multiple users in your affiliated organization and its family member
organizations, and multiple trials at the same time. (Trials displayed on the Manage Trial Ownership page are those that you have submitted or those
submitted by users if the trial's lead organization is the same as your affiliated organization or its family member organizations.)
For example, you can grant ownership of one trial to three CTRP users within your organization. Or, you can grant one user ownership of three trials.
Additionally, you can tell the system to send notifications about the trial(s) via email to the owners you assign.
Users must have a CTRP account, complete with organizational affiliation, in order for you to grant them trial ownership.

For Abbreviated trials, owners are responsible for updating their affiliated organization's information on trials in which their site is a participant, using the
Update My Site action. Owners can update the following information:
Organization family's program code
Organization's local trial identifier
Site principal investigator
Site recruitment status and dates
Trial ownership requirements
In certain circumstances, you may not be able to change trial ownership using the Manage Trial Ownership functionality. For example, you may
not be able to change trial ownership if the trial status is Complete rather than Active, and the lead organization is not the trial submitter's
affiliated organization. (Refer to Recording Trial Statuses.) However, you can request trial ownership changes by contacting the CTRO at NCICT
[email protected]. When requesting trial ownership changes, include the new owner's first name, last name, and email address. Ensure that the
user has a valid CTRP account. For instructions, refer the user to Creating a CTRP Account.
The system stores your affiliated organization with your account information on the My Account page. Your affiliation determines which trials and which
users you can assign.

You can assign any trial submitted by your affiliated organization or its family member organizations. For example, if you are affiliated with the M D
Anderson Cancer Center, you can manage trial assignments for trials associated with the M D Anderson International and UF Cancer Center at Orlando
Health organizations. The following image lists the organizations in the M.D. Anderson Cancer Center organization family.
The organization must be a lead organization for Complete trials, or a participating site for Abbreviated trials.

98

99

Trial Ownership Example
The system associates trials with the user who last submitted the trial, and with the last submitter's affiliated organization.
For example, in the figure below, Isabelle Autissier (username = CTRPDOC1) submitted the trial while affiliated with M D Anderson. She is the last
submitter and trial owner. M D Anderson is the last submitter organization and associated with the trial.

The CTRP system identifies the trial by the last submitter and the last submitter organization. In the figure below, username CTRPDOC1 is affiliated with M
D Anderson as per the account information in the figure above.

If Isabelle Autissier changes her organization affiliation, the results depend on the extent of the change:
If she changes her organization affiliation to another within the organization family such as U.T. M.D Anderson Cancer Center after having
submitted the trial, she retains trial ownership and her original organization retains association with the trial.

If she changes her organization affiliation to an organization outside the organization family such as Vanderbilt-Ingram Cancer Center, she loses
trial ownership of all trials affiliated with M D Anderson. Her trial will not be among the "Search My Trials" results. M D Anderson Cancer Center
retains association with the trial; Vanderbilt-Ingram Cancer Center does not assume association with the trial despite the last submitter's new
organization affiliation.

The example above involves Complete trials. The same principles apply to Abbreviated trials, but changes in affiliation affect association with
the site record rather than association with the trial.

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Assigning Trial Ownership
How to Assign and Unassign Trial Ownership
1. On the toolbar, click Administration > Trial Ownership > Manage. The Manage Trial Ownership page displays the following lists:
At the top of the page: The names of users affiliated with your affiliated organization or its family member organization(s).
Below the list of names: Trials on which your organization is a lead organization or participating site.

2. Under Manage trial record ownership for, select which role your affiliated organization or its family member organization(s) play(s).
a. For Complete trials, select Lead Organization.
b. For Abbreviated trials, select Participating Site.
3. Indicate which users you want to give the ability to update and amend selected Complete trials; or update Abbreviated trials. To do so, select one
or more user names on the list.
You can select or deselect all names, or filter the list of names
To select all names, select the check box on the left side of the column heading. Click it again to deselect all names.

To filter the list of names, in the Search field, type one or more characters contained in a user's name or email address. The system
filters the list as you type each character.
4. In the list of trials at the bottom of the page, under All Available Trials, or All Available Abbreviated Trials, select the trials to assign to the user
(s), and then click the Assign icon ( > ).

5. To unassign trials, under Trial Ownership Assignments, or Site Owner Assignments, select the user(s) you want to unassign, and click the
Unassign icon ( < ).
6. For Complete trials, indicate which trial owners should receive email notifications about the trial(s):
To indicate that a specific user should or should not receive email, in the Email Notification? column, in the row for that user, click Yes
or No.

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To indicate that all owners should or should not receive email, in the Email Notification? column header, click All > Select Yes/No for
all.

The Select No for All and Select Yes for All options apply globally to all trial owners, not just the ones currently visible in the
list.

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Displaying Trial Ownership
You can perform the following tasks on the trials you own:
View trial details
Update trials
Amend Complete trials
Access TSR and XML documents
As a Site Administrator, you can display trial ownership for any trial for which your organization or its family member organization is the lead organization.
Additionally, you can indicate whether a user would like to receive system notifications, including TSRs and XML files, on a trial-by-trial basis.
How to Display Trial Ownership
1. On the toolbar, click Administration > Trial Ownership > View. The Display Trial Ownership page displays the current owner(s) of the trials for
which your organization is the lead organization. It also indicates which of the owners, for each of the trials, receive system-generated email
notifications.

2. You have the following search options:
To display all the trials owned by a given user, search for the user by first name, last name, or email address, and then click Search. The
system lists all trials owned by the user in the Search Results list.
To display all owners of a given trial, enter the NCI Identifier in the field provided, and then click Search. The system lists all owners of
the selected trial in the Search Results list.
3. You have the following options to manage trial ownership:
Indicate whether or not an owner of a trial should receive system-generated email messages. To do so, in the Receive Email? column,
select Yes or No.
Selecting Yes indicates that you want the owner to receive all notifications regarding the specified trial.
Selecting No indicates that you do not want the owner to receive any notifications regarding the specified trial.
To revoke ownership of a trial, locate the user/trial in the Search Results list, and then click Remove.
4. You have the following additional options:
To filter the search results, in the Search field, type one or more characters contained in any of the fields. The system filters the list as
you type each character. For details, refer to Working with Tables and Search Results.
To create more space on the page, on the upper right corner of the page, select the Hide Search Criteria check box.

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Adding Sites
As a site administrator, you can add participating sites as follows:
Add your site to multiple Abbreviated trials
Add a Family Member Organization as a participating site to multiple Abbreviated trials
Add multiple Family Member Participating Sites to a given trial
The system does not allow duplicate sites on trials.

How to Search for the Trials to which You Want to Add Participating Sites
1. On the toolbar, click Register Trial > Add Sites. The Search Trials page appears.
2. Enter a trial identifier (NCI, lead organization, or other) or enter all or part of a trial title.
3. Click Search. The system lists in the results table the Abbreviated trials with which your affiliated organization or its family members are not yet
participating.
The system can return up to 100 trials. If the system finds over 100 records in the database, it prompts you to narrow your search
criteria.
4. Optionally, to sort the results, click the column ascending or descending arrows. This option is available only prior to adding your first site.
How to Add Organizations as Participating
1. On the toolbar, click Register Trial > Add Sites, and search for the trials to which you can add participating sites as described above.
The Abbreviated trials with which your affiliated organization or its family members are not yet participating are listed in the results table.
2. In the row of the trial to which you want to add sites, click the Plus sign (
). The trial record expands to display trial information. The Site field is
pre-populated with your affiliated organization automatically.
For an Abbreviated trial where the participating site you are adding is a member of a cancer center family, the Program Code(s) field is available.
The Program Code field lists all program codes available for that organization family.
3. Optionally, in the Program Code(s) field, select one or more program codes for the trial.
4. If you need to change the participating site, select one from the Site drop-down list. Only your family member organizations are listed.
5. If the Principal Investigator has not been selected, click the Look Up Person icon (
) and search for the investigator.
6. Enter the Local Trial Identifier.
7. (Optional) If the trial record does not already specify a contact for the trial at this participating site, you can do so in one of the following ways:

8.

9.
10.
11.

Next to the Site Primary Contact field, click the look up person icon to search for and select the site primary contact.
Next to the Generic Contact field, click the look up person icon to search for and select a CTRP person record.
(Optional) Consider whether the default contact information for the selected person record is appropriate for the trial at this participating site. The
system accepts either the contact’s primary telephone number or the contact’s primary email address. You can provide both if available. Enter
the phone number in the format 123-456-7890. You can provide an extension if available.
Select the Site Recruitment Status and the Site Recruitment Status Date. Click Add Status. The status record appears in the Site
Recruitment Status History list.
If your organization belongs to a family, you can add to this trial any site within that family. To add another site to the same trial, in the Site
column, click Add Another Site, and repeat the steps above to complete the trial/site information.
Scroll to the bottom of the page and click Save.

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Managing Data Table 4 Information for Your Center
As a Site Administrator, you can manage Data Table 4 information for your organization family. You can manage this information for trials that meet all of
the following criteria:
Complete trials where a member of your cancer center family is the lead organization on the trial and/or a member of your cancer center family is
a participating site on the trial.
Abbreviated trials where a member of your cancer center family is a participating site.
Trials with status other than Withdrawn.
Trials with processing status other than Rejected or Submission Terminated.
Trials that were active during the cancer center reporting period.
Keep in mind the following points about the entities in CTRP that represent NCI-designated Cancer Centers:
A CTRP organization family represents an NCI-designated Cancer Center family of organizations. For brevity, this guide refers to this entity as a C
ancer Center family, a Cancer Center, or an organization family.
A CTRP organization that is a member of a Cancer Center family is considered a Cancer Center organization. For brevity, this guide refers to this
entity as a Cancer Center organization.
For instructions, refer to the following pages:

105

Managing Targeted Accrual
If you are a Site Administrator, you can add the total number of participants expected to accrue at all of the sites within your organization family
participating on a study. You can add this information to the trials described in Managing Data Table 4 Information for Your Center.
1. On the toolbar, click Administration > Manage DT4 Information > Manage DT4 Information for Your Center. A page by that name appears.
2. In the row for the trial of interest, in the Targeted Accrual for Your Center column, specify the targeted accrual:
a. Click the existing value (or Empty). A text box appears.

b. Change the value or enter a new one. When done, click the check mark. The system saves your changes.
This value appears in the Your Center Total column of the Data Table 4 report. For instructions on generating that report, refer to Running CTRP Data
Table 4 Reports.

106

Managing Program Codes
Each cancer center family uses program codes to group its clinical trials. As a Site Administrator, you can manage the set of program codes and program
code assignments for your organization family. You can assign program codes to the trials described in Managing Data Table 4 Information for Your Center.
For instructions, refer to the following pages:

107

Viewing Program Codes
1. On the toolbar, click Administration > Manage DT4 Information > Manage Program Code Master List. The Manage Program Codes Master
List appears.

