Registration Site Users Guide

Attachment_3_INSTRUCT_CTRP Registration_Site_Users_Guide.pdf

The Clinical Trials Reporting Program (CTRP) Database (NCI)

Registration Site Users Guide

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NCI CLINICAL TRIALS
REPORTING PROGRAM
REGISTRATION User’s Guide
SITE 3.1
User’s Guide

Center for Biomedical Informatics
and Information Technology
This is a U.S. Government work.

January 13, 2010

CONTENTS
About This Guide ...................................................................................1
Purpose ................................................................................................................... 1
Audience ................................................................................................................. 1
Topics Covered ...................................................................................................... 1
Additional References ........................................................................................... 2
Text Conventions Used ......................................................................................... 2
Credits and Resources .......................................................................................... 3
Application Support .............................................................................................. 4

Chapter 1
Getting Started ........................................................................................5
About the CTRP Registration Site ....................................................................... 5
What’s New in This Release ........................................................................... 6
Creating an Account ............................................................................................. 6
Logging In to the CTRP Registration Site .......................................................... 8
Using CTRP Trial Registration Templates and Resources ............................ 10
Downloading Trial Registration Templates .............................................. 10
Using the Proprietary Trial Template ........................................................ 11
Using the Participating Sites Template ...................................................... 11
Using the Batch Upload Template .............................................................. 12

Chapter 2
Searching For Trials ..............................................................................15
About Clinical Trial Metadata ........................................................................... 15
Searching For Trials ............................................................................................ 16
Working with Search Results ............................................................................. 18
Navigating Through the Search Results List ............................................. 20
Viewing Trial Details .......................................................................................... 22
Viewing Trial‐Related Documents .............................................................. 24

This is a U.S. Government work.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Chapter 3
Registering New Trials ........................................................................27
Registering Non‐Proprietary Trials in the CTRP Registration Site .............. 27
Editing Trial Details ...................................................................................... 29
Printing Trial Information ............................................................................ 30
Completing the Trial Details Section .......................................................... 31
Completing the Lead Organization/Principal Investigator Section ....... 34
Completing the Sponsor/Responsible Party Section ................................ 35
Completing the Summary 4 Information Section ..................................... 38
Completing the NIH Grant Information Section ...................................... 39
Completing the Trial Status/Dates Section ................................................ 44
Completing the IND/IDE Information Section ......................................... 46
Registering IND Trials .............................................................................. 47
Registering IDE Trials ............................................................................... 49
Completing the Trial Related Documents Section ................................... 51
Registering Proprietary Trials in the CTRP Registration Site ....................... 52
Completing the Trial Identification Section for Proprietary Trials ........ 54
Completing the Trial Details Section for Proprietary Trials ................... 55
Completing Summary 4 Information for Proprietary Trials ................... 56
Completing the Trial Status/Dates Section for Proprietary Trials .......... 57
Completing the Trial Related Documents Section for Proprietary Trials .
57
Registering Organizations .................................................................................. 58
Searching for Registered Organizations .................................................... 59
Adding Organizations .................................................................................. 61
Registering Persons ............................................................................................. 62
Searching for Principal Investigators ......................................................... 63
Adding Principal Investigators ................................................................... 65
Registering Multiple Trials in a Batch .............................................................. 66
Data Requirements for Batch Uploads ....................................................... 68

Chapter 4
Updating and Amending Registered Trials .....................................71
About Trial Updates ........................................................................................... 71
Updating Accepted Trials .................................................................................. 72
About Trial Amendments .................................................................................. 74
Amendment Process Life Cycle .................................................................. 75
Amending Verified Trials .................................................................................. 76
Amending Trial Details ................................................................................ 78
Amending Lead Organization and Principal Investigator Details ........ 78

This is a U.S. Government work.

Amending Sponsor and Summary 4 Details ............................................. 79
Amending NIH Grant Details ..................................................................... 79
Amending Trial Status Dates ....................................................................... 79
Amending IND/IDE Details ......................................................................... 80
Uploading Amendment‐Specific Documents ........................................... 80
Reviewing and Submitting Trial Amendments and Updates ...................... 81
Editing Amended and Updated Details .................................................... 81
Printing Amended and Updated Trial Information ................................. 82

Chapter 5
Managing Your Account ......................................................................83
Managing Your User Account Profile .............................................................. 83
Managing Your Password .................................................................................. 84
Changing Your Password ............................................................................ 84
Resetting Your Password ............................................................................. 84
Transferring Trial Ownership ............................................................................ 85

Appendix A
Batch Upload Data Specifications .....................................................87
Preparing the Trial Data File for Non‐Proprietary Trials .............................. 87
Preparing Trial‐Related Documents ................................................................. 88
Trial Data Element Specifications For Non‐Proprietary Trials ..................... 89
Preparing the Trial Data File for Proprietary Trials ....................................... 90
Trial Specification Rules For Proprietary Trials .............................................. 90

Appendix B
Participating Sites Document Specifications ..................................93
Participating Sites Document Rules .................................................................. 93
Participating Site Data Element Specifications ............................................... 94

Appendix C
Metadata Definitions ...........................................................................95
Glossary ................................................................................................107
Index ......................................................................................................111

This is a U.S. Government work.

iii

NCI CTRP Trial Registration Site v.3.1 User’s Guide

This is a U.S. Government work.

ABOUT THIS GUIDE
This section introduces you to the NCI CTRP Trial Registration Site v.3.1 User’s Guide.
It includes the following topics:


Purpose



Audience



Topics Covered



Additional References



Text Conventions Used



Credits and Resources



Application Support

Purpose
This guide provides an overview of the NCI Clinical Trials Reporting Program Trial
Registration Site (CTRP Registration Site) and instructions for using its tools and
resources to search for and view details of existing clinical trials. Additionally, registered
users can submit new clinical trials and amend and/or update those currently registered
and verified in the CTRP.

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

Topics Covered
If you have worked with previous versions of NCI Clinical Trials Reporting Program
Trial Registration Site, see Additional References on page 2.
If you are new to NCI Clinical Trials Reporting Program Trial Registration Site, read this
brief overview, which explains what you will find in each chapter and appendix.


Chapter 1, Getting Started, on page 5 introduces you to the CTRP Registration
Site and provides instructions for registering for an account and for logging in to
the system.
1

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Chapter 2, Searching For Trials, on page 15 describes how to search for,
submit, and view trials in the CTRP Registration Site.
Chapter 3, Registering New Trials, on page 27 describes how to submit, or
register, trials using the CTRP Registration Site.
Chapter 4, Updating and Amending Registered Trials, on page 71 describes
how to update and make amendments to trials currently registered and verified
in the CTRP.
Chapter 5, Managing Your Account, on page 83 provides instructions for
modifying your CTRP Registration Site account, resetting your password, and
transferring trial ownership.
Appendix A, Batch Upload Data Specifications, on page 87 describes how to
prepare your trial data and documents. It also provides data specifications for
the trial data.
Appendix B, Participating Sites Document Specifications, on page 93 provides
the specifications—rules, formats, requirements, etc.—for Participating Sites
documents.
Appendix C, Metadata Definitions, on page 95 defines the metadata associated
with trials and provides examples of valid values for trial details.

Additional References
For more information about the NCI Clinical Trials Reporting Program Trial Registration
Site, clinical trial protocols, and terminology, see the following references:


Clinical Trials Reporting Program (http://www.cancer.gov/ncictrp)



ClinicalTrials.gov (http://clinicaltrials.gov)



PRS and U.S. Public Law 110-85 (http://prsinfo.clinicaltrials.gov/fdaaa.html)



Glossary of CTRP Terms (http://www.cancer.gov/clinicaltrials/ctrp/page12)



Dictionary of Cancer Terms (http://www.cancer.gov/dictionary/
db_alpha.aspx?expand)
CinicalTrials.gov XML File Upload Instructions (http://www.cancer.gov/
clinicaltrials/ctrp/page11)

Text Conventions Used
This section explains conventions used in this guide. The various typefaces represent
interface components, keyboard shortcuts, toolbar buttons, dialog box options, and text
that you type.

Convention

Description

Example

Bold

Highlights names of option buttons, check
boxes, drop-down menus, menu
commands, command buttons, or icons.

Click Search.

About This Guide

Convention

Description

Example

URL

Indicates a Web address.

http://domain.com

text in SMALL CAPS

Indicates a keyboard shortcut.

Press ENTER.

text in SMALL CAPS +
text in SMALL CAPS

Indicates keys that are pressed
simultaneously.

Press SHIFT +
CTRL.

Italics

Highlights references to other documents,
sections, figures, and tables.

See Figure 4.5.

Italic boldface
monospaced type

Represents text that you type.

In the New Subset
text box, enter

Proprietary
Proteins.
Note:

{ }

Highlights information of particular
importance

Note: This concept
is used throughout
the document.

Surrounds replaceable items.

Replace {last name,
first name} with the
Principal
Investigator’s name.

Credits and Resources
The following people contributed to the development of this document.
Role

Name

Affiliation

Program Officer

John Speakman

NCI-CBIIT

Program Officer

Christo Andonyadis

NCI-CBIIT

Technical Project Manager

Steve Silberman

SAIC-Frederick

Project Manager

Edmond Mulaire

SemanticBits

Architect

Todd Parnell

5AM Solutions

Lead Analyst

Smita Hastak

ScenPro

Analyst

Nelli Shimko

ScenPro

Analyst

Gia Wood

ScenPro

Tech Lead for PA

Naveen Amiruddin

ScenPro

Tech Lead for Accruals

Hugh Reinhart

ScenPro

Tech Lead for Curation and Grid Services

Steve Lustbader

5AM Solutions

Developer

Anupama Sharma

ScenPro

Developer

Vrushali Niktie

5AM Solutions

Developer

Max Shestopalov

5AM Solutions

Developer

Steve Matyas

5AM Solutions

Developer

Rajani Babulingam

NTVI

Table 3.1 NCI‐CTRP technical and domain experts listed by role

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Role

Name

Affiliation

Developer

Kalpana Guthikonda

ScenPro

Developer

Lisa Kelley

ScenPro

Developer

Christophe Ludet

ScenPro

Developer

Krishna Kanchinadam

5AM Solutions

Technical Writer

Lauren Anthone

Lockheed Martin

QA Team Lead

Paula Brown

Ekagra

QA Engineer

Sohal Shah

Ekagra

Table 3.1 NCI‐CTRP technical and domain experts listed by role (Continued)

Application Support
If you have questions or comments regarding this document, or other CTRP topics,
contact the CTRP as per the instructions below.
Email: [email protected]

When submitting support requests via email,

(mailto:[email protected]) include the following:



Your contact information, including your
telephone number.



The name of the application/tool you are
using



The URL if it is a Web-based application



A description of the problem and steps to
recreate it.