2. Notice that this page displays information specific to your organization family.
Note Visible to Internal Users Only
Internal users with the Program Code Administrator role: From the Organization Family list, select an organization family. You can perform
all of the functions available to a site administrator at the family you select.

You can navigate through the list of program codes just like any other list of search results in the CTRP Registration application. For instructions, refer to W
orking with Tables and Search Results.

108

Adding Program Codes
1. On the Manage Program Codes Master List page, in the Program Code field, enter a unique program code. This is likely to be a very short
representation of the program.

2. (Optional) In the Program Name field, enter a program name.
3. Click Add Program Code. The new program code appears in the list.
For each organization family, active program codes must be unique. The list may contain two entries with the same program code, if one is active and the
other is inactive.

109

Editing Program Codes
When you change a program code, the system re-assigns to the new program code all trials (including closed trials) currently assigned to the old program
code.
1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the Edit icon (
Code dialog box appears.

). The Edit Program

2. Change the program code, program name, or both.
3. Click Save.
If you have changed only the program name, the list reflects your change.
If you have changed the program code, a confirmation message appears. If you want to proceed, click Yes. The list reflects your change.

110

Deleting or Inactivating Program Codes
1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the Delete icon (
). The system checks
whether the selected program code has been assigned to any trials. What happens next depends on the result of that system check:
If the selected program code has not been assigned to any trials, then a message appears, asking you to confirm the deletion.

Otherwise, a dialog box appears with details, asking you to confirm the inactivation.

2. After reading the provided information, confirm or cancel the action:
To confirm deletion, click Delete. To confirm inactivation, click Yes. The list changes to reflect your action:
If you deleted a program code, the system removes the program code completely.
If you inactivated a program code, the system removes the program code from only trials that were active at any time during the
reporting period. (For instructions on changing the reporting period, refer to Viewing the Assignments for a Program Code.) You
can no longer assign this program code to trials. For trials with this program code outside of the reporting period, the system
appends “-inactive” to the program code.
To cancel deletion, click Cancel. To cancel inactivation, click No.

111

Viewing the Assignments for a Program Code
1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the View icon (
). The Manage DT4
Information for Your Center page appears.
2. Notice that this page displays information specific to a date range:
The default end date is 12/31/2015. In the Reporting Period End Date field, consider specifying a different date.
The default reporting period length is 12 months. In the Reporting Period Length field, consider specifying a different number.
3. Notice that this page displays a list of trials that meet all the following criteria:
Trials in which any member of your organization family is a participant.
Note Visible to Internal Users Only
Internal users with the Program Code Administrator role: From the Organization Family list, select an organization family. You can
perform all of the functions available to a site administrator at the family you select.

Trials assigned the program code that you selected on the Manage Program Codes Master List page.
Trials with any of the following statuses at any time within the reporting period, as specified on this page:
In Review
Approved
Active
Enrolling by Invitation
Temporarily Closed to Accrual
Temporarily Closed to Accrual and Interventions
4. If you want to adjust the list filter, instructions depend on whether the list is already filtered:
a. If the list has been filtered, in the Program Code(s) column header, click the button that indicates the number of program codes
selected. The list includes all program codes for the organization family and other options.
b. If the list has not been filtered yet, in the Program Code(s) column header, click the filter icon (
). The Select Program Code(s) button
appears. Click Select Program Code(s). The list includes all program codes for the organization family and other options.
5. Select one or more program codes from the list. (To select all program codes or deselect all program codes, toggle the Select/Deselect All
option. To display trials that have not been assigned to program codes, select None.) The system updates the list of trials to reflect your
selections.
You can navigate through the list of trials just like any other list of search results in the CTRP Registration application. For instructions, refer to Working
with Tables and Search Results. On the Manage Program Code Assignments page, in the Search box, if you include the search term in double quote
marks (for example "cancer"), the search results include trials that have an exact match in any of the first five columns.

112

Assigning a Program Code to a Single Trial
1. On the Manage DT4 Information for Your Center page, in the row for the trial of interest, in the Program Code(s) column, click the v icon.

The Program Code field appears.

2. Click the Program Code field. The list includes all program codes for the organization family, but the ones already assigned to the selected trial
are unavailable for selection.
3. Select the target program code. The Program Code(s) column reflects your changes.
You can also assign a program code to a trial while performing the following tasks:
Registering, amending, or updating a Complete trial. For instructions, refer to Registering New Trials, specifically Recording Data Table 4
Information.
Adding your site after importing a trial. For instructions, refer to Registering Abbreviated (Industrial and Other) Trials.
Adding a participating site to an Abbreviated trial or updating such a site (as a site affiliate). For instructions, refer to Adding Your Site to
Abbreviated Trials.
Adding participating sites to Abbreviated trials (as a Site Administrator). For instructions, refer to Adding Sites.

113

Unassigning a Program Code from a Single Trial
On the Manage DT4 Information for Your Center page, in the row for the trial of interest, in the Program Code(s) column, click the x for the program
code you want to unassign. The Program Code(s) column reflects your changes.

You can also unassign a program code from a trial while performing the following tasks:
Amending or updating a Complete trial. For instructions, refer to Registering New Trials, specifically Recording Data Table 4 Information.
Adding a participating site to an Abbreviated trial or updating such a site (as a site affiliate). For instructions, refer to Adding Your Site to
Abbreviated Trials.
Adding participating sites to Abbreviated trials (as a Site Administrator). For instructions, refer to Adding Sites.

114

Assigning Program Codes to Multiple Trials
1. On the Manage DT4 Information for Your Center page, select one or more trials of interest.
2. Click Assign (at the bottom of the page). The Assign Program Codes dialog box appears. The list includes all program codes that you can assign
to the selected trials.

3. In the list, select one or more target program codes.
4. Click OK. The Program Code(s) column reflects your changes.

115

Unassigning Program Codes from Multiple Trials
1. On the Manage DT4 Information for Your Center page, select one or more trials that have been assigned to program codes.
2. Click Unassign (at the bottom of the page). The Unassign Program Codes dialog box appears with a list of all program codes, but only the ones
assigned to the selected trials are available for selection.

3. In the list, select one or more program codes.
4. Click OK. The Program Code(s) column reflects your changes.

116

Replacing a Program Code
1. On the Manage DT4 Information for Your Center page, select one or more trials that have been assigned to program codes.
2. Click Replace (at the bottom of the page). The Replace Program Code Assignments dialog box appears with two lists. The first list includes all
program codes assigned to any selected trial.

3. In the first list, select the program code that you want to replace. The second list includes all program codes for the organization family. However,
the one you selected in the first list becomes unavailable for selection in the second list.
4. In the second list, select one or more target program codes.
5. Click OK. The Program Code(s) column reflects your changes.

117

Viewing Your Participation
1. On the Manage DT4 Information for Your Center page, in the row for the trial of interest, in the Lead Organization column, click Show my
participation. The Participating Sites dialog box appears, listing only the participating organizations that are members of your organization family.

2. When you are done viewing the list of participating sites, click Close.

118

Specifying the Center Principal Investigator
If you are a Site Administrator, you can specify the Center Principal Investigator for the trials described in Managing Data Table 4 Information for Your
Center.
1. On the toolbar, click Administration > Manage DT4 Information > Manage DT4 Information for Your Center. A page by that name appears.
2. If you want to specify a different person, in the row for the trial of interest, in the Center Principal Investigator column, click Look Up. For
instructions, refer to Looking Up Registered Persons.
This value appears in the PI columns (Last Name, First Name, Middle Initial) of the Data Table 4 report. For instructions on generating that report, refer to R
unning CTRP Data Table 4 Reports.

119

Managing Local Trial IDs
If you are a Site Administrator, you can specify the local trial ID for each of the trials described in Managing Data Table 4 Information for Your Center.
1. On the toolbar, click Administration > Manage DT4 Information > Manage DT4 Information for Your Center. A page by that name appears.
2. In the row for the trial of interest, in the Local Trial ID column, enter your site's ID for the trial:
a. Click the existing value (or Empty). A text box appears.
b. Change the value or enter a new one. When done, click the check mark. The system saves your changes.
The system does not use the Local Trial ID column to generate the Data Table 4 Report. Field values will not be copied into the Center Local Trial ID field
(in Registration) of the Data Table 4 report. For instructions on generating that report, refer to Running CTRP Data Table 4 Reports.

120

Verifying Trial Data
NCI requires that trial owners, trial submitters, and members of the Clinical Trials Reporting Office (CTRO) staff verify their open trial records twice per year
to ensure that information is accurate and up-to-date.
This requirement applies to Interventional trials that have the following attributes:
Trial processing status is either Abstraction Verified - No Response or Abstraction Verified - Response
Trial status is anything other than the following:
Withdrawn
Administratively Complete
Complete
The system sends trial owners, trial submitters, and site administrators a verification reminder 30 and 15 days before their trial data verification
due dates. It sends reminders to CTRO staffs 7 days before the due date.
CTRO staffs are responsible for verifying the types of trials below. Trial owners and submitters are responsible for verifying all others.
NCI-managed trials (trials with DCP or CTEP IDs)
NCI-sponsored trials
Trials imported from ClinicalTrials.gov
Trials submitted by users affiliated with the National Cancer Institute or National Cancer Institute Division of Cancer Prevention
Trials submitted by the NCI Center for Cancer Research (CCR)

Each time you verify a trial, the CTRP system records your name and date of verification. This is true for original as well as updated trials. You can view
these records at any time, but cannot change them.
For additional instructions, refer to the following pages:

121

How to Access the Trial Data Verification Page
1. Search for the trial by the identifier noted in the email reminder you received, or use the Search My Trials feature.
2. In the Available Actions column, click Select Action > Verify Data.

The Trial Data Verification page appears.

An asterisk ( * ) at the end of a trial title indicates that the trial has alternate titles.

122

3. To view the alternate titles, click the asterisk ( * )

123

How to Verify Trial Data
1. On the Trial Data Verification page, under Add Data Verification Record, click Save Verification Record.
2. Confirm that you would like to save the record by clicking OK in the pop-up message.
The Trial Data Verification page displays all verification records to date.

124

Working With Persons and Organizations
This section provides instructions for looking up persons and organizations registered in the Clinical Trials Reporting Program (CTRP), and for adding new
persons and organizations to it.

For instructions, refer to the following pages:

125

Looking up Registered Organizations
The procedure for searching for an organization registered in the CTRP is the same throughout the application, whether you are searching for a lead
organization, funding source, or other role. You can enter a series of characters in any of the search fields (except the PO ID, which must be an exact
match) to narrow the search results.
How to Look Up Registered Organizations
1. Click the Search Organizations tab, or on the toolbar, select Search > Organizations.
The Search Organizations page appears.

2. Provide as much information as you can about the organization you are looking for. You can enter the Organization Identifier (PO ID) or Cancer
Therapy Evaluation Program (CTEP) Identifier. You must enter search criteria in at least one field. The PO ID you enter for your search criterion
must be exact and complete. That is, do not use partial IDs or wildcards.
3. Click Search.
The search results appear in a new tab.

To control which columns appear in your search results, click Choose Columns.
A list of the available columns appear. Clear the check boxes for those columns you do not want to display.

126

If the lead organization is not listed, you may have searched too narrowly (that is, you may have provided too much information about the
organization). If the list of results is very long and contains many organizations that are similar to the one you are searching for, you can narrow
your search by providing more information.
4. If the organization does not appear in the results table, do one of the following to modify your search:
a. To broaden your search so that more organizations are listed in the search results, delete one or more of your criteria. For example, if
you searched by part of the organization’s name, city, state, and zip code in your original search, you may want to search by state alone.
-or b. To narrow your search so that fewer organizations are listed in the search results, provide more about your organization. For example, if
you searched by state in your original search, you may want to search by city in addition to the state.
5. If you still don’t find your organization in the system, you can ask the CTRO to create the organization record. To do so, follow the instructions in R
equesting Creation of an Organization Record.
6. To link to an organization to the trial, click its PO-ID value.
The organization’s name you selected appears in the Family Name field.

127

Requesting Creation of an Organization Record
If an organization record that you need for trial registration does not seem to be in the CTRP system, you can request that the CTRO create one.
1. Contact the CTRO at [email protected] and provide the following information:
The organization's name
The organization's street address
The organization's city
The organization's state or province
The organization's country
The organization's phone number
The organization's email address
2. Wait for a response. After resolving the request, the CTRO will send you an email message.

128

Looking Up Registered Persons
The procedure for searching for the name of a person registered in the Clinical Trials Reporting Program is the same throughout the application, whether
you are searching for principal investigators, responsible parties, or other roles. To link a person to a role, you select the person's record from a list of
search results.
The procedure below uses the principal investigator role as an example. The same search criteria may not appear in all search windows
however.

Using wildcard characters ( % )
You can enter a series of characters in any of the search fields to narrow the search results, but do not use wildcards.
How to Look Up Registered Persons
1. Next to any field for a person, such as Principal Investigator, click Look Up Person.
The Select Principal Investigator page appears.

2. Provide as much information as you can about the person you are searching for, or, enter the Person/Organization (PO) ID or Cancer Therapy
Evaluation Program (CTEP) Identifier. You must enter search criteria in at least one field.
Searching by PO ID
The PO ID you enter for your search criterion must be exact and complete. That is, do not use partial IDs or wildcards.
3. Click Search.
The Select Principal Investigator window displays the results of your search.

Tip
If your principal investigator is not listed, you may have searched too narrowly (that is, you may have provided too much information
about the person). If the list of results is very long and contains many names that are similar to the one you are searching for, you can
narrow your search by providing more information. Refer to the Step below for instructions.
4. If your investigator was not listed, modify your search as follows:

129

4.

To broaden your search so that more names are listed in the search results, delete one or more of your criteria. For example, if you
searched by both first and last names in your original search, you may want to search by last name alone.
- or To narrow your search so that fewer names are listed in the search results, provide more information about your investigator. For
example, if you searched by last name only in your original search, you may want to search by first name as well.
5. If you still don't find your investigator in the system, you can ask the CTRO to create the person record. To do so, follow the instructions in Reques
ting Creation of a Person Record.
6. To associate a person with the role, scroll through the results list until you locate the principal investigator's record, and then click Select.
The investigator's name you selected appears in the Principal Investigator field.

130

Requesting Creation of a Person Record
If a person record that you need for trial registration does not seem to be in the CTRP system, you can request that the CTRO create one.
1. Contact the CTRO at [email protected] and provide the following information:
The person's first name (given name)
The person's last name (inherited name)
The person's email address
The person's city
The person's state or province
The person's country
The organization with which the person is affiliated
2. Wait for a response. After resolving the request, the CTRO will send you an email message.

131

Viewing Trial Summary Reports and XML Documents
This section provides instructions for viewing Trial Summary Reports (TSRs) and XML documents.
You can view the Trial Summary Report (TSR) for Complete trials you own.
The View TSR link is available even if the CTRO has not accepted the trial.

You can view the XML document for a trial you own if it meets the following criteria:
Trial category is Complete
Processing status is one of the following:
Abstraction Verified Response
Abstraction Verified No Response
On Hold (if the trial was put on hold after it reached either of the two statuses above)
How to View TSR and XML Documents
1. If you intend to use an XML file to upload your trial record from CTRP to ClinicalTrials.gov, make sure your trial record in CTRP has all of the trial
attributes required by ClinicalTrials.gov. For details on which attributes are required, refer to https://prsinfo.clinicaltrials.gov/definitions.html. If you
need to add or change any attributes in your trial, refer to the following pages or contact the CTRO at [email protected]:
Updating Trials
Amending Complete Trials
2. Search for the trial(s) for which you want to view a TSR or XML document.
The Submitted Clinical Trials Search Results table displays the trial(s) you searched for. Available actions are listed (if any) for each record.

3. In the Available Actions column, click Select Action > View TSR or Select Action > View XML.

132

Managing Your Account
This page tree provides instructions for modifying your CTRP account.

133

Changing Your Password
If you know the password for your CTRP user account, you can change it.
1. On the Registration login page (https://trials.nci.nih.gov/registration), click Reset Password. On the Reset Password tab, click the CTRP
Password Self Service Station link. The Change Your Password page appears. (For a more direct route to this page, visit https://trials.nci.nih.gov
/ctrp-password.)
2. Enter your CTRP username, old password, and new password. The new password must meet the following requirements:
Must be 8-15 characters.
Must have at least one uppercase letter (A-Z), one lowercase letter (a-z), one digit (0-9), and one special character. Special characters
include the following:
!"#$%&'()*+,-./:;<=>?@[\]^_`{|}~
Must not match any of the previous 6 passwords for this account.
3. Enter the new password again to confirm.
4. Click Submit. If the new password met all requirements, a confirmation page appears. Passwords remain in effect for 60 days.
If you have forgotten the password for your CTRP user account, refer to Resetting Your Password.
If you have questions or want to report any issues, contact us at [email protected].

134

Resetting Your Password
If you have forgotten the password for your CTRP user account, or if you want to reset it for any reason, you can reset it.
1. On the Registration login page (https://trials.nci.nih.gov/registration), click Reset Password. On the Reset Password tab, click the CTRP
Password Self Service Station link. The Change Your Password page appears. (For a more direct route to this page, visit https://trials.nci.nih.gov
/ctrp-password.)
2. Click Email a Password Reset Link. The Email a Password Reset Link page appears. (For a more direct route to this page, visit https://trials.nci.
nih.gov/ctrp-password/?action=sendtoken.)
3. Enter your CTRP username and the email address associated with that account.
4. Click Submit. If the email address matches the username, the system sends an email message to that address.
5. Click the link inside that message. A page appears prompting for the new password.
6. Enter your CTRP username and new password. The new password must meet the following requirements:
Must be 8-15 characters.
Must have at least one uppercase letter (A-Z), one lowercase letter (a-z), one digit (0-9), and one special character. Special characters
include the following:
!"#$%&'()*+,-./:;<=>?@[\]^_`{|}~
Must not match any of the previous 6 passwords for this account.
7. Enter the new password again to confirm.
8. Click Submit. If the new password met all requirements, a confirmation page appears. Passwords remain in effect for 60 days.
If you have questions or want to report any issues, contact us at [email protected].

135

Managing Your User Account Profile
You can update your account information after you have registered for an account and have logged in to Registration.
Changing your Organizational Affiliation results in loss of privileges
If you change your organizational affiliation, the system revokes your existing Site Admin and Accrual Submission privileges.
How to Edit Your Account Information
1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the top right corner of any page, click Your Username > My Account.
The My Account page appears, populated with the information you previously supplied for your account.
4. In the Your Account Profile section, make any changes as necessary, and then click Save.
Keep your account up to date
The PRS organization name is required for uploading trial records to ClinicalTrials.gov via a system-generated file. The PRS organization
name you include in your profile is included in that file. This precludes having to update the PRS name in the file. Therefore it is very
important for you to update your account whenever there is a change in PRS.

136

Viewing Trial-Related Documents
This section provides instructions for accessing and viewing trial documents.
Trial-related documents include, but are not limited to the following types:

Complete Protocol document
IRB Approval
List of Participating Sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact information.
Informed Consent
Only trial owners and administrators can view/download trial-related documents.
How to Download Trial-Related Documents
1. Click the NCI Trial Identifier link associated with the trial of interest.
The metadata for the selected trial is displayed in a new page.
2. In the section at the bottom of the page, click the link associated with the document of interest.
A dialog box appears in which you are given the option to open the document or save it to a location of your choice.
3. Follow your browser/operating system instructions to view or save the document.
If a trial has been updated or amended, there is likely to be more than one (1) Trial Summary Report (TSR) listed. You can view and download
each of them separately. To access Trial Summary Reports and XML documents, see Viewing Trial Summary Reports and XML Documents.

137

Working with Tables and Search Results
The system lists search results in tables. You can navigate through the records in several ways, and choose which columns are of interest to you.
Additionally, you can filter the results by typing a string of characters in a search field.
To do this...

Do this...

Move horizontally across the page

Press the Left arrow (<–) or Right arrow (–>) on your keyboard

Sort your results by column

Click the Sort icons

Move to the first page of results

Click <<

Move to the previous page of results

Click < or click the preceding page number

Move to the next page of results

Click > or click the next page number

Move to the last page of results

Click >>

Move to a specific page of results

Click a specific page number

Choose how many rows you want to
display per page

Select the number of rows from the Show selector

Choose which columns to display

Click Choose columns. A list of available columns appears. Check or clear the boxes to indicate which
columns you want to show or hide.

Search the list of results by keywords

In the Search field, type one or more characters contained in your keyword(s). The results are filtered as you
type subsequent characters.

Export search results to a file

At the bottom of the page, click CSV to export the search results to a comma-separated file or Excel to
export to a file in Microsoft Excel format.

For more instructions, refer to Filtering Registration Search Results.

138

Filtering Registration Search Results
To filter the search results, in the Search field, type one or more characters contained in any of the fields. The list is filtered as you type subsequent
characters.
For example, in the figure below, the results list has been filtered to display only trials that contain "004" in the NCI Identifier.

Adding one more character, as shown below, filtered out the remaining trial because the number "9" was not included in the NCI Identifier.

139

CTRP Registration Reference
The following pages provide tables and other reference material relevant to CTRP Registration:

140

CTRP Trial Categories, Study Sources
Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category (study source). For more information, refer to https://canc
ercenters.cancer.gov/GrantsFunding/eData#dt4.
Complete Trials:
National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by
the NIH or organizations on this list: Organizations with Peer Review Funding Systems.
Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer
review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center investigator has primary
responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results.
It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial should
clearly be the intellectual product of the center investigator.
This category may also include:
Institutional studies authored and implemented by investigators at another Center in which your Center is participating.
Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and externally
peer-reviewed studies should be listed with those categories, not as Institutional studies.)
Abbreviated Trials:
Industrial/Other: A pharmaceutical company controls the design and implementation of these clinical research studies.
Keep in mind the following points about the entities in CTRP that represent NCI-designated Cancer Centers:
A CTRP organization family represents an NCI-designated Cancer Center family of organizations. For brevity, this guide refers to this entity as a C
ancer Center family, a Cancer Center, or an organization family.
A CTRP organization that is a member of a Cancer Center family is considered a Cancer Center organization. For brevity, this guide refers to this
entity as a Cancer Center organization.