The text of any error messages you have
received

C HA PTE R

GETTING STARTED
This chapter introduces you to the NCI Clinical Trials Reporting Program Trial
Registration Site (CTRP Registration Site) and provides instructions for registering for
an account and for logging in to the system.
This section includes the following topics:


About the CTRP Registration Site



Creating an Account



Logging In to the CTRP Registration Site



Using CTRP Trial Registration Templates and Resources

About the CTRP Registration Site
The CTRP Registration Site provides researchers with access to cancer clinical trials. It
enables users to search for clinical trials submitted by members of the cancer research
community and to view details of existing trials. Additionally, users who create an
account with the CTRP can submit new clinical trial protocol details and amend those
currently registered and verified in the CTRP.
The CTRP Registration Site enables users to register, amend, and update trials one-ata-time, or in batches consisting of multiple trials. For information on registering single
trials, see Chapter 3, Registering New Trials, on page 27. For information on
registering multiple trials, see Registering Multiple Trials in a Batch on page 66.
Currently you can register proprietary and non-proprietary interventional trials. Future
releases of this product will enable you to register observational trials as well.
Note: CTRP Registration Site supports Internet Explorer 7 (IE 7.0.5730.13 and 7.0.5730.11), IE
8 (8.0.6001.18702), and FireFox 3 (3.0.10) browsers.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Related topics:


Creating an Account on page 6



Logging In to the CTRP Registration Site on page 8



What’s New in This Release on page 6



Using CTRP Trial Registration Templates and Resources on page 10

What’s New in This Release
CTRP Registration Site version 3.1 has the following new features:


User-friendly web-based interface for registering/reregistering propriety trials



Multiple proprietary trial registration via batch upload



Non-proprietary trial update via the user interface



Multiple non-proprietary trial updates and amendments via batch upload



Trial search by the principal investigator’s name



Trial search by amendment processing status



Trial Summary Report enabled for change-tracking in MS Word



Trial details include trial ownership and category

Related topics:


Creating an Account on page 6



Logging In to the CTRP Registration Site on page 8



Using CTRP Trial Registration Templates and Resources on page 10

Creating an Account
To search for and submit individual clinical trial protocol details, create an account with
the CTRP using the account feature in the CTRP Registration Site. Additionally, you
can request authorization from the CTRP to use the batch upload feature to register,
update, and amend multiple new trials that were conducted at a given site. Follow
instructions in Registering Multiple Trials in a Batch on page 66
Note: You must provide, and have access to, a valid email address to create an
account.
How to Register as a New User
1. Navigate to the CTRP Registration Site home page at:
http://trials.nci.nih.gov/registration
2. On the navigation pane on the left side of the page (Figure 1.1), click Create
Account.

Chapter 1 Getting Started

Figure 1.1 Navigation Pane
The Create Account page appears (Figure 1.2).

Figure 1.2 CTRP Registration Site – Create Account Page
3. Type a valid email address and password in the fields provided. Passwords
must contain a minimum of the following characters:
o

Six characters

One numeric character (e.g. 1,2,3)

4. Re-type your password in the field provided.
5. Click Submit.
A message appears indicating that the system has sent a confirmation email to
the email address you provided.
6. Open the confirmation email and click the embedded link to confirm your
registration.
The My Account page appears. The Email Address, Password, and Re-type
Password fields are pre-populated with the information you provided.
Note: Contact information is required for internal administrative use only.
Your information is not revealed to the public.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Figure 1.3 My Account Page
7. Complete the remaining personal information fields. Provide your professional
information only. An asterisk (*) beside a field indicates that the information is
required.
Note: If the address you provide is outside of the United States, select the State
option None (International).
8. In the Organization Affiliation field, type the name of the organization you are
affiliated with.
9. In the PRS Organization Name field, type the name of the organization as it is
registered in the ClinicalTrials.gov Protocol Registration System.
10. Click Submit.
Related topics:


Logging In to the CTRP Registration Site



Transferring Trial Ownership on page 85



What’s New in This Release



Using CTRP Trial Registration Templates and Resources



Managing Your User Account Profile



Resetting Your Password



Searching For Trials

Logging In to the CTRP Registration Site
Once you have created a CTRP Registration Site account, you can log in to search for
and submit clinical trial details.

Chapter 1 Getting Started

Tip:

Gather all the protocol data you need before you begin. The system logs you out if it
detects that you have not used the application for 90 minutes.
How to Log In to the CTRP Registration Site
1. Navigate to the CTRP Registration Site home page at:
http://trials.nci.nih.gov/registration
2. Do one of the following to access the login page:
o

On the navigation pane on the left side of the page (Figure 1.4), click Login.

- or o

On the banner at the top of the page on the right side, click Login.

Figure 1.4 Navigation Pane
The Login page appears (Figure 1.5).

Figure 1.5 CTRP Registration Site – Login page
3. Type the email address and password you registered earlier. See Creating an
Account for more information on creating a user account.
Note: If you have forgotten your password, see the instructions in Resetting
Your Password on page 84.
4. Click Login.
The notification regarding respondent burden appears.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

5. After you read the public reporting burden notice, click Accept.
The Search Trials page appears.
After you have logged in to CTRP Registration Site, you can proceed to search for and/
or add clinical trials in the system.
Related topics:


Resetting Your Password on page 84



Searching For Trials on page 16



Viewing Trial Details on page 22



Registering Non-Proprietary Trials in the CTRP Registration Site on page 27



About the CTRP Registration Site on page 5

Using CTRP Trial Registration Templates and Resources
The CTRP provides templates and other resources on their website that you can use to
facilitate trial information gathering, registration, update, and amendment. Additionally,
a template is available to guide you through the process of registering multiple trials at
one time using the CTRP Registration Site’s batch upload feature. CTRO staff use the
information you provide in these documents to abstract your trials.
Instructions, rules, valid values, and specifications for using each of the templates are
provided in the template files.
Tip:

Refer to the glossary of CTRP terms at http://www.cancer.gov/clinicaltrials/ctrp/
page12, or the Glossary in this guide to help you to understand all the data elements
required.
Related topics:


Downloading Trial Registration Templates on page 10



Using the Proprietary Trial Template on page 11



Using the Participating Sites Template on page 11



Using the Batch Upload Template on page 12

Downloading Trial Registration Templates
You can download the following templates (MS Excel files) from the CTRP website
(http://www.cancer.gov/clinicaltrials/ctrp/page11):


Non-proprietary trial templates:
o

CTRP Registry non-Proprietary Batch Upload Template. Use this
template as a guide to record trial data required for registering multiple nonproprietary trials, updates, and amendments in batches.

CTRP Registry non-Proprietary Participating Sites Template. Use this
template to record interventional trial participating site data, especially if

Chapter 1 Getting Started

site-specific data is not included in the trial protocol, or if you need to make
changes to the original participating sites information.
Note: For information about trial updates and amendments, see Updating and
Amending Registered Trials on page 71.


Proprietary trial templates:
o

CTRP Registry Proprietary Batch Upload Template. Use this template as
a guide to record trial data required for registering multiple proprietary trials.

CTRP Registry Proprietary Participating Sites Template. Use this
template to record interventional proprietary trial participating site data.

How to Download CTRP Templates
1. On the navigation pane, click Useful Templates and Documentation.
The NCI CTRP website Resources page appears in a new browser window.
2. Click the link for the document you want to download.
3. Save the file to your local hard drive.
Note: If you have difficulty locating or downloading the templates, send a request for the
files to application support at mailto:[email protected].
Related topics:


Using the Proprietary Trial Template on page 11



Using the Participating Sites Template on page 11



Using the Batch Upload Template on page 12

Using the Proprietary Trial Template
The proprietary trial template is designed primarily for submitting multiple industry-lead
trials with contractual obligations that restrict sharing of their protocol documents.
You must email the completed trial Proprietary template to the CTRO staff, who will
then register your trials using the data you provided.
Tip:

You can use the same template to add participating site information to a proprietary
trial that a different participating site has already registered.
Related topics:


Downloading Trial Registration Templates on page 10



Using the Participating Sites Template on page 11



Using the Batch Upload Template on page 12

Using the Participating Sites Template
The participating sites template is designed for recording participating site data for
interventional non-proprietary trials, especially if site-specific data is not included in the

NCI CTRP Trial Registration Site v.3.1 User’s Guide

trial protocol. The participating site document includes participating site information and
collaborator information. See Participating Sites Document Specifications on page 93.
Rules for completing participating site documents are as follows:


The collaborators information is optional



Participating site information must include the following data elements:
o

Study participating site data

At least one study site investigator's information

Participating site primary or central contact information

Note: Generic contact information is accepted




Participating site data must include the following data elements:
o

Organization attribute

Current recruitment status

Status date

Target accrual. This is mandatory if the target accrual is for a study at a
participating site or if the lead organization is a Cancer Center.

Study site investigator's information must include the following data elements:
o

Study site investigator data with person's attributes

Investigator's role in the study at the site

Note: When registering multiple investigators for a single trial, create one line
per investigator/site, using the participating site number as reference.




Participating site contact information is optional if the contact person is the
investigator, or if the central contact information is provided
If the contact person is the investigator, the participating site data and study site
investigator's information are mandatory

Related topics:


Downloading Trial Registration Templates on page 10



Using the Proprietary Trial Template on page 11



Using the Batch Upload Template on page 12

Using the Batch Upload Template
The Batch Upload Template contains the trial elements required for registering,
updating, and amending trials, provided in the order in which you should list them. It
also contains instructions for preparing the trial documents for submission, valid values
for key data elements, and an example of a completed batch upload file. For further
details, see Batch Upload Data Specifications on page 87.

Chapter 1 Getting Started

Related topics:


Downloading Trial Registration Templates on page 10



Using the Proprietary Trial Template on page 11



Using the Participating Sites Template on page 11

NCI CTRP Trial Registration Site v.3.1 User’s Guide

C HA PTE R

SEARCHING FOR TRIALS
This chapter describes how to search for existing trials in the CTRP Registration Site.
This chapter includes the following topics:


About Clinical Trial Metadata



Searching For Trials



Working with Search Results



Viewing Trial Details

About Clinical Trial Metadata
The CTRP Registration Site captures trial details, or metadata, as entered by a trial
protocol submitter. This metadata enables the research community to share common
elements. Appendix C, Metadata Definitions, on page 95 describes the metadata
associated with trials and provides examples of valid values.
As a CTRP account holder, you can search for and review a subset of registered data
that has been submitted and validated.
Related topics:


Searching For Trials



Registering Non-Proprietary Trials in the CTRP Registration Site



About the CTRP Registration Site



Creating an Account



Working with Search Results



Viewing Trial Details

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Searching For Trials
You can retrieve existing trials through the CTRP Registration Site once you have
registered for an account. See Creating an Account on page 6.
Note: You can search the registration information for all trials registered with the CTRP from
all organizations/accounts, or, you can limit your search to the trials that you have
submitted by using the Search My Trials feature. For details, see step 3 on page 18. All
registered users can search trials with the “Validated” processing status. Additionally,
you can search trials that you registered which have not been validated. These trials are
indicated by the “Submitted” status.
How to Search For Existing Trials
1. On the navigation pane on the left side of the page, click Search Trials.
The Search Trials page appears (Figure 2.1).

Figure 2.1 Search Trials Page
2. Provide one or more search criteria for the trials you want to retrieve, or, to
display a list of all trials that have been submitted, leave all fields blank and click
Search All Trials.
Table 2.3 lists the available search criteria. When viewing this guide online, click
a hyperlinked term to see its definition.
To search by this...

Do this...

Title

Type one or more words from the long title or name of the trial
provided by the principal investigator or sponsor.

Table 2.1 Trial Search Criteria

Chapter 2 Searching For Trials

To search by this...

Do this...

Phase

Select the trial phase from the drop-down menu.

Purpose

Identifier Type



Phase 0



Phase I



Phase I/II



Phase II



Phase II/III



Phase III



Phase IV



Pilot



N/A



Other

Select the primary purpose of the trial from the drop-down
menu.


Treatment



Prevention



Diagnostic



Early Detection



Supportive Care



Epidemiologic



Screening



Health Services Research



Basic Science



Observational



Outcome



Ancillary



Correlative



Interventional



Other – Any other type of trial not included in this list

Select the type of trial identifier from the drop-down list.


NCI – National Cancer Institute



NCT – National Clinical Trial identifier (NCT Number)



Lead Organization

Identifier

Type the unique identifier assigned to the trial by the NCI,
NCT, PRS, or the identifier assigned to it by the lead
organization. For Inter-Group trials, type the Lead Group’s
trial number.

Organization Type

Select either Lead Organization or Participating Site from the
drop-down list.

Organization

Type the initial letter(s) of your organization and then select
the name of your organization from the drop-down list.

Table 2.1 Trial Search Criteria (Continued)

NCI CTRP Trial Registration Site v.3.1 User’s Guide

To search by this...

Do this...

Principal
Investigator

Select the principal investigator’s name from the drop-down
list.

Table 2.1 Trial Search Criteria (Continued)
3. Do one of the following:
o

To search all registered trials in the system, click Search All Trials.

-or o

To search only the trials that you submitted previously, click Search My
Trials.

-or o

To clear all search criteria and begin a new search, click Reset.

The Search Trials page refreshes and displays a list of search results. For more
information on navigating and working with search results, see Working with
Search Results.
Tip:

You can create more space on your monitor for the search results list by
hiding the search fields. To do so, select the Hide Search Fields check
box at the top left side of the search criteria section.

4. To view the trial, click the link corresponding to the NCI Trial Identifier.
The Trial Details page appears. For more information on viewing trial details,
see Viewing Trial Details.
Related topics:


About Clinical Trial Metadata



Registering Non-Proprietary Trials in the CTRP Registration Site



About the CTRP Registration Site



Creating an Account



Working with Search Results



Viewing Trial Details

Working with Search Results
The Clinical Trials Reporting Office (CTRO) reviews, or validates each trial submitted to
the system. During the validation process, these reviewers check for duplicate records
and ensure that the submitter has provided all required information. If all data is
complete and accurate, the reviewers assign the trial a status of “accepted,” and the
CTRO notifies you by email. Otherwise they assign the status “rejected.” In the event
that your submission is “rejected,” the CTRO sends you an email message indicating
the status and reason for the rejection.

Chapter 2 Searching For Trials

Note: If notified about a rejected trial, review the accuracy of their submissions, make
adjustments, and re‐submit the trial, if applicable. Submitters may also contact NCICB
Application Support for additional assistance, as necessary. See Application Support on
page 4.
The search returns results and displays them according to the following criteria:


Processing status of the trial at the time of the search



User's role with respect to the trial



Trial ownership

User roles include the following:


Submitter – User who submitted the trial



Other user – Any user other than the submitter

Trial ownership categories are as follows:




Private trials – Trials submitted by the user who is currently logged in to the
CTRP Registration Site
Public trials – Trials submitted by other registered users

Table 2.2 provides definitions for each of the processing statuses and indicates which
ones will be displayed for different user roles.
Note: Only trials that you submitted display a status in the search results list.
Processing
Definition
Status

Which roles can
see this trial in
the list?

Listed in
“My Trials?”

Submitted

Original trial submitted but not validated

Submitter

Yes

Amendment
Submitted

Amendment submitted but not validated



Submitter



Other users

Accepted

Trial passed validation



Submitter



Other users

Rejected

Trial did not pass validation

No one

Abstracted

Trial has been abstracted



Submitter



Other users

Verification
Pending

Trial has been abstracted, and the
TSR has been sent to the trial
submitter for abstraction verification



Submitter



Other users

Abstraction
Verified
Response

Submitter has verified the abstraction
as per the TSR, and has returned
feedback to the CTRO within the
allowed time frame



Submitter



Other users

Yes
Yes
No
Yes
Yes

Yes

Table 2.2 Processing statuses of trials in the CTRP Registration Site

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Processing
Definition
Status
Abstraction
Verified No
Response

Submitter has not returned
verification feedback to the CTRO
within the allowed time frame

Which roles can
see this trial in
the list?


Submitter



Other users

Listed in
“My Trials?”
Yes

Table 2.2 Processing statuses of trials in the CTRP Registration Site (Continued)
Related topics:


Navigating Through the Search Results List



About Clinical Trial Metadata



Registering Non-Proprietary Trials in the CTRP Registration Site



About the CTRP Registration Site



Creating an Account



Searching For Trials



Viewing Trial Details

Navigating Through the Search Results List
After you search for trials, a list of search results and their associated trial details
appears at the bottom of the Search Trials page (Figure 2.2).

Figure 2.2 Search Results List
Search results display the following information about each trial:


NCI Trial Identifier – Unique identifier assigned to the trial by the CTRP.



Title



Current Trial Status – Code that represents the status of a trial in relation to the
ability to enroll participants/patients.
Lead Organization – Organization responsible for the overall scientific and
administrative coordination, study monitoring, and data management activities
of a given clinical trial
Lead Organization Trial Identifier – Unique identification assigned to the
protocol by the lead 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.

Chapter 2 Searching For Trials



Principal Investigator – Appointed investigator responsible for conducting
clinical trial, or for multi-site trials, the study chair
Current Processing Status – Position of the trial with respect to the abstraction
process life cycle.
Update – Indicates when a registered trial has been accepted or otherwise
processed sufficiently to receive updates.
Amend – Indicates when the trial has been processed sufficiently to receive
amendments.

You can navigate through the search results in several ways, as detailed in Table 2.3.
To do this...

Do this...

Additional Notes

Sort your results by column

Click the column heading.

By default, results are sorted
by NCI Trial Identifier.

Move to the next page of
results

Click Next or click the next
page number above or below
the list of results.

The Next link is not active on
the last page of results.

Move to the previous page of
results

Click Prev or click the
preceding page number
above or below the list of
results.

The Prev link is not active on
the first page of results.

Move to a specific page of
results

Click the specific page
number above or below the
list of results.

None

Move to the first page of
results

Click First above or below the
list of results.

The First link is not active on
the first page of results.

Move to the last page of
results

Click Last above or below the
list of results.

The Last link is not active on
the last page of results.

View details for a trial

Click the NCI Trial Identifier
for the trial of interest. The
Trial Details page appears.

As a registered user, you can
view details for accepted trials
that have been submitted by
others. Additionally, you can
view all trials that you have
submitted that have not been
rejected during the validation
process.

Download trial-related
documents

Click the name of the trial
document.

Only submitters can view/
download trial-related
documents.

Table 2.3 Methods for viewing search results and trial details
Related topics:


About Clinical Trial Metadata



Registering Non-Proprietary Trials in the CTRP Registration Site



About the CTRP Registration Site

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Creating an Account



Working with Search Results



Viewing Trial Details

Viewing Trial Details
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 trial ownership and trial category. Trials
can be public or private, and proprietary or non-proprietary. The following table lists
available trial details by ownership and category. An “X” in a column indicates that the
given trial detail is provided.
Trial Details

Non-Proprietary Trials

Proprietary Trials

Private

Public

Private

Public

NCI Trial Identifier

NCT Number

Amendment Date

Amendment Number

Lead Organization Trial
Identifier

Official Title

Trial Type

Primary Purpose

Phase

Sponsor/Responsible
Party

Sponsor

Responsible Party

Lead Organization/
Principal Investigator

Lead Organization

Principal Investigator

Summary 4 Information

Summary 4 Funding
Category

Summary 4 Funding
Source/Sponsor

NIH Grant Information

Table 2.4 Trial details provided for public and private proprietary
and non‐proprietary trials
22

Chapter 2 Searching For Trials

Trial Details

Non-Proprietary Trials
Private

Public

Funding Mechanism

NIH Institution Code

Serial Number

NCI Division/Program

Status/Dates

Proprietary Trials
Private

Public

Current Recruitment
Status

Current Recruitment
Status Date

Opened for Accrual

Closed for Accrual

Current Trial Status

Current Trial Status Date

Trial Start Date

Type

Primary Completion
Date

Type

IND/IDE Information

IND/IDE Protocol?

IND Type

IND Number

IND Grantor

IND Holder Type

Holder-NIH Institution/
NCI Division/Program
(please specify)

Has Expanded Access?*

Expanded Access
Status

Trial Related Documents

Protocol Document*

IRB Approval*

Participating Sites

Informed Consent

Table 2.4 Trial details provided for public and private proprietary
and non‐proprietary trials (Continued)
23

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Trial Details

Non-Proprietary Trials
Private

Related topics:


Completing the Trial Identification Section for Proprietary Trials on page 54



Registering Proprietary Trials in the CTRP Registration Site on page 52



Completing Summary 4 Information for Proprietary Trials on page 56



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Related Documents Section for Proprietary Trials on page
57

Completing Summary 4 Information for Proprietary Trials
Instructions for completing the Summary 4 Information section are the same for both
proprietary and non-proprietary trials. See Completing the Summary 4 Information
Section on page 38.
Related topics:


Completing the Trial Identification Section for Proprietary Trials on page 54



Completing the Trial Details Section for Proprietary Trials on page 55



Registering Proprietary Trials in the CTRP Registration Site on page 52



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Related Documents Section for Proprietary Trials on page
57

Chapter 3 Registering New Trials

Completing the Trial Status/Dates Section for Proprietary Trials
You must complete all fields in the Status/Dates section that are marked with an
asterisk (*). If you provide a Closed for Accrual date, you must also provide an Opened
for Accrual date.

Figure 3.23 Add Trial Page – Status/Dates Section
How to Complete the Status/Dates Section
1. From the Site Current Recruitment Status field, select the trial’s current
recruitment status.
2. If applicable, in the Date Opened for Accrual field, type the date on which
accrual started, using the date format mm/dd/yyyy, or, click the calendar icon
( ) and select the date from the calendar.
3. If applicable, in the Date Closed for Accrual field, type the date on which
accrual ended, using the date format mm/dd/yyyy, or, click the calendar icon
( ) and select the date from the calendar.
Related topics:


Registering Proprietary Trials in the CTRP Registration Site on page 52



Completing the Trial Details Section for Proprietary Trials on page 55



Completing Summary 4 Information for Proprietary Trials on page 56



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Identification Section for Proprietary Trials on page 54



Completing the Trial Related Documents Section for Proprietary Trials on page
57

Completing the Trial Related Documents Section for Proprietary Trials
You must include a proprietary template if you did not provided an NCT number in the
Trial Identification section. Currently you are required to supply your documents as
Microsoft Word (.doc, .docx, or .docm), Adobe PDF, Microsoft Excel (.xls, .xlsx,
.xlsm, or .xlsb), and/or WordPerfect files.
See Using the Proprietary Trial Template on page 11 for template instructions and
download details.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Figure 3.24 Add Trial Page – Trial Related Documents
Note: The procedure for uploading documents is the same for all document types.
How to Submit Trial Related Documents
1. Next to the Proprietary Template field, click Browse.
2. Navigate to, and select, the appropriate document, and then click Open.
Note: Depending on your operating system, you may see a different command
name for “Open.”
3. Repeat the steps above for any other document you want to submit.
Related topics:


Completing the Trial Identification Section for Proprietary Trials on page 54



Completing the Trial Details Section for Proprietary Trials on page 55



Completing Summary 4 Information for Proprietary Trials on page 56



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Completing the Trial Status/Dates Section for Proprietary Trials on page 57



Registering Proprietary Trials in the CTRP Registration Site on page 52

Registering Organizations
You can register an organization if you are unable to find your organization listed in the
system. Before you register an organization, be sure to search the system’s registered
organizations to ensure that you do not create a duplicate record. (See Searching for
Registered Organizations on page 59.) If your search results do not contain the name
of your organization, you can register a new one. (See Adding Organizations on
page 61.)
Related topics:



Searching for Registered Organizations on page 59



Adding Organizations on page 61



Registering Persons on page 62



Searching for Principal Investigators on page 63

Chapter 3 Registering New Trials



Adding Principal Investigators on page 65

Searching for Registered Organizations
If you are unsure of the name of the lead organization for a trial that you are registering,
you can search for organizations in the system and select the correct one from a list of
search results.
Note: The instructions provided below are for searching for a Lead Organization. Use the
same instructions for searching for Sponsors and Summary 4 Funding Sponsor/
Sources.
How to Search for Registered Organizations
1. On the navigation pane, click Register Trial, and then navigate to the Lead
Organization/Principal Investigator section.