141

Data Table 4 Anatomic Site Values
CTRP uses the following values to identify the anatomic sites on which each trial or study is focused:
Anus
Bones and Joints
Brain and Nervous System
Breast - Female
Breast - Male
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Hodgkin's Lymphoma
Ill-Defined Sites
Kaposi's Sarcoma
Kidney
Larynx
Leukemia, not otherwise specified
Leukemia, other
Lip, Oral Cavity and Pharynx
Liver
Lung
Lymphoid Leukemia
Melanoma, Skin
Multiple
Multiple Myeloma
Mycosis Fungoides
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Hematopoietic
Other Male Genital
Other Respiratory/Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue / Sarcoma
Stomach
Thyroid
Unknown Sites
Urinary Bladder

142

Expanded Access Statuses
Trial status refers to the current stage or state of participant/patient enrollment in a clinical trial relative to other stages. CTRP uses the same statuses at
the trial level and at the participating site level. The following table lists the valid Expanded Access trial statuses used in CTRP and in ClinicalTrials.gov.
For information on other trial statuses used in CTRP and in ClinicalTrials.gov, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.

Current trial status definitions
#

Trial Status
Values

Status
Category

Definition

1

Available

Open

Expanded access is currently available.

2

No longer
available

Terminal

Expanded access was available previously but is not currently available and is not expected to be available in the future.

3

Temporarily not
available

Open

Expanded access was previously available, is not currently available, but is expected to be available in the future.

4

Approved for
marketing

Terminal

Expanded access was available previously, but is not currently available because the product has been approved, licensed, or
cleared by the U.S. Food and Drug Administration.

143

Funding Mechanism Code Values
CTRP allows you to specify the funding mechanism for a trial as a unique three-character code. NIH assigns one of these codes to each area of
extramural research activity. This code identifies the funding mechanism of a grant on a trial. The following table provides the name for each code:
Funding
Mechanism Code

Funding Mechanism Name

B01

Preventive Health Services

B08

Substance Abuse Prevention and Treatment Block Grant

B09

Mental Health Services Block Grant

C06

Research Facilities Construction Grant

D43

International Training Grants in Epidemiology

D71

International Training Program Planning Grant

DP1

NIH Director's Pioneer Award (NDPA)

DP2

NIH Director's New Innovator Awards

DP3

Type 1 Diabetes Targeted Research Award

E11

Grants for Public Health Special Projects

F05

International Research Fellowships (FIC)

F30

Individual Predoctoral NRSA for M.D./Ph.D. Fellowships (ADAMHA)

F31

Predoctoral Individual National Research Service Award

F32

Postdoctoral Individual National Research Service Award

F33

National Research Service Awards for Senior Fellows

F34

MARC (NRSA) Faculty Fellowships

F37

Medical Informatics Fellowships

F38

Applied Medical Informatics Fellowships

G07

Resources Improvement Grant

G08

Resources Project Grant (NLM)

G11

Extramural Associate Research Development Award (EARDA)

G12

Research Centers in Minority Institutions Award

G13

Health Sciences Publication Support Awards (NLM)

G20

Grants for Repair, Renovation and Modernization of Existing Research Facilities (NCRR)

G94

Administrative Support for Public Health Service Agency Foundations

H13

Conferences

H23

Immunization Program

H25

Venereal Disease Control

H28

State and Community-Based Injury Control Programs

H50

Maternal and Child Health Services Project, RB Funds

H57

Indian Health Service Loan Repayment Program

H62

Services or Education on AIDS

H64

State and Community-Based Childhood Lead Poisoning Prevention Program

H75

Health Investigations/Assessments of Control/Preven. Methods

H79

Mental Health and/or Substance Abuse Services Grants

HD4

Drug Use/Alcohol Abuse Prevention Demo: Community Partnership Study

144

HR1

State Mental Health and Substance Abuse Data Resource Projects

HS5

Child Mental Health Services Initiative: Comprehensive Community Mental Health Services for Children and Adolescents with
Serious Emotional Disturbances

I01

Non-DHHS Research Projects

K01

Research Scientist Development Award - Research & Training

K02

Research Scientist Development Award - Research

K05

Research Scientist Award

K06

Research Career Awards

K07

Academic/Teacher Award (ATA)

K08

Clinical Investigator Award (CIA)

K12

Physician Scientist Award (Program) (PSA)

K14

Minority School Faculty Development Awards

K18

The Career Enhancement Award

K21

Scientist Development Award

K22

Career Transition Award

K23

Mentored Patient-Oriented Research Career Development Award

K24

Midcareer Investigator Award in Patient-Oriented Research

K25

Mentored Quantitative Research Career Development Award

K26

Midcareer Investigator Award in Biomedical and Behavioral Research

K30

Clinical Research Curriculum Award (CRCA)

K99

Career Transition Award

KD1

Mental Health and/or Substance Abuse KD&A Grants

KL1

Linked Research Career Development Award

KL2

Mentored Career Development Award

KM1

Institutional Career Enhancement Awards - Multi-Yr Funding

L30

Loan Repayment Program for Clinical Researchers

L32

Loan Repayment Program for Clinical Researchers from Disadvantaged Backgrounds

L40

Loan Repayment Program for Pediatric Research

L50

Loan Repayment Program for Contraception and Infertility Research

L60

Loan Repayment Program for Health Disparities Research

M01

General Clinical Research Centers Program

N01

Research and Development Contracts

N02

Resource and Support Contracts - Awarded in the ICD

N03

Station Support Contracts - Awarded by the Division of Procurement

N43

Small Business Innovation Research - Phase I (Contract)

N44

Small Business Innovation Research - Phase II (Contract)

P01

Research Program Projects

P20

Exploratory Grants

P30

Center Core Grants

P40

Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants (NCRR)

P41

Biotechnology Resource Grants

145

P42

Hazardous Substances Basic Research Grants Program (NIEHS)

P50

Specialized Center

P51

Primate Research Center Grants (NCRR)

P60

Comprehensive Center

P76

Projects to Design and implement Health Exhibits/Materials for Public Education

PL1

Linked Center Core Grant

PN1

Concept Development Award

PN2

Research Development Center

R00

Research Transition Award

R01

Research Project

R03

Small Research Grants

R04

Anthrop. Fellow Res. Support (old

R06

Translations

R08

Development of Innovative Technology for Measurement of Lead

R13

Conference

R15

Academic Research Enhancement Awards (AREA)

R17

Mental Health Career Investigator Grants Active

R18

Research Demonstration and Dissemination Projects

R21

Exploratory/Developmental Grants

R24

Resource-Related Research Projects

R25

Education Projects

R30

Preventive Health Service - Venereal Disease Research, Demonstration, and Public Information and Education Grants

R33

Exploratory/Developmental Grants Phase II

R34

Clinical Trial Planning Grant

R36

Dissertation Award

R37

Method to Extend Research in Time (MERIT) Award

R41

Small Business Technology Transfer (STTR) Grants - Phase I

R42

Small Business Technology Transfer (STTR) Grants - Phase II

R43

Small Business Innovation Research Grants (SBIR) - Phase I

R44

Small Business Innovation Research Grants (SBIR) - Phase II

R49

Injury Control Research and Demonstration Projects and Injury Prevention Research Centers

R55

James A. Shannon Director's Award

R56

High Priority, Short Term Project Award

R90

Interdisciplinary Regular Research Training Award

RC1

NIH Challenge Grants and Partnerships Program

RC2

High Impact Research and Research Infrastructure Programs

RC3

Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RC4

High Impact Research and Research Infrastructure Programs Multi Year Funding

RL1

Linked Research project Grant

RL2

Linked Exploratory/Development Grant

RL5

Linked Education Project

146

RL9

Linked Research Training Award

RS1

Programs to Prevent the Emergence and Spread of Antimicrobial Resistance in the United States

S06

Minority Biomedical Research Support - MBRS

S10

Biomedical Research Support Shared Instrumentation Grants (NCRR)

S11

Minority Biomedical Research Support Thematic Project Grants

S21

Research and Institutional Resources Health Disparities Endowment Grants -Capacity Building

S22

Research and Student Resources Health Disparities Endowment Grants - Educational Programs

SC1

Research Enhancement Award

SC2

Pilot Research Project

SC3

Research Continuance Award

T01

Graduate Training Program

T02

Undergraduate Training Program

T03

Combined Undergraduate and Graduate Training Program

T06

Minority Supplements to Clinical Training Grants

T09

Scientific Evaluation

T14

Conferences

T15

Continuing Education Training Grants

T32

Institutional National Research Service Award

T34

MARC Undergraduate NRSA Institutional Grants

T35

NRSA Short -Term Research Training

T36

MARC Ancillary Training Activities (Grant) (NIGMS)

T37

Minority International Research Training Grants (FIC)

T42

Educational Resource Center Training Grants

T90

Interdisciplinary Research Training Award

TL1

Linked Training Award

TU2

Institutional National Research Service Award with Involvement of NIH Intramural Faculty

U01

Research Project--Cooperative Agreements

U09

Scientific Review and Evaluation--Cooperative Agreements

U10

Cooperative Clinical Research--Cooperative Agreements

U11

Study (in China) of Periconceptional Vitamin Supplements to Prevent Spina Bifida and Anencephaly Cooperative Agreements

U13

Conference--Cooperative Agreements

U14

Public Health Leadership Institute Cooperative Agreement

U17

Applied Methods in Violence-Related or Accidental Injury Surveillance Cooperative Agreements

U18

Research Demonstration--Cooperative Agreements

U19

Research Program--Cooperative Agreements

U1A

Capacity Building for Core Components of Tobacco Prevention and Control Programs Cooperative Agreements

U1Q

Emergency Disaster Relief Relating to CDC Programs Cooperative Agreement

U1S

Emergency Disaster Relief Relating to SAMHSA Programs Cooperative Agreements

U1T

Violence Prevention Training for Minority Medical Students Cooperative Agreement

U1V

Capacity Building for Core Components of Tobacco Prevention and Control Programs Cooperative Agreements

U21

Immunization Service for Racial and Ethnic Minorities, Cooperative Agreements

147

U22

HIV/STD Preventive Services for Racial and Minorities

U23

TB Prevention and Control Services for Racial and Ethnic Minorities Cooperative Agreements

U24

Resource-Related Research Related Cooperative Agreements

U27

Surveillance of Complications of Hemophilia Cooperative Agreements

U2G

Global HIV/AIDS Non-Research Cooperative Agreements

U2R

International Training Cooperative Agreement

U30

Prev. Health Services: Venereal Disease Research, Demonstration, and Public Information and Education Projects