Figure 3.25 Lead Organization/Principal Investigator Section
2. Next to the Lead Organization field, click Look Up.
The Search Organizations window appears.

Figure 3.26 Search Organizations Window
3. Provide as much information as you can about your organization. For example,
if you know just the city location, type it in the City field. If you search by CTEP
Identifier, you must provide the entire identifier.
Tip:

You can type a series of characters in the Name, City, or Zip fields to
narrow the search results. Because the system adds wildcards for you, do
not type wildcard symbols in the search fields.

Note: You must enter search criteria in at least one field.
4. Click Search.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

The Search Organizations window displays the results of your search.

Figure 3.27 Search Organizations Window – Search Results
Tip:

If your 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 yours, you can narrow your search by
providing more information. Refer to Step 5 for instructions.

5. If your organization was not listed, do one of the following to modify your
search:
o

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 o

To narrow your search so that fewer organizations are listed in the search
results, provide more information about your organization. For example, if
you searched by organization name only in your original search, you may
want to search by city in addition to the name.

6. Click Search.
The Search Organizations window displays the results of your new search. See
Figure 3.27, Search Organizations Window – Search Results, on page 60.
7. Scroll through the results list until you locate your organization, and then click
Select.
The organization name you selected appears in the Lead Organization field in
the Lead Organization/Principal Investigator section.
If you don’t find your organization in the system, you can register it as a new one. For
instructions, see Adding Organizations on page 61.

Chapter 3 Registering New Trials

Related topics:


Registering Organizations on page 58



Adding Organizations on page 61



Registering Persons on page 62



Searching for Principal Investigators on page 63



Adding Principal Investigators on page 65

Adding Organizations
If your organization is not currently registered in the system, you can register it at the
same time you register your trial. Be sure to search the system’s registered
organizations first before you register a new one. This will ensure that you do not create
a duplicate record in the system.
Note: The instructions provided below are for registering a Lead Organization. Use the same
instructions for registering Sponsors and Summary 4 Funding Sponsor/Sources.
How to Register an Organization
1. On the navigation pane, click Register Trial, and then navigate to the Lead
Organization/Principal Investigator section.

Figure 3.28 Lead Organization/Principal Investigator Section
2. Next to the Lead Organization field, click Look Up.
The Select Lead Organization page appears.

Figure 3.29 Select Lead Organization Page
3. Click Add Org.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

The Add Organization window appears.

Figure 3.30 Add Organization Window
4. In the Organization Name field, type the full name of your organization.
5. Provide information in all required fields—those marked with an asterisk (*), and
then click Save.
Your new organization is saved in the system and appears below the
information you provided.
6. Click Select.
The Organization Name field is populated with the name you just registered.
Related topics:


Registering Organizations on page 58



Searching for Registered Organizations on page 59



Registering Persons on page 62



Searching for Principal Investigators on page 63



Adding Principal Investigators on page 65

Registering Persons
You can register an investigator if you are unable to find the person listed in the system.
Before you register an investigator, be sure to search the system’s registered
investigators to ensure that you do not create a duplicate record. (See Searching for
Principal Investigators on page 63.) If your search results do not contain the name of
your investigator, you can register a new one. (See Adding Principal Investigators on
page 65.)
Related topics:



Registering Organizations on page 58



Adding Organizations on page 61



Searching for Principal Investigators on page 63



Adding Principal Investigators on page 65

Chapter 3 Registering New Trials

Searching for Principal Investigators
If you are unsure of the name of the principal investigator for the trial that you are
registering, you can search for one in the system and select the correct one from a list
of search results.
Tip:

If you don’t find your investigator in the system, you can register it as a new one. For
instructions, see Adding Principal Investigators on page 65.
How to Search For Principal Investigators
1. On the navigation pane, click Register a Trial, and then navigate to the Lead
Organization/Principal Investigator section.

Figure 3.31 Lead Organization/Principal Investigator Section
2. Next to the Principal Investigator field, click Look Up.
The Select Principal Investigator page appears.

Figure 3.32 Select Principal Investigator Page – Search Persons
3. Provide as much information as you can about your investigator.
Tip:

You can type a series of characters in either of the Name fields to narrow
the search results. Because the system adds wildcards for you, do not
type wildcard symbols in the search fields.

Note: You must enter search criteria in at least one field.
4. Click Search.
The Select Principal Investigator page displays the results of your search.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Figure 3.33 Principal Investigator Lookup Page – Search Results (partially redacted)
Tip:

If your principal investigator is not listed, you may have searched too
narrowly (i.e. 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 yours, you can narrow your search by providing more
information. Refer to Step 5 for instructions.

5. Scroll through the results list until you locate your principal investigator, and
then click Select. The investigator’s name you selected appears in the
Principal Investigator field in the Lead Organization/Principal Investigator
section.
6. If your investigator was not listed, modify your search as follows:
o

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 part of
the person’s names, email address, and CTEP Identifier in your original
search, you may want to search by last name alone.

- or o

To narrow your search so that fewer names are listed in the search results,
provide more about your investigator. For example, if you searched by last
name only in your original search, you may want to search by CTEP
Identifier.

7. Click Search, and then repeat Step 5.
Related topics:



Registering Organizations on page 58



Adding Organizations on page 61



Registering Persons on page 62



Searching for Principal Investigators on page 63

Chapter 3 Registering New Trials



Adding Principal Investigators on page 65

Adding Principal Investigators
If your trial’s principal investigator’s name is not currently registered in the system, you
can register it at the same time you register your trial. Be sure to search the system’s
registered names first before you register a new one. This will ensure that you do not
create a duplicate record in the system.
How to Register a Principal Investigator
1. On the navigation pane, click Register Trial, and then navigate to the Lead
Organization/Principal Investigator section.

Figure 3.34 Lead Organization/Principal Investigator Section
2. Next to the Principal Investigator field, click Look Up.
The Select Principal Investigator page appears.

Figure 3.35 Select Principal Investigator Page – Search Persons
3. Click Add Person.
The Add Person window appears.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Figure 3.36 Add Person Window
4. Type or select as much information as possible in the fields provided. Use
professional contact information only. You must complete all required fields,
marked with an asterisk (*).
Note: The information you provide is not revealed to the public.
5. Click Save.
6. Your new investigator is saved in the system and the Principal Investigator
field on the Register Trial page is populated with the name you just registered.
Related topics:


Registering Organizations on page 58



Adding Organizations on page 61



Registering Persons on page 62



Searching for Principal Investigators on page 63

Registering Multiple Trials in a Batch
Before you begin, you must request authorization from the CTRP to upload batches of
trials. To request authorization, submit a request to the Help Desk via email addressed
to: [email protected].
As an authorized CTRP submitter you can use the CTRP Registration Site’s batch
upload feature to register multiple new non-proprietary trials that were conducted at a
given site.
Note: The CTRP provides you with the link to the batch upload website when it issues
authorization to upload batches.
In the current release, you can supply a maximum of 5 trial documents.
66

Chapter 3 Registering New Trials

You must upload each of the following types of files when you register multiple trials:


Data documents – Documents that contain all the requisite information about
the protocol. See Data Requirements for Batch Uploads on page 68 and
Appendix A, Batch Upload Data Specifications, on page 87.
o



Format: Microsoft Excel file ({filename}.xls)

Trial-related documents – Protocol and IRB documents, among others.
o

Format: compressed Word files ({filename}.zip)

Note: Currently you are required to supply your documents as compressed
Microsoft Word (.doc, .docx, or .docm), Adobe PDF, Microsoft Excel
(.xls, .xlsx, .xlsm, or .xlsb), and/or WordPerfect files.
How to Upload a batch of trials
1. Navigate to the batch upload URL that you received from the CTRO.
The Batch Upload page appears. All fields are required.

Figure 3.37 Batch Trial Upload Page
2. In the Organization Name field, type the name of the organization associated
with the trials you want to register.
3. Beside the Trial Data field, click Browse and navigate to the .xls file that
contains all the trial data. See Data Requirements for Batch Uploads on
page 68.
4. Beside the Documents Zip field, click Browse and navigate to the .zip file
that contains all the trial-related documents.
5. Click Upload Trial.
The batch upload program generates a report after processing the batch data
and emails it to the submitter. The report includes a brief summary and the
detailed status of each trial.
Related topics:


Data Requirements for Batch Uploads on page 68



Using the Batch Upload Template on page 12

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Batch Upload Data Specifications on page 87



Data Requirements for Batch Uploads
Elements that are required for single trial registration are also required for batch
uploads, with the exception of person/organization attributes. The complete set of
person/organization attributes for registering new persons/organizations is required for
Principal Investigator, Lead Organization, Sponsor, and Summary 4 Sponsor/Source
trial functional roles.
In addition to the data elements listed above, you must provide certain other
information depending on the values you provided, as listed inTable 3.14
Detailed specifications are provided in Appendix A, Batch Upload Data Specifications,
on page 87.
If you provide this value...

You must also provide/select this

Primary purpose of a trial = “Other”

A comment that describes the purpose of the
trial.

Study type = “Interventional”

Summary 4 Source Category information

- and Lead organization of participating
organization type = “cancer center”
If lead organization or participating
organization type = “cancer center”

Summary 4 Source Category information

Any value for one of the following:

Values for the rest of those listed as well



Funding Mechanism



NIH Institution Code



Serial Number



NCI Division/Program

Any value for Grant Serial Number

A grant serial number that is 5 or 6 digits long

Any value for one of the following IND/IDE
elements:

Values for the rest of those listed as well



Type



Serial number



Grantor



Holder type

(IND/IDE) Grantor Type = “IND”

CDER or CBER

(IND/IDE) Grantor Type = “IDE”

CDRH

(IND/IDE) Holder Type ID = “NIH”

NIH Institution code

(IND/IDE) Holder Type ID = “NCI”

NCI Division/Program code

Has Expanded Access = “Yes”

Expanded Access Status code

Trial Start Date Type = “Actual”

A date that is current or past

Trial Start Date Type = “Anticipated”

A date that is in the future

Table 3.14 Data element requirements based on selected values
68

Chapter 3 Registering New Trials

If you provide this value...

You must also provide/select this

Primary Completion Date Type = “Actual”

A date that is current or past

Primary Completion Date Type = “Anticipated”

A date in the future

If Current Trial Status = “Active”

Trial Start Date must be the same as, or
precede, the Current Trial Status Date
Trial Start Date type = “Actual”

If Current Trial Status = “Active”
- and -

The actual Start Date in place of the Current
Trial Status Date

Actual Trial Start Date precedes Current Trial
Status Date
If Current Trial Status = “Active”

A Trial Start Date that is the same as Current
Trial Status Date, where type = “Actual”

If Current Trial Status = “Approved”

Trial Start Date type = “Anticipated”

- or If Current Trial Status = “In Review”
Current Trial Status =/ “Approved”

Trial Start Date type = “Actual”

- or If Current Trial Status =/ “In Review”
Current Trial Status = “Completed”

A Primary Completion Date that is the same
as Current Trial Status Date, where type =
“Actual”

Current Trial Status = “Completed”

A Primary Completion Date type that is
“Actual”

- or Current Trial Status = “Administratively
Completed”
Current Trial Status =/ “Completed”
- or -

A Primary Completion Date type that is
“Anticipated”

Current Trial Status =/ “Administratively
Completed”
Trial Start Date

A Primary Completion Date that is the same
value or greater

Table 3.14 Data element requirements based on selected values
Related topics:


Using the Batch Upload Template on page 12



Batch Upload Data Specifications on page 87

NCI CTRP Trial Registration Site v.3.1 User’s Guide

C HA PTE R

UPDATING AND AMENDING REGISTERED
TRIALS
This chapter describes how to update and make amendments to non-proprietary trials
currently registered and verified in the CTRP.
This chapter includes the following topics:


About Trial Updates



Updating Accepted Trials



About Trial Amendments



Amending Verified Trials



Reviewing and Submitting Trial Amendments and Updates

About Trial Updates
The CTRP Registration Site enables you, in the role of trial owner (submitter or new
trial owner), to update trials that you yourself have registered with the CTRP previously.
You can update only those trials that have been previously accepted (i.e., the
processing status must be Accepted.)
Note: You can not update a study that has been Disapproved, Withdrawn, Completed, or
Administratively Completed.
Use the Update Trial feature when changes to the trial are not a consequence of
changes to the protocol document. Use the Amend Trial feature when changes to the
trial involve changes to the protocol document that require IRB approval.
Note: You can update/amend non‐proprietary trials only in CTRP Registration Site versions
3.0 and 3.1.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Tip:

You can also update trials in batches. See Preparing the Trial Data File for Non‐Proprietary
Trials on page 87.
Related topics:


Updating Accepted Trials on page 72



About Trial Amendments on page 74



Amending Verified Trials on page 76



Reviewing and Submitting Trial Amendments and Updates on page 81

Updating Accepted Trials
You can update most information included with the original trial submission, including
the following:


Trial details



Responsible Party/Sponsor personal contact and generic contact information



Summary 4 information



NIH Grant information



Update existing grant information

Add new unique grant (do not submit duplicates)

IND/IDE information
o

Add new unique IND/IDE (do not submit duplicates)



Regulatory information



Participating sites
o

Site recruitment status and associated date and site program code for
abstracted trail sites.



Collaborator’s functional role



Regulatory information (new IRB approval documents)

Note: The system sends you, the trial owner, an update notification whenever you update
accepted trials.
How to Update Trials
1. On the navigation pane on the left side of the page, click Search Trials.
The Search Trials page appears (Figure 4.1).

Chapter 4 Updating and Amending Registered Trials

Figure 4.1 Search Trials Page
Tip:

If you know the NCI trial number of your verified trial that you want to
amend, in the Identifier Type field, select NCI, and then type the trial
number in the Identifier field.

2. Click Search My Trials.
The Search Trials page refreshes and displays a list of search results
(Figure 4.2).

Figure 4.2 “Search My Trials” Result List
For information about navigating the search results list, see Navigating Through
the Search Results List on page 20.
3. Locate the trial you want to update, and then click the Update link in the
corresponding column.
The Update Trial page displays the data currently registered with the CTRP
(Figure 4.3).

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Figure 4.3 Update Trial Page – Trial Details and Sponsor/Responsible Party Sections
4. Make changes to the fields as necessary. Instructions for providing/editing trial
details are provided in Registering Non-Proprietary Trials in the CTRP
Registration Site on page 27.
5. If appropriate, upload the documents for IRB approval.
6. 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.
7. If necessary, correct any errors, and click Review Trial. Repeat this cycle until
your update is error-free.
8. Submit the trial update.
Related topics:


About Trial Updates on page 71



About Trial Amendments on page 74



Amending Verified Trials on page 76



Reviewing and Submitting Trial Amendments and Updates on page 81

About Trial Amendments
The CTRP Registration Site enables you, in the role of trial owner, to amend nonproprietary verified trials that you yourself have registered with the CTRP previously.
The CTRO reviews and abstracts amended trial data just as it does with original
submissions.

Chapter 4 Updating and Amending Registered Trials

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 CTRP Registration
Site features prior to submission.
Note: You can also amend trials in batches. See Preparing the Trial Data File for Non‐Proprietary
Trials on page 87.
Related topics:


Amendment Process Life Cycle on page 75



Amending Verified Trials on page 76



Uploading Amendment-Specific Documents on page 80



Reviewing and Submitting Trial Amendments and Updates on page 81

Amendment Process Life Cycle
The CTRP processes submissions in much the same way as it processes original trial
data. 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—in 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. If rejected, the system
provides the reason for rejection and reinstates your latest verified trial.
3. If your amendment is accepted, the CTRO abstracts all the trial details and
sends you a Trial Summary Report (TSR) and XML document that include 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 resend s the TSR and XML documents.
6. The amended trial appears in your Search My Trials results list upon
acceptance.
Note: The TSR contains all the information that you submitted and all the trial data
abstracted by the CTRO. The XML version of the TSR is formatted to facilitate trial
registration with ClinicalTrials.gov.
Related topics:


Amending Verified Trials on page 76



Uploading Amendment-Specific Documents on page 80

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Reviewing and Submitting Trial Amendments and Updates on page 81

Amending Verified Trials
In your role as trial owner (original submitter or current owner), you can amend only
non-proprietary trials. The trials you own are listed when you use the Search My Trials
feature. See Transferring Trial Ownership on page 85 and Searching For Trials on
page 16.
Note: You are required to provide information for all fields marked with an asterisk (*).
How to Amend Verified Trials
1. On the navigation pane on the left side of the page, click Search Trials.
The Search Trials page appears (Figure 4.1).

Figure 4.4 Search Trials Page
Tip:

If you know the NCI trial number of your verified trial that you want to
amend, in the Identifier Type field, select NCI, and then type the trial
number in the Identifier field.

2. Click Search My Trials.
The Search Trials page refreshes and displays a list of search results
(Figure 4.2).

Figure 4.5 “Search My Trials” Result List

Chapter 4 Updating and Amending Registered Trials

For information about navigating the search results list, see Navigating Through
the Search Results List on page 20.
3. Locate the trial you want to amend, and then click Amend in the corresponding
Action column.
The Amendment Trial page displays the data currently registered with the
CTRP (Figure 4.3).

Figure 4.6 Amendment Trial Page – Amendment and Trial Details
4. In the Amendment Number field, type the number as recorded in the system
(as designated by the leas organization) or in the amended protocol document.
Note: Type the Amendment Number in alpha‐numeric characters, dashes, and
other special characters as appropriate.
5. In the Amendment Date field, type the date on which the trial was amended
using the mm/dd/yyyy format, or, click the calendar icon ( ) and select the
date from the calendar.
6. Make changes in the rest of the fields as per the amended protocol.
7. Upload the amendment-specific documents.
8. Review the amendment.
9. Submit the amended trial to the CTRP.
Instructions for providing/editing most of the trial amendment details are provided in
Registering Non-Proprietary Trials in the CTRP Registration Site on page 27.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Amendment-specific rules, values, etc., are provided for each section of the
Amendment Trial page as follows:
Related topics:


Amending Verified Trials on page 76



Amending Lead Organization and Principal Investigator Details on page 78



Amending Sponsor and Summary 4 Details on page 79



Amending NIH Grant Details on page 79



Amending Trial Status Dates on page 79



Amending IND/IDE Details on page 80



Uploading Amendment-Specific Documents on page 80

Amending Trial Details
Instructions and values for completing the trial details section are the same for both
original and amended submissions. See Completing the Trial Details Section on
page 31.
Note: You cannot change an NCI trial identifier number.
Related topics:


Amending Verified Trials on page 76



Amending Lead Organization and Principal Investigator Details on page 78



Amending Sponsor and Summary 4 Details on page 79



Amending NIH Grant Details on page 79



Amending Trial Status Dates on page 79



Amending IND/IDE Details on page 80



Uploading Amendment-Specific Documents on page 80

Amending Lead Organization and Principal Investigator Details
Instructions for completing the lead organization and principal investigator section are
the same for both original and amended submissions. See Completing the Lead
Organization/Principal Investigator Section on page 34.
Tip:

If the person taking on the role of PI is not registered in the CTRP system, you can
“create” a new person record at this time. The record will remain pending until the
CTRO curator can confirm the new person’s details however. The same process applies
to new lead organizations.
Related topics:


Amending Verified Trials on page 76

Chapter 4 Updating and Amending Registered Trials



Amending Trial Details on page 78



Amending Sponsor and Summary 4 Details on page 79

Amending Sponsor and Summary 4 Details
Instructions for completing the Summary 4 section are the same for both original and
amended submissions. See Completing the Summary 4 Information Section on
page 38.
Tip:

If the person taking on the role of sponsor is not registered in the CTRP system, you
can “create” a new person record at this time. The record will remain pending until the
CTRO curator can confirm the new person’s details however.
Related topics:


Amending Verified Trials on page 76



Amending Lead Organization and Principal Investigator Details on page 78



Amending Verified Trials on page 76



Amending Lead Organization and Principal Investigator Details on page 78

Amending NIH Grant Details
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

Instructions for completing the NIH grant section are the same for both original and
amended submissions. See Completing the NIH Grant Information Section on page 39.
Note: You cannot change an existing NIH grant number.
Related topics:


Amending Verified Trials on page 76



Amending Sponsor and Summary 4 Details on page 79



Amending IND/IDE Details on page 80

Amending Trial Status Dates
You must complete all fields in the Status/Dates section. Valid dates for a given trial
status depend on the other values you have entered, and whether those dates are
actual or anticipated. Follow the rules for trial status dates provided in Table 3.7 on
page 44.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Instructions for completing the Trial Status Dates section are the same for both original
and amended submissions. See Completing the Trial Status/Dates Section on page 44.
Related topics:


Amending Verified Trials on page 76



Reviewing and Submitting Trial Amendments and Updates on page 81

Amending IND/IDE Details
Instructions for completing the IND/IDE section are the same for both original and
amended submissions. See Completing the IND/IDE Information Section on page 46.
Note: You cannot change an existing IND/IDE serial number.
Related topics:


Amending Verified Trials on page 76



Amending Sponsor and Summary 4 Details on page 79



Amending NIH Grant Details on page 79

Uploading Amendment‐Specific Documents
The following amendment-specific documents are required with submission:


Change memo document – Contains a summary of changes to the original, or
last amended, trial submission



Amended protocol (or Proprietary Protocol document)



IRB approval for the amended protocol



Participating sites document – Required if there have been changes to the
following:
o

Participating sites/investigators

Contact information

Trial status

Informed Consent – Required if you have a new informed Consent document
that is not attached to the amendment protocol

The CTRP Registration Site accepts documents in the following formats:


PDF



MS Word



MS Excel



Corel Word Perfect

Instructions for completing the IND/IDE section are the same for both original and
amended submissions. However, additional fields are provided specifically for the

Chapter 4 Updating and Amending Registered Trials

amendment-related documents. See Completing the Trial Related Documents Section
on page 51.
Note: You cannot update or delete existing documents.
Related topics:


Amending Verified Trials on page 76



Amending Trial Details on page 78



Amending Trial Status Dates on page 79

Reviewing and Submitting Trial Amendments and Updates
After you have completed amending or updating the trial information, review the
information for errors and edit any details that do not match the changes in your change
memo, amended protocol document, or other source. You can print a copy of the
Amendment Trial and Update Trial pages to facilitate the review and/or keep for your
records.
How to Review and Submit Trial Amendments and Updates
1. Complete all modifications to the most recent trial submission.
2. Scroll to the bottom of the Amendment Trial/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 amendment/update is error-free.
Note: The Review Trial Details page is read‐only. To edit information that you
have reviewed, see Editing Amended and Updated Details on page 81
4. Click Submit.
Related topics:


Amending Verified Trials on page 76



Editing Amended and Updated Details on page 81



Printing Amended and Updated Trial Information on page 82

Editing Amended and Updated Details
You can edit your amended/updated trial details after you have reviewed them at any
time before you submit them to the CTRP.
How to Edit Amended and Updated Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit.