U32

State-based Diabetes Control Programs

U34

Clinical Planning Grant Cooperative Agreement

U36

Program Improvements for Schools of Public Health

U38

Uniform National Health Program Reporting System

U41

Biotechnology Resource Cooperative Agreements

U42

Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements
(NCRR)

U43

Small Business Innovation Research (SBIR) Cooperative Agreements - Phase I

U44

Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II

U45

Hazardous Waste Worker Health and Safety Training Cooperative Agreements (NIEHS)

U47

Laboratory/Other Diagnostic Medical Quality Improvement Cooperative Agreements

U48

Health Promotion and Disease Prevention Research Centers

U49

Coop: Injury Control Res. and Demo and Injury Prevention

U50

Special Cooperative Investigations/Assessment of Control/Prevention Methods

U51

Health Planning Strategies/National Academy of Sciences Activities

U52

Cooperative Agreement for Tuberculosis Control

U53

Capacity Bldg: Occupational Safety/Community Environmental Health

U54

Specialized Center--Cooperative Agreements

U55

Core Support For American Council on Transplantation Active

U56

Exploratory Grants--Cooperative Agreements

U57

State-Based Comprehensive Breast/Cervical Cancer Control Program Cooperative Agreements

U58

Chronic Disease Control Cooperative Agreement

U59

Disabilities Prevention Cooperative Agreement Program

U60

Cooperative Agreements in Occupational Safety and Health Research, Demonstrations, Evaluation and Education Research,
Demonstrations, Evaluation and Education

U61

Preventive Health Activities Regarding Hazardous Substances

U62

Prevention/Surveillance Activities/Studies of AIDS

U65

Minority/Other Community-based HIV Prevention Project, Cooperative Agreements

U66

Immunization Demonstration Projects Cooperative Agreements

U75

National Cancer Registries Cooperative Agreements

U79

Mental Health and/or Substance Abuse Services Cooperative Agreements

U81

Injury Community Demonstration Projects: Evaluation of Youth Violence Prevention Program

U82

Enhancement of State and Local Capacity to Assess the Progress toward Healthy People 2010 Objectives

U83

Research to Advance the Understanding of the Health of Racial and Ethnic Populations or Subpopulations Cooperative
Agreements

U84

Cooperative Agreements for Fetal Alcohol Syndrome Prevention Research Programs

148

U87

State Demonstration: Comprehensive School Health Program to Prevent Sexual Behaviors that Result in HIV Infection and to
Improve Educati onal Outcome Cooperative Agreements

U88

Services Demonstration Cooperative Agreements

U90

Cooperative Agreements for Special Projects of National Significance (SPNS)

UA1

AIDS Research Project Cooperative Agreement

UC1

NIH Challenge Grants and Partnerships Program - Phase II-Coop.Agreement

UC2

High Impact Research and Research Infrastructure Cooperative Agreement Programs

UC3

Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Cooperative
Agreement Program

UC6

Construction Cooperative Agreement

UC7

National Biocontainment Laboratory Operation Cooperative Agreement

UD1

Mental Health and/or Substance Abuse KD&A Cooperative Agreements

UE1

Studies of Environmental Hazards and Health Effects

UE2

Emergency and Environmental Health Services

UH1

HBCU Research Scientist Award

UH2

Exploratory/Developmental Cooperative Agreement Phase I

UH3

Exploratory/Developmental Cooperative Agreement Phase II

UL1

Linked Specialized Center Cooperative Agreement

UR1

Cooperative Agreements for Resources and Technical Assistance Projects to Support Mental Health and Substance Abuse
Services

UR3

School Health: Findings from Evaluated Programs Cooperative Agreements

UR6

Prevention Intervention Research on Substance Abuse in Children Cooperative Agreements

UR8

Applied Research in Emerging Infections-(including Tick-borne Diseases) Cooperative Agreements

US3

Hantaviral Reservoir Studies Cooperative Agreements

US4

Community-Based Primary Prevention Programs: Intimate Partner Violence Cooperative Agreements

UT1

Small Business Technology Transfer (STTR) – Cooperative Agreements - Phase I

UT2

Small Business Technology Transfer (STTR) – Cooperative Agreements - Phase II

VF1

Rape Prevention and Education Grants

X01

Resource Access Award

X02

Preapplication

X06

Projects for Assistance in Transition from Homelessness

X98

Protection and Advocacy for Mentally Ill Individuals

Y01

NIH Inter-Agency Agreements

Y02

NIH Intra-Agency Agreements

Z01

Intramural Research

Z02

Intramural Research Resources

Z1A

Investigator-Initiated Intramural Research Projects

149

NCI Division and Program Values
The following table provides the NCI values used to identify the name of the NCI division or program responsible for a grant.
Division/Program Value

Definition

CCR

Center for Cancer Research

CCT/CTB

Center for Cancer Training/Cancer Training Branch

CDP

Cancer Diagnosis Program

CIP

Cancer Imaging Program

CTEP

Cancer Therapy Evaluation Program

DCB

Division of Cancer Biology

DCCPS

Division of Cancer Control and Population Sciences

DCEG

Division of Cancer Epidemiology and Genetics

DCP

Division of Cancer Prevention

DEA

Division of Extramural Activities

DESP

Division of Extramural Science Programs

DTP

Developmental Therapeutics Program

OD

Office of the Director, NCI, NIH

OSB/SPORE

Organ Systems Branch/Specialized Programs of Research Excellence

RRP

Radiation Research Program

TRP

Translational Research

N/A

Not applicable

150

NIH Grant Institute Code Values
The following table lists each two-letter code identifying the organization that supports an NIH grant, contract, or inter-agency agreement. The support may
be financial or administrative. You can associate the NIH institute with a trial, in a grant record.
Code

Organization

AA

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

AE

Office of the Assistant Secretary for Planning and Evaluation

AF

Administration for Children and Families

AG

National Institute on Aging (NIA)

AI

National Institute of Allergy and Infectious Diseases Extramural Activities (NIAID)

AM

National Institute of Arthritis, Diabetes, Digestive, and Kidney Diseases

AO

NIAID Research Support

AR

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

AT

National Center for Complementary and Integrative Health (NCCIH)

BC

Division of Basic Sciences (NCI)

BX

Biomedical Laboratory Research and Development

CA

National Cancer Institute (NCI)

CB

Division of Cancer Biology and Diagnosis (NCI)

CD

Office of the Director, Centers for Disease Control and Prevention

CE

National Center for Injury Prevention and Control

CH

Coordinating Center for Infectious Diseases

CI

National Center for Infectious Diseases (NCID)

CK

National Center for Zoonotic, Vector-borne, and Enteric Diseases

CL

Clinical Center (CLC)

CM

Division of Cancer Treatment (NCI)

CN

Division of Cancer Prevention and Control (NCI)

CO

Office of the Director (NCI)

CP

Division of Cancer Epidemiology and Genetics (NCI)

CR

Cooperative Research and Development Agreements (NCI)

CT

Center for Information Technology (CIT)

CU

Cooperative Studies Program

CX

Clinical Science Research and Development

DA

National Institute on Drug Abuse (NIDA)

DC

National Institute on Deafness and Other Communication Disorders (NIDCD)

DD

Centers for Disease Control and Prevention

DE

National Institute of Dental and Craniofacial Research (NIDCR)

DK

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

DP

National Center for Chronic Disease Prevention and Health Promotion

EB

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

EH

National Center for Environmental Health

EM

Environmental Health Services

151

EP

Epidemiology Program Office

ES

National Institute of Environmental Health Sciences (NIEHS)

EY

National Eye Institute (NEI)

FD

Food and Drug Administration

GD

Office of Genomics and Disease Prevention

GH

Coordinating Office of Global Health

GM

National Institute of General Medical Sciences (NIGMS)

GW

Genome Association Studies (GAS)

HB

Division of Blood Diseases and Resources (NHLBI)

HC

Division of Epidemiology and Clinical Applications (NHLBI)

HD

National Institute of Child Health and Human Development (NICHD)

HG

National Human Genome Research Institute (NHGRI)

HI

Division of Intramural Research (NHLBI)

HK

Office of National Center for Public Health Informatics

HL

National Heart, Lung, and Blood Institute (NHLBI)

HM

National Center for Health Marketing

HO

Office of the Director (NHLBI)

HP

Health Resources and Services Administration / Bureau of Health Professions

HR

Division of Lung Diseases (NHLBI)

HS

Agency for Healthcare Research and Quality

HV

Division of Heart and Vascular Diseases (NHLBI)

HX

Health Services Research and Development

HY

Office of Health and Safety

IP

National Center for Immunization and Respiratory Diseases

JT

Joint Funding

LM

National Library of Medicine (NLM)

MD

National Institute on Minority Health and Health Disparities (NIMHD)

MH

National Institute of Mental Health (NIMH)

MN

Office of Minority Health

NB

Neuroscience Blueprint (NB)

NH

National Institutes of Health

NR

National Institute of Nursing Research (NINR)

NS

National Institute of Neurological Disorders and Stroke (NINDS)

NU

Division of Nursing

OA

Office of the Administrator (SAMHSA)

OC

Office of the National Coordinator for Health Information Technology, OS, HHS

OD

Office of the Director (NIH)

OF

Office of Research Facilities Development and Operations (ORFDO)

OH

National Institute for Occupational Safety and Health

OL

Office of Logistics and Acquisition Operations (OLAO)

OR

Office of Research Services (ORS)

152

PC

Division of Cancer Control and Population Science (NCI)

PH

Public Health Practice Program Office

PR

Office of Chief Public Health Practice

PS

National Center for HIV, Viral Hepatitis, STD, and TB Prevention

RC

Center for Cancer Research (CCR)

RD

Office of Research and Development

RG

Center for Scientific Review (CSR)

RM

NIH Roadmap Initiative, Office of the Director (RMOD)

RR

National Center for Research Resources (NCRR)

RX

Rehabilitation Research and Development

SC

Division of Clinical Sciences (NCI)

SF

Superfund Basic Research Program (SBRP)

SH

National Center for Health Statistics

SM

Center for Mental Health Services

SP

Center for Substance Abuse Prevention

SU

Substance Abuse and Mental Health Services Administration

TI

Center for Substance Abuse Treatment

TP

Coordinating Office for Terrorism Preparedness and Emergency Response

TR

National Center for Advancing Translational Sciences (NCATS)

TS

Agency for Toxic Substances and Disease Registry

TW

John E. Fogarty International Center (FIC)

VA

Veterans Affairs

WC

Office of Workforce and Career Development

WH

Women's Health Initiative (WHI, OD)

WT

Worker Education Training Program (WETP)

153

NIH Institution Code Values
The following table lists NIH institution codes. You can associate the NIH institution with a trial, in an IND or IDE record.
Valid Value

Definition

NEI

National Eye Institute

NHLBI

National Heart, Lung, and Blood Institute

NHGRI

National Human Genome Research Institute

NIA

National Institute on Aging

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIAID

National Institute of Allergy and Infectious Diseases

NIAMS

National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIBIB

National Institute of Biomedical Imaging and Bioengineering

NICHD

Eunice Kennedy Shriver National Institute of Child Health and Human Development

NIDCD

National Institute on Deafness and Other Communication Disorders

NIDCR

National Institute of Dental and Craniofacial Research

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases

NIDA

National Institute on Drug Abuse

NIEHS

National Institute of Environmental Health Sciences

NIGMS

National Institute of General Medical Sciences

NIMH

National Institute of Mental Health

NINDS

National Institute of Neurological Disorders and Stroke

NINR

National Institute of Nursing Research

NLM

National Library of Medicine

CIT

Center for Information Technology

CSR

Center for Scientific Review

FIC

John E. Fogarty International Center for Advanced Study in the Health Sciences

NCCAM

National Center for Complementary and Alternative Medicine

NCMHD

National Center on Minority Health and Health Disparities

NCRR

National Center for Research Resources (NCRR

CC

NIH Clinical Center

OD

Office of the Director

154

Primary Purpose Value Definitions
CTRP allows you to choose one of the following values when specifying the main reason for conducting the trial.
CTRP
Primary
Purpose
Value

Definition

Treatment

Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or condition.