NCI CTRP Trial Registration Site v.3.1 User’s Guide

The Amendment Trial/Update Trial page displays all information you have
provided in editable form.
Caution: You must upload the amendment‐ or update‐related trial documents
again each time you click the Edit button.
2. Make changes as necessary and then follow the instructions in Reviewing and
Submitting Trial Amendments and Updates on page 81.
Related topics:


Amending Verified Trials on page 76



Reviewing and Submitting Trial Amendments and Updates on page 81



Printing Amended and Updated Trial Information on page 82

Printing Amended and Updated Trial Information
You can print a copy of the amended/updated 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 and Updates on page 81.
How to Print Amended and Updated Trial Information
1. Review the amended trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.
Related topics:



Amending Verified Trials on page 76



Reviewing and Submitting Trial Amendments and Updates on page 81



Editing Amended and Updated Details on page 81

C HA PTE R

MANAGING YOUR ACCOUNT
This chapter provides instructions for modifying your CTRP Registration Site account,
resetting your password, and transferring trial ownership.
This chapter includes the following topics:


Managing Your User Account Profile



Managing Your Password



Transferring Trial Ownership

Managing Your User Account Profile
You can update account information after you register as a user.
How to Edit Your Account Information
1. Do one of the following to access the My Account page:
o

On the right side of the title bar at the top of the page, click your Username
link

- or o

On the navigation pane on the left side of the page, click My Account.

The My Account page appears, populated with the information you previously
supplied for your account.
2. In the Your Account Profile section, complete the remainder of the fields
requesting personal information. Fields with an asterisk (*) are required.
3. Click Submit Account Updates to save changes to the account information.
Related topics:


Creating an Account on page 6

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Logging In to the CTRP Registration Site on page 8



Managing Your Password on page 84



Transferring Trial Ownership on page 85

Managing Your Password
You can change your CTRP Registration Site password at any time when logged in.
And, should you forget your password, you can reset it. For instructions, see Changing
Your Password on page 84 and Resetting Your Password on page 84.
Related topics:


Creating an Account on page 6



Logging In to the CTRP Registration Site on page 8



Changing Your Password on page 84



Resetting Your Password on page 84

Changing Your Password
You can change your CTRP Registration Site password only once you have logged in
to the application.
How to Change Your Password
1. Do one of the following to access the User Account page:
o

On the right side of the title bar at the top of the page, click your Username
link

- or o

On the navigation pane on the left side of the page, click My Account.

The My Account page appears, populated with the information you previously
supplied for your account.
2. In the Login Information section, type a new password in the Password field.
3. In the Re-type Password field, retype the password to confirm it.
4. Click Submit Account Updates to save your changes.
Related topics:


Creating an Account on page 6



Logging In to the CTRP Registration Site on page 8



Resetting Your Password on page 84

Resetting Your Password
In the event that you can not remember your password, you can request a password
reset.

Chapter 5 Managing Your Account

How to Reset Your Password
1. On the navigation pane on the left side of the page, click Log In.
2. On the Login page, click the Forgot Your Password link, and continue with
Step 3 in Creating an Account on page 6.
Related topics:


Creating an Account on page 6



Logging In to the CTRP Registration Site on page 8



Changing Your Password on page 84

Transferring Trial Ownership
CTRP Registration Site account holders can submit new clinical trial protocol details.
The trial submitter is designated trial owner upon registration. Only the trial owner can
amend or update the verified trial. As a current trial owner, you can transfer ownership
of your trial to a designee. Once transferred, the new owner can update and amend the
trial.
How to Transfer Trial Ownership
1. Ask your prospective trial owner to register for an account in the CTRP
Registration Site.
2. Submit a request for change of trial ownership to the CTRO via email at
mailto:[email protected]. Include the following information with
your request:
o

NCI ID of the trial for which you want to transfer ownership

Prospective trial owner’s first name, last name, and email address as
recorded in the account profile.

The CTRO notifies you when they have completed the trial ownership transfer.
Related topics:


Creating an Account on page 6



Managing Your User Account Profile on page 83



Updating and Amending Registered Trials on page 71

NCI CTRP Trial Registration Site v.3.1 User’s Guide

A PPENDIX

BATCH UPLOAD DATA SPECIFICATIONS
This chapter describes how to prepare trial data and trial documents when registering
multiple trials in a batch. It also provides data specifications for the trial data.
This chapter includes the following topics:


Preparing the Trial Data File for Non-Proprietary Trials



Preparing Trial-Related Documents



Trial Data Element Specifications For Non-Proprietary Trials



Preparing the Trial Data File for Proprietary Trials



Trial Specification Rules For Proprietary Trials

Preparing the Trial Data File for Non‐Proprietary Trials
The CTRP website provides a batch upload template, valid data values, data
definitions, examples, and rules for registering batches of trials and trial amendments/
updates. This section contains a summary of the information required for the .xls file.
See Using the Batch Upload Template on page 12.
The .xls file that contains the trial data you want to register via the CTRP
Registration Site’s batch upload feature, and the trial-related documents associated
with it, must meet certain specifications for successful registration.
You must provide trial data in the Microsoft Excel format, .xls. This version of the
batch upload feature supports the following data elements:


Multiple grants per trial



Multiple IND/IDEs per trial



100 trials per file



Interventional trials only

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Non-proprietary trials only

How to Prepare the Trial Data File


In Microsoft Excel, list the trial elements required for registration in the order
specified in the CTRP_Registry_Batch_Upload.xls file.

Related topics:


Preparing Trial-Related Documents on page 88



Trial Data Element Specifications For Non-Proprietary Trials on page 89



Preparing the Trial Data File for Proprietary Trials on page 90



Trial Specification Rules For Proprietary Trials on page 90

Preparing Trial‐Related Documents
You must ensure that all trial-related document file names are unique. Depending on
your own method of storing documents, you may have to rename your files.
For example:
Your directory structure is set up so that each trial has its own folder, and you name
each document file by its topic, as illustrated in Figure A.1 below.

Figure A.1 Example Directory Structure for Trial‐Related Documents
Without the directory structure, there is no way to tell which trial a document belongs to.
Because there is no indication of directory structure in the batch upload file, you need
to rename each file to associate it with a given trial and to prevent one file from
overwriting another document that shares the same file name.

Appendix A Batch Upload Data Specifications

The best way to rename the files is to add the unique trial identifier as a prefix to each
of the file names, as follows:


NCI-2009-12345_protocol.doc



NCI-2009-12345_irb_approval.doc



NCI-2009-12345_informed_consent.doc



NCI-2009-12346_protocol.doc



NCI-2009-12346_irb_approval.doc



NCI-2009-12346_informed_consent.doc



NCI-2009-12347_protocol.doc



NCI-2009-12347_irb_approval.doc



NCI-2009-12347_informed_consent.doc

How to Prepare the Trial-Related Documents
1. If appropriate, identify each of the documents associated with a given trial by
adding the trial’s unique trial identifier as a prefix to the beginning of their file
names.
Note: Accepted document file types include PDF, WORD, XLS, and Word
Perfect.
2. Ensure that no two documents for the same trial share the same file name.
3. List the trial-related document file names for each trial in the trial data file (.xls
file). You can list up to 5 files per trial record.
4. Zip all the trial documents. Do not include path names in the .zip file.
Related topics:


Preparing the Trial Data File for Non-Proprietary Trials on page 87



Trial Data Element Specifications For Non-Proprietary Trials on page 89



Preparing the Trial Data File for Proprietary Trials on page 90



Trial Specification Rules For Proprietary Trials on page 90

Trial Data Element Specifications For Non‐Proprietary Trials
The CTRP_Registry_Batch_Upload.xls file lists all trial data required for
registering multiple trials in batches. Trial data specifications include the following:


Order in which the data must appear in an .xls file



Trial data elements for which you provide the trial protocol details



Designation of data element as being required or not



Valid data values

NCI CTRP Trial Registration Site v.3.1 User’s Guide



Comments

To access the CTRP_Registry_Batch_Upload.xls file, see Downloading Trial
Registration Templates on page 10.
For further details about trial data, refer to Metadata Definitions on page 95.
Related topics:


Preparing the Trial Data File for Non-Proprietary Trials on page 87



Preparing Trial-Related Documents on page 88



Preparing the Trial Data File for Proprietary Trials on page 90



Trial Specification Rules For Proprietary Trials on page 90

Preparing the Trial Data File for Proprietary Trials
The CTRP website provides a batch upload template, valid data values, data
definitions, examples, and rules for registering batches of proprietary trials. This section
contains a summary of the information required for the .xls document. See Using the
Proprietary Trial Template on page 11.
How to Prepare the Trial Data File
1. In Microsoft Excel, list the trial elements required for registration in the order
specified in the Registry_Proprietary_Trial_Template.xls file.
2. Email the file to CTRO at mailto:[email protected] as an
attachment.
CTRO staff process your file and register your trials.
Note: Because the CTRO staff submit your trials, they maintain trial ownership by default.
To assume ownership of the trials, send a request for trial ownership to the CTRO
along with the .xls file. For detailed instructions, see Transferring Trial Ownership on
page 85.
Related topics:


Preparing the Trial Data File for Non-Proprietary Trials on page 87



Preparing Trial-Related Documents on page 88



Trial Data Element Specifications For Non-Proprietary Trials on page 89



Trial Specification Rules For Proprietary Trials on page 90

Trial Specification Rules For Proprietary Trials
The Registry_Proprietary_Trial_Template.xls file lists all trial data required
for registering multiple trials in batches.
Rules for submitting specified data include the following:

Appendix A Batch Upload Data Specifications



Maintain the order in which the data appear in the .xls file



Uniquely identify each trial



If you provide an NCT trial number, you do not have to provide the following
data:
o

primary purpose

phase

disease

intervention

If the CTRO identifies a trial as a duplicate to an existing trial, you can request that they
add your organization information to the existing trial as a participating site instead of
creating a duplicate.To access the
Registry_Proprietary_Trial_Template.xls, see Downloading Trial
Registration Templates on page 10.
Related topics:


Preparing the Trial Data File for Non-Proprietary Trials on page 87



Preparing Trial-Related Documents on page 88



Trial Data Element Specifications For Non-Proprietary Trials on page 89



Preparing the Trial Data File for Proprietary Trials on page 90



Transferring Trial Ownership on page 85

NCI CTRP Trial Registration Site v.3.1 User’s Guide

A PPENDIX

PARTICIPATING SITES
DOCUMENT SPECIFICATIONS
This chapter provides the specifications—rules, formats, requirements, etc.—for
Participating Sites documents.
This chapter includes the following topics:


Participating Sites Document Rules



Participating Site Data Element Specifications

Participating Sites Document Rules
Participating site documents include treating site and collaborator information. They are
applicable to non-proprietary trials only.
The CTRP website provides participating site document templates, valid data
elements, and rules. See Using the Participating Sites Template on page 11.This
section contains a summary of the participating sites document rules.
Note: Collaborator information is optional.
The following rules apply to participating site documents:




Treating site information must include the following:
o

study treating site data

at least one study site investigator's information

treating site or study contact information

Treating site data includes the following:
o

organization attribute

NCI CTRP Trial Registration Site v.3.1 User’s Guide



current recruitment status

status date

target program code

Target accrual information for a study at a treating site is optional if the following
are true:
o

the site is not a cancer center (as defined by the CTRP)

the lead organization is not a cancer center.

Study/site investigator information includes the following:
o

study site investigator data with person's attributes

investigator's role at the study at site

Study/site generic contact information includes the following:
o

generic contact's title

generic contact's email address and phone number

Treating site contact information is optional if an investigator is used as contact
person, or if study site contact information is provided.
The minimal set of treating site information includes the following:
o

treating site data

study site investigator's information and site or study contact information

For studies with multiple investigators, create one line per investigator/site using
the treating site number as reference.