Prevention

Protocol is designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.

Supportive
Care

Protocol is designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or
mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a
disease.

Screening

Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet
known to have the condition (or risk factor).

Diagnostic

Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health condition.

Health
Services
Research

Protocol is designed to evaluate the delivery, processes, management, organization, or financing of health care.

Basic
Science

Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention.

Device
Feasibility

Protocol is designed to evaluate an intervention of a device product, to determine the feasibility of the product or to test a prototype
device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before
beginning a full clinical trial.

Other

Any purpose not described above.

155

Status Rules for Trial Dates
Valid dates for a given trial status depend on the other values you have entered, and whether those dates are Actual or Anticipated. The following table
illustrates these rules:
Status

Start Date Type

Primary Completion Date Type

Completion Date Type

Can be Actual or Anticipated.

Can be Actual or Anticipated.

Must be Anticipated.

Must be Actual.

Can be Actual or Anticipated.

Can be Actual or Anticipated.

Must be Actual.

Must be Actual.

Can be Actual or Anticipated.

In Review
Approved
Withdrawn
Active
Enrolling by Invitation

Temporarily Closed to Accrual
Temporarily Closed to Accrual and Intervention
Closed to Accrual
Closed to Accrual and Intervention

Complete
Administratively Complete

The general rules for Study Date types are as follows:
If the date is in the past, the type must be Actual.
If the date is today, the type could be Actual or Anticipated.
If the date is in the future, the type must always be Anticipated.
The general rules for Study Date values are as follows:
The Trial Start Date can be in the past, present, or future.
The Primary Completion Date is always the same as, or later than, the Trial Start Date.
If the Primary Completion Date is Actual, it can be earlier than the Current Trial Status Dates Complete or Administratively Complete.
The Completion Date is always the same as, or later than, the Primary Completion Date.

156

Status Transition Rules
The table and diagram below provide rules for ensuring that you record valid transitions between trial statuses and participating site statuses.

Trial Status Flow Relationships
A trial can proceed from
this status…

Directly to this status

In Review

Or to this status

Active/Enrolling by Invitation
Approved
Withdrawn
This can occur when the trial has been Approved and is Active
/Enrolling by Invitation on the same day

Approved

NA
Active/Enrolling by Invitation
Withdrawn

Active/Enrolling by Invitation

Closed to Accrual
Temporarily Closed to Accrual
Temporarily Closed to Accrual and Intervention
Closed to Accrual and Intervention
Administratively Completed
Completed

Closed to Accrual
Closed to Accrual and
Intervention

Temporarily Closed to Accrual

Temporarily Closed to Accrual
and Intervention

Closed to Accrual and
Intervention

Administratively Completed
NA

Completed
Administratively Completed
Temporarily Closed to Accrual
and Intervention

Active/Enrolling by Invitation
Closed to Accrual
Closed to Accrual and Intervention
Administratively Completed

Administratively Completed
Active/Enrolling by Invitation
Closed to Accrual
Closed to Accrual and Intervention

The diagram below illustrates the flow and transitions among trial statuses. The system records the statuses in the order indicated by the arrows. Doubleended arrows indicate that a transition between statuses can be recorded in either order. For example, a status can transition from Active/Enrolling by
Invitation to Temporarily Closed to Accrual and Intervention, or conversely, from Temporarily Closed to Accrual and Intervention to Active/Enrolling by
Invitation.

157

Trial Status Transitions

158

Trial Phase Value Definitions
When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving
investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP values:
CTRP
Phase
Value

ClinicalTrials.
gov Phase Value

Definition

Early
Phase I

Early Phase 1
(Formerly listed as
"Phase 0")

Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening
studies, microdose studies). See FDA guidance on exploratory IND studies for more information.

I

Phase 1

Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects
associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and
/or patients.

I/II

Phase 1/Phase 2

Trials that are a combination of phases 1 and 2.

II

Phase 2

Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or
indications in participants with the disease or condition under study and to determine the common short-term side
effects and risks.

II/III

Phase 2/Phase 3

Trials that are a combination of phases 2 and 3.

III

Phase 3

Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are
intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.

IV

Phase 4

Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal
use.

NA

N/A

Trials without phases (for example, studies of devices or behavioral interventions).

159

Trial Processing Statuses
The following table provides the definitions of each of the statuses that occur during the course of the trial processing work flow. The diagram (after the
table) illustrates the work flow so that you can see the relationships between the trial statuses.
Trial Processing
Status

Definition

All

Any processing status.

Submitted

Original trial submitted but not validated.

Amendment
Submitted

Amendment submitted but not validated.

Accepted

Trial passed validation.

Rejected

Trial did not pass validation.
These trials are displayed in PA but not in trial search results in the Registration application.

Abstracted

Trial has been abstracted.

Verification
Pending

Trial has been abstracted, and the Trial Summary Report (TSR) has been sent to the trial submitter for abstraction verification.

Abstraction
Verified Response

Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days after
receiving the TSR.
(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel
Management's list of Federal Holidays.)

Abstraction
Verified No
Response

Submitter has not responded or returned verification feedback to the CTRO within five business days after receiving the TSR.

On-Hold

Trial has been delayed, or there is not enough information to process the submission.

Submission
Terminated

Trial processing has been terminated in PA. (For example, a Registration application user may have requested termination.)
These trials are displayed in PA but not in trial search results in the Registration application.

Submission
Reactivated

Trial processing has resumed in PA.

160

161

Trial Status Values in the CTRP and ClinicalTrials.gov
Trial status refers to the current stage or state of participant/patient enrollment in a clinical trial relative to other stages. CTRP uses the same statuses at
the trial level and at the participating site level. The following table lists the valid trial statuses used in CTRP and maps each value to the corresponding
ClinicalTrials.gov-defined recruitment value.
For information on Expanded Access trial statuses, refer to Expanded Access Statuses.

Current trial status definitions
#

CTRP Trial Status
Values

ClinicalTrials.gov
Trial Status Values

Status
Category

Definition

01

In Review

Not yet recruiting

Review

Participants are not yet being recruited.

11

Withdrawn

Withdrawn

Terminal

Study halted prematurely, prior to enrollment of first participant.

02

Approved

Not yet recruiting

Review

Participants are not yet being recruited.

03

Active

Recruiting

Open

Participants are currently being recruited, whether or not any participants have yet been
enrolled.

04

Enrolling by Invitation

Enrolling by Invitation

Open

Participants are being (or will be) selected from a predetermined population.

08

Temporarily Closed to
Accrual

Suspended

Open

Study halted prematurely but potentially will resume.

09

Temporarily Closed to
Accrual and Intervention

Suspended

Open

Study halted prematurely but potentially will resume.

05

Closed to Accrual

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined,
but new participants are not currently being recruited or enrolled.

06

Closed to Accrual and
Intervention

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined,
but new participants are not currently being recruited or enrolled.

10

Administratively Complete

Terminated

Terminal

Study halted prematurely and will not resume; participants are no longer being examined
or receiving intervention.

07

Complete

Completed

Terminal

The study has concluded normally; participants are no longer receiving an intervention or
being examined (that is, last participant’s last visit has occurred).

162

Trial Summary Report and XML File Data Elements
The CTRP system captures the trial data you submit, and from them generates two types of trial documents: a Trial Summary Report (TSR), formatted for
user consumption; and an XML file formatted for upload to ClinicalTrials.gov. Both documents contain a subset of trial data elements captured in the
CTRP. However, the TSR contains more elements than the XML because ClinicalTrials.gov-required fields are different from those in CTRP. Some data
that appear in the TSR do not appear in the XML, and vice versa. The documents are described below.
Trial Summary Report (TSR) – Report that presents a summary of key abstracted data from the trial you registered, in an easy-to-read format.
The CTRP system sends the TSR as an attachment in an email to the trial submitter/owner with instructions to review the TSR for accuracy and
to report any changes to the CTRO staff.
When a trial has been amended, the system sends a modified TSR to the submitter that reflects the changes.

XML File – File that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. You may want to make sure the trial
record in CTRP has all of the trial attributes required for ClinicalTrials.gov before you use CTRP to generate an XML file from that trial record, to
avoid having to make corrections/additions in ClinicalTrials.gov.
The following sections compare the TSR data elements with those in the XML.
For instructions on viewing these trial documents, refer to Viewing Trial Summary Reports and XML Documents.

163

TSR-XML Data Element Comparisons
Use the horizontal scroll bar to display hidden columns
If you don't see all four columns in the table below, scroll down to the bottom of the table and use the horizontal scroll bar to display them.

Data Fields

Sample TSR Data

Sample Corresponding XML Data

Comments

Record Verification Date

2013-03

<verification_date>2013-03<
/verification_date>

NA

Trial Category

Complete

(Not included in the XML file)

ClinicalTrials.gov does not
capture this field

Trial Type

Interventional

<study_type>Interventional</study_type>

NA

NCI Trial Identifier

NCI-2011-9999

<id_info>
<secondary_id>
<id>NCI-2011-99999</id>
<id_type>Registry Identifier</id_type>
<id_domain>CTRP (Clinical Trial Reporting
Program)</id_domain>
</secondary_id>
</id_info>

NA

ClinicalTrials.gov Identifier

NCT01234567

(Not included in the XML file)

NA

Lead Organization (Trial)
Identifier

CCCCWFU 12345

<org_study_id>CCCCWFU 12345</org_study_id>

Wake Forest University Health
Sciences is the Lead
Organization in this example

and
<id_info>
<secondary_id>
<id>CCCCWFU 12345</id>
<id_type>Other Identifier</id_type>
<id_domain>Wake Forest University Health
Sciences</id_domain>
</secondary_id>
</id_info>
DCP Identifier

WFU-01-01-06

<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>Registry Identifier</id_type>
<id_domain>DCP</id_domain>
</secondary_id>
</id_info>

ClinicalTrials.gov captures all
other identifiers as
<secondary_id>

CTEP Identifier

WFU-01-01-06

<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>Registry Identifier</id_type>
<id_domain>CTEP</id_domain>
</secondary_id>
</id_info>

ClinicalTrials.gov captures all
other identifiers as
<secondary_id>

CCR Identifier

CCR-123

(Not included in the XML file)

ClinicalTrials.gov captures all
other identifiers as
<secondary_id>

Amendment Date

02/10/2003

(Not included in the XML file)

ClinicalTrials.gov does not
capture this field

Amendment Number

35

(Not included in the XML file)

ClinicalTrials.gov does not
capture this field

Type

Interventional

<study_type>Interventional</study_type>

NA

Official Title

A Phase II Double-Blind Feasibility
Study of Armodafinil...