Related topics:


Participating Site Data Element Specifications on page 94



Batch Upload Data Specifications on page 87

Participating Site Data Element Specifications
The CTRP_Participating_Sites_Template.xls file lists all trial data required for
for participating site documents, including collaborating site information. To access the
template, see Downloading Trial Registration Templates on page 10.
Related topics:



Participating Sites Document Rules on page 93



Batch Upload Data Specifications on page 87

Appendix C Metadata Definitions

APPENDIX

METADATA DEFINITIONS
This appendix provides the values and definitions of the metadata associated with
clinical trials.

Allocation

Assignment of participants to an intervention group.
Allocation Values

Definitions

N/A

Single arm study

Randomized Controlled Trial

Participants are assigned to intervention groups by chance

Non-randomized Trial

Participants are expressly assigned to intervention groups
through a non-random method, such as physician choice

Table C.1 Allocation definitions and valid values

Amendment Number
Number assigned to the amended protocol by the lead organization. Can be the part of
the amended protocol document.

Current Trial Status Date

Date the trial status was assigned to the trial, using the format mm/dd/yyyy.
Example: 10/28/2008

Funding Mechanism
NCI code used to identify areas of extramural research activity applied to various
funding mechanisms.
Funding Mechanism Values

Definitions

B09

Mental Health Services Block Grant

D43

International Training Grants in Epidemiology

C06

Research Facilities Construction Grant

D71

International Training Program Planning Grant

DP1

NIH Director’s Pioneer Award (NDPA)

X02

Pre-application

DP2

NIH Director’s New Innovator Awards

Table C.2 Funding Mechanism definitions and valid values

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Identifier Type

Type of organization (system) that assigns the identifier to the trial (for example, Lead
Organization, or NCI CTRP)
Identifier Type Values

Definitions

NCI

National Cancer Institute

Lead Organization

Organization responsible for the overall scientific and administrative
coordination, study monitoring, and data management activities of a
particular clinical trial

Table C.3 Identifier Type definitions and valid values

Intervention Model

Design of an interventional study.
Intervention Model
Values

Definitions

Single Group

Single arm study

Parallel

Participants are assigned to one of two or more groups in parallel
for the duration of the study

Cross-over

Participants receive one of two alternative interventions during the
initial phase of the study and receive the other intervention during
the second phase of the study

Factorial

Two or more interventions, each alone and in combination, are
evaluated in parallel against a control group

Table C.4 Intervention Model definitions and valid values

Lead Organization

Organization responsible for the overall scientific and administrative coordination, study
monitoring, and data management activities of a particular clinical trial.
Example: NSABP-B-40

Lead Organization Trial Identifier (ID)

Unique identification assigned to the protocol by the lead 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.
Example: Merck-023

Note: Note: Inter‐Group trials use the lead Groups trial number.

Masking
Hiding knowledge of intervention assignment
Masking Values

Definitions

Open

No masking

Table C.5 Masking definitions and valid values (Continued)

Appendix C Metadata Definitions

Masking Values

Definitions

Double Blind

Two or more parties are unaware of the intervention assignment

Single Blind

One party, either the investigator or participant, is unaware of the
intervention assignment; also called single-masked study

Table C.5 Masking definitions and valid values (Continued)

Milestones

Stages in the trial processing life cycle. Record progress in trial processing and set the
trial processing status. Interrelated with on-hold states.
Milestone Values

Definitions

Submission Received Date

Date the trial was successfully submitted via the NCI
CTRP Registration Site

Ready for QC Date

Date the trial abstraction was completed so that
Quality Control (QC) of the abstraction could be
initiated

Submission Acceptance Date

Date the document specialist accepted the trial
submission for validation

QC Start Date

Date of initial QC of the abstraction

Ready for PDQ Abstraction Date

Date PDQ first had access to the trial record to
abstract selected subsets of trial attributes

QC Completed Date

Date that QC of the abstraction was completed

Submission Rejection Date

Date the document specialist rejected the trial
submission during validation

PDQ Abstraction Completed Date

Date that PDQ completed the abstraction of the
selected subset of trial attributes

Administrative Processing Start Date

Date of initial abstraction of administrative details

Trial Summary Report Sent Date

Date the Trial Summary Report was sent to the
principal investigator or trial submitter

Administrative Processing
Completed Date

Date the abstraction of administrative details was
completed

Submitter Trial Summary Report
Feedback Date

Date input was received by a document specialist
from a principal investigator or trial submitter
regarding data contained on the Trial Summary
Report

Scientific Processing Start Date

Date of initial abstraction of the scientific details

Initial Abstraction Verified Date

Date the document specialist recorded that the
abstracted data was verified upon receipt of the
submitter's TSR feedback
TSR feedback is due within 5 business days following
the TSR Sent Date.
The Initial Abstraction Verified Date can be later if no
feedback is received

Table C.6 Milestone definitions and valid values (Continued)

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Milestone Values

Definitions

Scientific Processing Completed
Date

Date the abstraction of scientific details was
completed

On-going Abstraction Verified Date

Date the document specialist recorded that
abstracted data was verified, following a post-verified
status when there has been an abstraction update or
a delay in the submitter's feedback

Table C.6 Milestone definitions and valid values (Continued)

NCI Division/Program Code

Codes that represent individual NCI divisions and programs.
NCI Division/Program
Code Values

Definitions

CCR

Center for Cancer Research

Office of the Director, NCI, NIH

CTEP

Cancer Therapy Evaluation Program

OSB/SPOREs

Organ Systems Branch (OSB)/Specialized Programs of
Research Excellence (SPOREs)

DCB

Division of Cancer Biology

CIP

Cancer Imaging Program

DCCPS

Division of Cancer Control and Population Sciences

CDP

Cancer Diagnosis Program

DCEG

Division of Cancer Epidemiology and Genetics

TRP

Translational Research

DTP

Developmental Therapeutics Program

RRP

Radiation Research Program

DCP

Division of Cancer Prevention

N/A

Not applicable

DEA

Division of Extramural Activities

Table C.7 NCI Division/Program Code definitions and valid values

NCI Trial Identifier

Unique identifier assigned to the trial by the NCI Clinical Trials Reporting Program Trial
Registration Site application.
Example: NCI-2010-ABCD

NIH Grant Information

NIH grant code. A concatenation of a number of elements.

Appendix C Metadata Definitions

Note: The Grant Identification Number is also commonly referred to as Assignment Number,
Application Number, or the Award Identification Number, depending upon its
processing status.
Example: 1 R01 CA 009999 - 08 A1 S2

Note: There are no spaces in the grant code; they have been inserted in this
example for clarification purposes only.
where,
1 is the single-digit code identifying the type of application received and processed
R01 is the three-digit code identifying a specific category of extramural activity
CA is the two-letter code identifying the assignment or funding NIH Institute or Center
009999 is the six-digit number generally assigned sequentially to a series within an Institute,
Center, or Division
- separates the serial number from the grant year
08 is the two-digit number indicating the actual segment or budget period of a project The grant
year is preceded by a dash to separate it from the serial number.
A1 is the letter code for a resubmitted application, (commonly referred to as an Amendment)
and related number that identifies a particular amendment record
S2 is the letter code for Revision (for Supplemental funding) and related number identifying a
particular supplemental record.

NIH Institute Code (NIH Grant Code)
NIH code used to identify the first major-level subdivision—the NIH organization that
supports a grant. The support may be financial or administrative.
Institute
Code
Values

Definitions

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute on Aging (NIA)

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

NIAID Research Support

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

National Center for Complementary and Alternative Medicine (NCCAM)

Division of Basic Sciences (NCI)

National Cancer Institute (NCI)

Division of Cancer Biology and Diagnosis (NCI)

Clinical Center (CLC)

Division of Cancer Treatment (NCI)

Division of Cancer Prevention and Control (NCI)

Office of the Director (NCI)

Table C.8 NIH Institute Codes

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Institute
Code
Values

Definitions

Division of Cancer Epidemiology and Genetics (NCI)

Center for Information Technology (CIT)

National Institute on Drug Abuse (NIDA)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

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

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Environmental Health Sciences (NIEHS)

National Eye Institute (NEI)

National Institute of General Medical Sciences (NIGMS)

Genome Association Studies (GAS)

Division of Blood Diseases and Resources (NHLBI)

Division of Epidemiology & Clinical Applications (NHLBI)

National Institute of Child Health & Human Development (NICHD)

National Human Genome Research Institute (NHGRI)

Division of Intramural Research (NHLBI)

National Heart, Lung, and Blood Institute (NHLBI)

Office of the Director (NHLBI)

Division of Lung Diseases (NHLBI)

Division of Heart and Vascular Diseases (NHLBI)

Joint Funding

National Library of Medicine (NLM)

National Center on Minority Health and Health Disparities (NCMHD)

National Institute of Mental Health (NIMH)

Neuroscience Blueprint (NB)

National Institute of Nursing Research (NINR)

National Institute of Neurological Disorders and Stroke (NINDS)

Office of the Director (NIH)

Office of Research Facilities Development and Operations (ORFDO)

Office of Logistics and Acquisition Operations (OLAO)

Office of Research Services (ORS)

Division of Cancer Control and Population Science (NCI)

Division of Clinical Sciences (NCI)

Table C.8 NIH Institute Codes

100

Appendix C Metadata Definitions

Institute
Code
Values

Definitions

Superfund Basic Research Program (SBRP)

Women's Health Initiative (WHI, OD)

Center for Cancer Research (CCR)

Center for Scientific Review (CSR)

NIH Roadmap Initiative, Office of the Director (RMOD)

National Center for Research Resources (NCRR)

Fogarty International Center (FIC)

Worker Education Training Program (WETP)

Table C.8 NIH Institute Codes

Non‐proprietary Trial
Trial with no contractual restrictions for sharing the protocol document.

Primary Purpose

Reason for the protocol.
Primary Purpose Values

Definitions

Epidemiologic

Observational

Treatment

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

Outcome

Prevention

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

Table C.9 Primary Purpose definitions and valid values

101

NCI CTRP Trial Registration Site v.3.1 User’s Guide

Primary Purpose Values

Definitions

Ancillary

Early Detection

Correlative

Diagnostic

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

Health Services Research

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

Basic Science

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

Screening

Protocol 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)

Supportive Care

Other

Any trial type not defined here

Table C.9 Primary Purpose definitions and valid values

Principal Investigator

Investigator responsible for all aspects of the conduct of the study.
Example: Moitessier, Bernard

Processing Status
Current progress of the trial with respect to the abstraction process.
Processing Status Values

Definitions

All

Any status

Abstracted

Trial has been abstracted and is available for further
abstraction

Table C.10 Processing Status definitions and valid values

102

Appendix C Metadata Definitions

Processing Status Values

Definitions

Submitted

Original trial has been submitted but the abstraction
process has not begun

Amendment Submitted

Amendment has been submitted but the abstraction
process has not begun.

Verification Pending

TSR has been sent to the submitter, and the submitter's
feedback is pending

Abstraction Verified Response

Trial has been abstracted and completed, and the trial
submitter has responded to the TSR sent for verification

Accepted

Validated trial. A submitted trial that has passed
validation (conforms to the CTRO rules for valid
submission).

Rejected

Trial has been found invalid and is no longer available for
abstraction

Abstraction Verified No Response

Trial has been abstracted and completed, but the trial
submitter has not responded to the TSR sent for
verification

Table C.10 Processing Status definitions and valid values

Proprietary Trial

Trial with a contractual obligation that restricts sharing of the protocol document.

Responsible Party

As defined in US Public Law 110-85, Title VIII, Section 801, the term “responsible
party”, with respect to a clinical trial, can refer to either of the following:


Sponsor of the clinical trial
- or -



Example: Moitessier, Bernard
For further information about the definition of “responsible party”, see http://
prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.