<official_title>
A Phase II Double-Blind Feasibility Study
of Armodafinil...
</official_title>

NA

Brief Title

Armodafinil in Treating Fatigue Caused
By Radiation Therapy in Patients With
Primary Brain Tumors

<brief_title>
Armodafinil in Treating Fatigue Caused By
Radiation Therapy in Patients With Primary
Brain Tumors
</brief_title>

NA

Acronym

ABC

<acronym>

NA

Brief Summary

This clinical trial is studying how well
Armodafinil works...

<brief_summary>
<textblock>
This clinical trial is studying how well

NA

164

Armodafinil works...
<textblock>
<brief_summary>
Detailed Description

Detailed Description...

<detailed_description>
<textblock>
Detailed Description...
</textblock>
</detailed_description>

NA

Primary Objectives

I. To estimate...

<detailed_description>
<textblock>
PRIMARY OBJECTIVES: I. To estimate...
</textblock>
</detailed_description>

NA

Secondary Objectives

I. To obtain a preliminary estimate...

<detailed_description>
<textblock>
SECONDARY OBJECTIVES: To obtain a
preliminary estimate...
</textblock>
</detailed_description>

NA

Outline

OUTLINE: This is a multicenter study...

<detailed_description>
<textblock>
OUTLINE: This is a multicenter study...
</textblock>
</detailed_description>

NA

Keywords

Feasibility Armodafinil; narcolepsy

<keyword>Feasibility Armodafinil</keyword>
<keyword>narcolepsy</keyword>

NA

Reporting Dataset Method

Complete

(Not included in the XML file)

Not required for the
ClinicalTrials.gov schema

Sponsor

National Cancer Institute

<sponsors>
<lead_sponsor>
<agency>National Cancer Institute</agency>
</lead_sponsor>
</sponsors>

NA

Lead Organization

Wake Forest University Health
Sciences

<overall_official>
<first_name>Jane</first_name>
<last_name>Doe</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health
Sciences</affiliation>
</overall_official>

NA

Principal Investigator

Jane Doe

<overall_official>
<first_name>Jane</first_name>
<last_name>Doe</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health
Sciences</affiliation>
</overall_official>

NA

Responsible Party

Sponsor

<resp_party_type>Sponsor</resp_party_type>

NA

Overall Official

Jane Doe (Principal Investigator) Wake
Forest University Health Sciences

<overall_official>
<first_name>Jane</first_name>
<last_name>Doe</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health
Sciences</affiliation>
</overall_official>

NA

Current Trial Status

Closed to Accrual and Intervention as
of 08/01/2012

<overall_status>Active, not recruiting<
/overall_status>

NA

Trial Start Date

08/01/2010-Actual

<start_date>2010-08</start_date>
<start_date_type>Actual</start_date_type>

NA

Primary Completion Date

01/11/2014-Actual

<primary_compl_date>2014-01<
/primary_compl_date>
<primary_compl_date_type>Actual<
/primary_compl_date_type>

NA

Completion Date

02/04/2014-Actual

<last_follow_up_date>2014-02<
/last_follow_up_date>

Not required for the
ClinicalTrials.gov schema

If no data are available, the
"<last_follow_up_date>" does not appear in
the XML file.

Regulatory Information >

Yes

<oversight_info>

165

NA

Studies a U.S. FDA-regulated
Drug Product

<fda_regulated_drug>Yes<
/fda_regulated_drug>
</oversight_info>

Regulatory Information >
Studies a U.S. FDA-regulated
Device Product

Yes

<oversight_info>
<fda_regulated_device>Yes<
/fda_regulated_device>
</oversight_info>

NA

Regulatory Information >
Unapproved/Uncleared Device?

Yes

<delayed_posting>Yes</delayed_posting>

NA

Regulatory Information > Post
Prior to U.S. FDA Approval or
Clearance

Yes

<oversight_info>
<post_prior_to_approval>Yes<
/post_prior_to_approval>
</oversight_info>

NA

Regulatory Information >
Pediatric Post-market
Surveillance (of a Device
Product)

Yes

<oversight_info>
<ped_postmarket_surv>Yes<
/ped_postmarket_surv>
</oversight_info>

NA

Regulatory Information >
Product Exported from the U.S.

Yes

<oversight_info>
<exported_from_us>Yes</exported_from_us>
</oversight_info>

NA

Regulatory Information > FDA
Regulated Intervention?

Yes

<is_fda_regulated>Yes</is_fda_regulated>

NA

Regulatory Information >
Section 801?

Yes

<is_section_801>Yes</is_section_801>

NA

Regulatory Information > DMC
Appointed?

Yes

<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>

NA

Regulatory Information > IND
/IDE Study?

Yes

<is_ind_study>Yes</is_ind_study>

NA

Board Approval Status

Submitted, approved

<irb_info>
<approval_status>Approved</approval_status>
</irb_info>

NA

Board Approval Number

IRB00012856

<irb_info>
<approval_number>IRB00012856<
/approval_number>
</irb_info>

NA

Board

Wake Forest University Health
Sciences

<irb_info>
<name>Wake Forest University Health
Sciences</name>
</irb_info>

NA

Affiliation

Wake Forest University Health
Sciences

<irb_info>
<affiliation>Wake Forest University Health
Sciences</affiliation>
</irb_info>

NA

IND/IDE > Type

IND

<ind_info>

Applies to IND and IDE

IND/IDE > Grantor

CBER

<ind_grantor>CBER</ind_grantor>

NA

IND/IDE > Number

119999

<ind_number>119999</ind_number>

NA

IND/IDE > Holder Type

NCI

(Not included in the XML file)

NA

IND/IDE > Availability of
Expanded Access

Yes

<has_expanded_access>Yes<
/has_expanded_access>

NA

IND/IDE > Expanded Access
Record

NCT12345678

<expanded_access_nct_id>NCT12345678<
/expanded_access_nct_id>

NA

NIH Grants > Funding
Mechanism

U10

<secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NA

NIH Grants > NIH Institution
Code

CA

<secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NA

NIH Grants > Serial Number

88888

<secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NA

NIH Grants > NCI Division
/Program Code

DCP

(Not included in the XML file)

NA

166

Data Table 4 Information >
Funding Category

Externally Peer-Reviewed

(Not included in the XML file)

Not required for the
ClinicalTrials.gov schema

Data Table 4 Information >
Funding Sponsor/Source

National Cancer Institute

(Not included in the XML file)

Not required for the
ClinicalTrials.gov schema

Data Table 4 Information >
Program Codes

2, 5, 12

(Not included in the XML file)

NA

Anatomic Site Code

Prostate

(Not included in the XML file)

Not required for the
ClinicalTrials.gov schema

Collaborator Name

National Cancer Institute

<collaborator>
<agency>National Cancer Institute</agency>
</collaborator>

Not required for the
ClinicalTrials.gov schema

Collaborator Role

Funding Source

(Not included in the XML file)

ClinicalTrials.gov does not
capture this field

Disease/Condition Name

Prostate Carcinoma

<condition>Prostate Carcinoma</condition>

NA

Trial Design > Type

Interventional

<study_type>Interventional</study_type>
and
<study_design>Interventional</study_design>

NA

Trial Design > Expanded
Access

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Trial Design > Primary Purpose

Prevention

<study_design>
<interventional_design>
<interventional_subtype>Prevention<
/interventional_subtype>
</interventional_design>
</study_design>

NA

Trial Design > Phase

II

<study_design>
<interventional_design>
<phase>II</phase>
</interventional_design>
</study_design>

NA

Trial Design > Interventional
Study Model

Parallel

<study_design>
<interventional_design>
<assignment>Parallel Assignment<
/assignment>
</interventional_design>
</study_design>

NA

Trial Design > Model
Description

Lorem ipsum dolor sit amet ...

<study_design>
<interventional_design>
<model_description>
<textblock>Lorem ipsum dolor sit amet ... <
/textblock>
</model_description>
</interventional_design>
</study_design>

NA

Trial Design > Number of Arms

2

<study_design>
<interventional_design>
<number_of_arms>2</number_of_arms>
</interventional_design>
</study_design>

NA

Trial Design > Masking

Participant, Investigator, Care Provider,
Outcomes Assessor

<study_design>
<interventional_design>
<no_masking>No</no_masking>
<masked_assessor>Yes</masked_assessor>
<masked_caregiver>Yes</masked_caregiver>
<masked_investigator>Yes<
/masked_investigator>
<masked_subject>Yes</masked_subject>
</interventional_design>
</study_design>

NA

Trial Design > Masking
Description

Lorem ipsum dolor sit amet ...

<study_design>
<interventional_design>
<masking_description>
<textblock>Lorem ipsum dolor sit amet ... <
/textblock>
</masking_description>
</interventional_design>
</study_design>

NA

Trial Design > Allocation

Randomized Controlled Trial

<study_design>
<interventional_design>
<allocation>Randomized Controlled Trial<

NA

167

/allocation>
</interventional_design>
</study_design>
Trial Design > Target
Enrollment

100

<enrollment>100</enrollment>

NA

Eligibility Criteria > Accepts
Healthy Volunteers?

No

<eligibility>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>

NA

Eligibility Criteria > Sex

Female

<eligibility>
<gender>Female</gender>
</eligibility>

NA

Eligibility Criteria > Gender
Based

Yes

<eligibility>
<gender_based>Yes</gender_based>
</eligibility>

NA

Eligibility Criteria > Gender
Eligibility Description

Lorem ipsum dolor sit amet ...

<eligibility>
<gender_description>
<textblock>Lorem ipsum dolor sit amet ... <
/textblock>
</gender_description>
</eligibility>

NA

Eligibility Criteria > Minimum
Age

18 Years

<eligibility>
<minimum_age>18 years</minimum_age>
</eligibility>

NA

Eligibility Criteria > Maximum
Age

N/A

<eligibility>
<maximum_age>N/A</maximum_age>
</eligibility>

NA

Eligibility Criteria > Inclusion
Criteria

Family history of prostate cancer...

<eligibility>
<criteria>
<textblock>Inclusion Criteria: Family
history of prostate cancer...</textblock>
</criteria>
</eligibility>

NA

Eligibility Criteria > Exclusion
Criteria

Patient must not have had radiation
therapy in the pelvic area...

<eligibility>
<criteria>
<textblock>Exclusion Criteria: Patient
must not have had radiation therapy in the
pelvic area...</textblock>
</criteria>
</eligibility>

NA

Intervention(s) > Type

Drug

<intervention_type>Drug</intervention_type>

NA

Intervention(s) > Name

Armodafinil

<intervention_name>Armodafinil<
/intervention_name>

NA

Intervention(s) > Alternate
Name

2-(difluoromethyl)-DL-ornithine, 2(difluoromethyl)-dl-ornithine
Hydrochloride,...

<intervention_other_name>
2-(difluoromethyl)-DL-ornithine,
2-(difluoromethyl)-dl-ornithine
Hydrochloride,...
</intervention_other_name>

NA

Intervention(s) > Description

Given orally

<intervention_description>
<textblock>Given orally</textblock>
</intervention_description>

NA

Arm/Group(s) > Type

Placebo Comparator

<arm_type>Placebo Comparator</arm_type>

NA

Arm/Group(s) > Label

Arm II

<arm_group_label>Arm II</arm_group_label>

NA

Arm/Group(s) > Description

Patients receive oral Armodafinil once
daily...

<arm_group_description>
<textblock>Patients receive oral
Armodafinil once daily...</textblock>
</arm_group_description>

NA

Primary Outcome Measures >
Title

Accrual rate estimated as the number
of patients ...

<primary_outcome>
<outcome_measure>Accrual rate estimated as
the number of patients ...<
/outcome_measure>
</primary_outcome>

NA

Primary Outcome Measures >
Description

Estimated using an analysis of
covariance (ANCOVA) model which
includes...

<outcome_description>
<textblock>Estimated using an analysis of
covariance (ANCOVA) model which includes...
</textblock>
</outcome_description>

NA

Primary Outcome Measures >
Time Frame

Up to 2 years

<outcome_time_frame>Up to 2 years<
/outcome_time_frame>

NA

Secondary Outcome Measures

Incidence of toxicity incidents...

<secondary_outcome>

NA

168

> Title

<outcome_measure>Incidence of toxicity
incidents assessed...</outcome_measure>
<secondary_outcome>

Secondary Outcome Measures
> Description

NA

<outcome_description>

NA

Secondary Outcome Measures
> Time Frame

Up to 2 years

<outcome_time_frame>Up to 2 years<
/outcome_time_frame>

NA

Sub-groups Stratification
Criteria > Label

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Sub-groups Stratification
Criteria > Description

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Marker Name

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Evaluation Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Assay Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Biomarker Use

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Biomarker Purpose

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Markers > Specimen Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol
Abstraction

Participating Sites > Facility

Wake Forest University Health
Sciences

<location>
<facility>
<name>Wake Forest University Health
Sciences</name>
<address>
<city>Winston-Salem</city>
<state>NC</state>
<zip>27106</zip>
<country>United States</country>
</address>
</facility>
</location>

NA

<location>
<contact>
<first_name>Jane</first_name>
<middle_name>M</middle_name>
<last_name>Doe</last_name>
<phone>123-123-1234</phone>
<email>jmd@domain.com</email>
</contact>
</location>

NA

Winston-Salem, NC 27106
United States

Participating Sites > Contact

Doe, Jane, M.
phone:123-123-1234
Email:jmd@domain.com

Participating Sites >
Recruitment Status and Dates

Enrolling by Invitation as of 05/09/2014

<location>
<status>Enrolling by Invitation</status>
</location>

NA

Participating Sites > Target
Accrual

40

(Not included in the XML file)

ClinicalTrials.gov does not
capture this field

Participating Sites >
Investigators

Doe, Jane, Principal Investigator

<investigator>
<first_name>Jane<
/first_name><last_name>Doe<
/last_name><role>Principal Investigator<
/role>
</investigator>

NA

169

Trial Summary Report Data Elements by Section
Each of the following sections contain mapping tables, in the order in which they appear in the TSRs.
For information, refer to the following pages:

170

Trial Identification
TSR Data Elements

XML Data Elements

Trial Category

(Not included in the XML file)

Trial Type

<study_type>

NCI Trial Identifier

<secondary_id>

Other Trial Identifiers

<secondary_id>

Lead Organization (Trial) Identifier

<org_study_id>

ClinicalTrials.gov Identifier

(Not included in the XML file)

DCP Identifier

<secondary_id>

CTEP Identifier

<secondary_id>

CCR Identifier

(Not included in the XML file)

Duplicate NCI Identifier

<secondary_id>

Obsolete ClinicalTrials.gov Identifier

(Not included in the XML file)

Other Identifier

<secondary_id>

Amendment Date

(Not included in the XML file)

Amendment Number

(Not included in the XML file)

171

General Trial Details
TSR Data Elements

XML Data Elements

Type

<study_type>

Official Title

<official_title>

Alternate Title

(Not included in the XML file)

Brief Title

<brief_title>

Acronym

<acronym>

Brief Summary

<brief_summary>

Detailed Description

<detailed_description>

Keywords

<keyword>

Reporting Dataset Method

(Not included in the XML file)

Sponsor

<lead_sponsor>

Lead Organization

<overall_official>

Principle Investigator

<resp_party>

Responsible Party

<resp_party_type>

Overall Official

<overall_official>

Central Contact

<overall_contact>

172

Status/Dates
TSR Data Elements

XML Data Elements

Current Trial Status

<overall_status>

Trial Start Date

<start_date>
<start_date_type>

Primary Completion Date

<primary_compl_date>
<primary_compl_date_type>

Trial Completion Date

<last_follow_up_date>
<last_follow_up_date_type>

173

Regulatory Information/Oversight Information
TSR Data Elements

XML Data Elements

Studies a U.S. FDA-regulated Drug Product

<fda_regulated_drug>

Studies a U.S. FDA-regulated Device Product

<fda_regulated_device>

Unapproved/Uncleared Device?

<delayed_posting>

Post Prior to U.S. FDA Approval or Clearance

<post_prior_to_approval>

Pediatric Post-market Surveillance

<ped_postmarket_surv>

Product Exported from the U.S.

<exported_from_us>

FDA Regulated Intervention?

<is_fda_regulated>

Section 801?

<is_section_801>

DMC Appointed?

<has_dmc>

IND/IDE Study?

<is_ind_study>

174

Human Subject Safety/Regulatory Authority
TSR Data Elements

XML Data Elements

Board Approval Status

<approval_status>

Board Approval Number

<approval_number>

Board

<irb_info>

Affiliation

<affiliation>

175

IND/IDE
TSR Data Elements

XML Data Elements

Type

<ind_info>

Grantor

<ind_grantor>

Number

<ind_number>

Holder Type

(Not included in the XML file)

Holder

(Not included in the XML file)

Availability of Expanded Access

<has_expanded_access>

Expanded Access Record

<expanded_access_nct_id>

176

NIH Grants
TSR Data Elements

XML Data Elements

Funding Mechanism

<secondary_id>

NIH Institute Code

<secondary_id>

Serial Number

<secondary_id>

NCI Division/Program Code

<secondary_id>

177

Data Table 4 Information
TSR Data Elements

XML Data Elements

Funding Category

(Not included in the XML file)

Funding Sponsor/Source

(Not included in the XML file)

Program Codes

(Not included in the XML file)

Anatomic Site Code

(Not included in the XML file)

178

Collaborators
TSR Data Elements

XML Data Elements

Name

<collaborator>

Role

(Not included in the XML file)

179

Disease/Condition
TSR Data Elements
Name

XML Data Elements
<condition>

180

Trial Design
TSR Data Elements

XML Data Elements

Type

<study_type>

Primary Purpose

<interventional_subtype>

Secondary Purpose

(Not included in the XML file)

Phase

<phase>

Interventional Study Model

<assignment>

Model Description

<model_description>

Number of Arms

<number_of_arms>

Masking

<no_masking>
<masked_assessor>
<masked_caregiver>
<masked_investigator>
<masked_subject>

Masking Description

<masking_description>

Allocation

<allocation>

Target Enrollment

<enrollment>

181

Eligibility Criteria
TSR Data Elements

XML Data Elements

Accepts Healthy Volunteers?

<healthy_volunteers>

Sex

<gender>

Gender Based

<gender_based>

Gender Eligibility Description

<gender_description>

Minimum Age

<minimum_age>

Maximum Age

<maximum_age>

Inclusion Criteria

<criteria>

Exclusion Criteria

<criteria>

182

Intervention(s)
TSR Data Elements

XML Data Elements

Type

<intervention_type>

Name

<intervention_name>

Alternate Name

(Not included in the XML file)

Description

<intervention_description>

183

Arm/Group(s)
TSR Data Elements

XML Data Elements

Type

<arm_type>

Label

<arm_group_label>

Description

<arm_group_description>

184

Primary and Secondary Outcome Measures
TSR Data Elements

XML Data Elements

Title

<outcome_measure>

Description

<outcome_description>

Time Frame

<outcome_time_frame>

185

Sub-groups Stratification Criteria
TSR Data Elements

XML Data Elements

Label

(Not included in the XML file)

Description

(Not included in the XML file)

186

Markers
TSR Data Elements

XML Data Elements

Marker Name

(Not included in the XML file)

Evaluation Type

(Not included in the XML file)

Assay Type

(Not included in the XML file)

Biomarker Use

(Not included in the XML file)

Biomarker Purpose

(Not included in the XML file)

Specimen Type

(Not included in the XML file)

187

Participating Sites
TSR Data Elements

XML Data Elements

PO ID

(Not included in the XML file)

Facility

<facility>

Contact

<contact>

Recruitment Status and Dates

<status>

Target Accrual

(Not included in the XML file)

Investigator(s)

<investigator>

188

Excerpts from Example TSR and Example XML File
The images below are excerpts from an example TSR:

189

The images below are excerpts from an example XML file. XML files contain all abstracted data in code format that can be submitted to ClinicalTrials.gov
for registration.

190

191

Trial Types and Subtypes
Trial type refers to the nature of the investigation. The CTRP includes the following types:
Interventional. Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific
interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be
random. The individuals are then followed and biomedical and/or health outcomes are assessed.
Non-Interventional. Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals.
Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the
subjects of the study.
The non-interventional category includes observational and ancillary/correlative studies:
Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants. Biomedical
and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or
other interventions but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the
study.
Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential
causal factor of the condition.
Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other
resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study
and should include only patients accrued to that clinical research study. Report only those studies that can be linked to individual patient
or participant data.
Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only
those studies that can be linked to individual patient or participant data.

192

</pre><Table class="table"><tr><Td>File Type</td><td>application/pdf</td></tr><tr><Td>File Modified</td><td>2019-05-02</td></tr><tr><Td>File Created</td><td>2019-05-02</td></tr></table></div></div></div><hr>
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