Sponsor

Name of primary organization that oversees implementation of study and is responsible
for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3. For
further elaboration on the definition of Sponsor with respect to responsible party, see:
http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.
Example: Bristol-Myers Squibb

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Study Classification

Type of primary outcome or endpoint that the protocol is designed to evaluate.
Study Classification Values

Definitions

Safety

Indication that an intervention is safe under conditions of
proposed use

Bio-availability

Rate and extent to which a drug is absorbed or otherwise
available to the treatment site in the body

Efficacy

The maximum ability of a drug or treatment to produce a
result regardless of dosage. A drug passes efficacy trials if it
is effective at the dose tested and against the illness for which
it is prescribed. In a procedure mandated by the FDA, Phase
II clinical trials gauge efficacy, and Phase III trials confirm it.

Pharmacokinetics

The action of a drug in the body over a period of time
including the process of absorption distribution and
localization in tissue, biotransformation, and excretion of the
compound

Safety/Efficacy

Combined study of safety and efficacy

Pharmacodynamics

Action of drugs in living systems

Bio-equivalence

Scientific basis for comparing generic and brand name drugs

Pharmacokinetics/dynamics

Combined study of pharmacokinetics and pharmicodynamics

Table C.11 Study Classification definitions and valid values

Summary 4 Funding Category

Type of external sponsor or funding source based on the role/responsibility/
participation in the study. Based on authorship, drug supplement, trial monitoring
design, and implementation.
Summary 4 Funding
Category Values

Definitions

National

National Cooperative Group trials

Institutional

In-house, internally reviewed trials, including those collaborative
studies conducted with industry sponsorship in which the center
is a primary contributor to the design, implementation, and
monitoring of the trial, or participation in a multi-site trial initiated
by an investigator at another center

Externally Peer-Reviewed

R01s and P01s or other trial mechanisms funded by NIH or
supported by other peer-reviewed funding organizations

Industrial

Design and implementation of the study is controlled by the
pharmaceutical company

Table C.12 Summary 4 Funding Category definitions and valid values

Summary 4 Sponsor/Source

Primary organization responsible for funding the trial. It pertains to clinical trials
involving an agent or device, or other intervention only:
Example: CTEP

104

Appendix C Metadata Definitions

Title

Official name of the protocol provided by the study principal investigator or sponsor.
Example: A Pilot Study of Chemotherapy Plus Radiotherapy for Selected Stage IIIB
(No Malignant Effusion) Non-Small Cell Lung Cancer

Trial Phase

Code for a clinical trial that represents a distinguishable part or stage in a series of
events or in a process of development. Clinical trials are broken into three or four
phases.
Trial Phase Values

Definitions

Phase 0

Tests a new treatment that is available only in very limited quantities
and which has never previously given to humans or for which there is
extremely limited human experience to enable researchers to
understand the path of the drug in the body and its efficacy

Phase III

A study to compare the results of people taking a new treatment with
the results of people taking the standard treatment (for example, which
group has better survival rates or fewer side effects). In most cases,
studies move into phase III only after a treatment seems to work in
phases I and II. Phase III trials may include hundreds of people.

Phase I

The first step in testing a new treatment in humans. These studies test
the best way to administer a new treatment (e.g., by mouth,
intravenous infusion, or injection) and the best dose. The dose is
usually increased a little at a time in order to find the highest dose that
does not cause harmful side effects.
Because little is known about the possible risks and benefits of the
treatments being tested, phase I trials usually include only a small
number of patients who have not been helped by other treatments.

Phase IV

Evaluates the long-term safety and efficacy of a treatment for a given
indication and studies side effects that may have become apparent
after the phase III study was completed

Phase I/II

A clinical research protocol designed to study the safety, dosage levels
and response to new treatment. Phase I/II trials combine a Phase I and
a Phase II trial of the same treatment into a single protocol.

Pilot

Initial study examining a new method or treatment

Phase II

A study to test whether a new treatment has an anticancer effect (for
example, whether it shrinks a tumor or improves blood test results) and
whether it works against a certain type of cancer

N/A

Not applicable

Phase II/III

A trial to study response to a new treatment and the effectiveness of
the treatment compared with the standard treatment regimen

Other

Any phase not listed

Table C.13 Trial Phase definitions and valid values

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NCI CTRP Trial Registration Site v.3.1 User’s Guide

Trial Status

Code that represents the status of a trial in relation to the ability to enroll participants/
patients.
Trial Status Values

Definitions

Approved

Trial has been approved

In Review

Trial recruitment has not started

Temporarily Closed to
Accrual and Intervention

Trial is temporarily not accruing. Participants are not receiving
intervention

Active

Trial is open for accrual

Temporarily Closed to
Accrual

Trial is temporarily not accruing

Closed to Accrual

Trial has been closed to participant accrual. Participants are still
receiving treatment/intervention.l

Administratively
Complete

Trial has been completed prematurely (for example, due to poor
accrual, insufficient drug supply, IND closure, etc.)

Closed to Accrual and
Intervention

Trial has been closed to participant accrual. No participants are
receiving treatment/intervention, but participants are still being
followed according to the primary objectives of the study

Complete

The trial has been closed to accrual; participants have completed
treatment/intervention, and the study has met its primary
objectives

Table C.14 Trial Status definitions and valid values

Trial Type

Nature of the investigation. It represents a clinical study by product, procedure, or
method tested.

106

GLOSSARY
Acronyms, objects, tools and other terms referred to throughout this CTRP Registration
Site user’s guide are described in this glossary.
Term

Definition

accepted trial

Validated trial. A submitted trial that has passed validation (conforms to
the CTRO rules for valid submission).

accrual

The process of obtaining subjects for a study.

arm

Treatment group.

approved trial

Trial status indicator for a trial that has been approved by the review
board. Study activation preparation has begun.

basic science

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

caBIG

Cancer Biomedical Informatics Grid

caDSR

Cancer Data Standards Repository

CBER

Center for Biologics Evaluation and Research

CBIIT

Center for Biomedical Informatics and Information Technology (formerly
known as the National Cancer Institute Center for Bioinformatics or
NCICB)

CCB

Cancer Centers Branch

CCCT

Coordinating Center for Clinical Trials

CCR

Center for Cancer Research

CDE

Common Data Element

CDER

Center for Drug Evaluation and Research

CDP

Cancer Diagnosis Program

CGH

Comparative Genomic Hybridization

CIP

Cancer Imaging Program

CTAC

Clinical Trials Advisory Committee

CTEP

Cancer Therapy Evaluation Program

CTRO

Clinical Trials Reporting Office

CTRP

Clinical Trials Reporting Program

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108

Term

Definition

CTWG

Clinical Trials Working Group

compressed file

File that has been compacted to reduce file size

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

DCTD

Division of Cancer Treatment and Diagnosis

DEA

Division of Extramural Activities

DTP

Developmental Therapeutics Program

data monitoring
committee

Group of independent scientists who are appointed to monitor the safety
and scientific integrity of a human research intervention, and to make
recommendations to the sponsor regarding the stopping of the trial for
efficacy, for harm, or for futility.

delayed posting

Release of trial information on ClinicalTrials.gov is delayed until after an
interventional device has been approved or cleared.

disapproved trial

Trial status indicator for a trial that has been disapproved by the review
board upon submission and will not be re-submitted

EBI

European Bioinformatics Institute

EVS

Enterprise Vocabulary Services

FDA

Food and Drug Administration

IDE

Investigational Device Exemption. Allows the investigational device to
be used in a clinical study in order to collect safety and effectiveness
data required to support a Premarket Approval (PMA) application or a
Premarket Notification [510(k)] submission to FDA.

inclusion/exclusion
criteria

Medical or social standards determining whether a person may or may
not be allowed to enter a clinical trial. These criteria are based on such
factors as age, gender, the type and stage of a disease, previous
treatment history, and other medical conditions.

IND

Investigational New Drug. Authorization from the Food and Drug
Administration (FDA) to administer an investigational drug or biological
product to humans. Such authorization must be secured prior to
interstate shipment and administration of any new drug or biological
product that is not the subject of an approved New Drug Application or
Biologics/Product License Application.

IND Number

Investigational New Drug Number. Generally a 5-digit number (e.g.,
66,225) for non-biologic agents and a 4-digit number beginning with
“BB” for biologics (e.g., BB 1234) that the FDA assigns the
investigational agent being used in a specific clinical trial. It references
the drug(s) or product(s) used under a specific IND application.

IRB

Institutional Review Board

In review

Trial status indicator for a trial that has been submitted to the review
board for approval. Board approval is pending.

Glossary

Term

Definition

lead organization

Organization responsible for the overall scientific and administrative
coordination, study monitoring, and data management activities of a
given clinical trial.

MedDRA

Medical Dictionary for Regulatory Activities

N/A

Not applicable

NCI

National Cancer Institute

NCICB

National Cancer Institute Center for Bioinformatics (now known as the
Center for Biomedical Informatics and Information Technology or CBIIT)

NCT

National Clinical Trial

NCTID

National Clinical Trial Identifier (ClinicalTrials.gov identifier)

OCE

Office of Communications and Education

Office of the Director, NCI, NIH

OSB/SPOREs

Organ Systems Branch (OSB)/Specialized Programs of Research
Excellence (SPOREs)

P01

NIH grant activity code for Research Program Project

PDQ

Physician Data Query

Principal Investigator

PIO

Protocol Information Office

PRS

Protocol Registration System

private trial

Trial submitted by the user who is currently logged in to the CTRP
Registration Site

principal
investigator

Appointed investigator responsible for conducting clinical trial, or for
multi-site trials, the study chair

public trial

Trial submitted by a registered user other than the person currently
logging in to the CTRP Registration Site

Quality control

rejected trial

Trial did not pass validation (does not conform to the CTRO rules for
valid submissions.)

R01

NIH grant activity code for Research Project

RRP

Radiation Research Program

SPORE

Specialized Program of Research Excellence (Now TRP: Translational
Research Program)

sponsor

Name of primary organization that oversees implementation of study
and is responsible for data analysis. For applicable clinical trials,
sponsor is defined in 21 CFR 50.3. For further elaboration on the
definition of Sponsor with respect to responsible party, see: http://
prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.

TRP

Translational Research Program (Formerly SPORE)

trial status

The current stage or state of a clinical trial or study relative to other
stages.

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110

Term

Definition

trial type

Nature of the trial. Identifies a clinical study by product, procedure, or
method tested. The type of clinical trial performed, for example. efficacy,
safety.

TRP

Translational Research

TSR

Trial Summary Report

URI

Uniform Resource Identifier

URL

Uniform Resource Locators

validated trial

Trial who’s details—as entered by a submitter—have been confirmed
by a curator.

XML

Extensible Markup Language

Zip

File that contains one or more compressed files. Used as a verb when
using a compression tool to compress files.

INDEX
preparing, proprietary trials 90

A
accepted trial, defined 107
accounts

batch of trials
directory structure for 88
registering 66
required data elements for 87
rules for proprietary data 90
uploading 67

creating 6
managing 83
password management 84

accrual, defined 107
Administrative Processing Completed Date,
defined 97
Administrative Processing Start Date,
defined 97
allocation, defined 95
amending
IND/IDE information 80
lead organization information 78
NIH grant information 79
principal investigator information 78
Summary 4 information 79
trial details 78
trials 74, 76

amendments
editing 81
life cycle of 75
printing 82
reviewing 81

ancillary trial, defined 17, 102
application number, as grant identification
number 40
approved, defined 107
arm, defined 107
assignment number, as grant identification
number 40
award identification number, as grant
identification number 40

B
basic science, defined 102, 107
batch of files
ownership of 90
preparing 87

batch upload
directory structure for 88
preparing documents for 88
required data for 68
rules for 68
template for 12
trial data preparation 87
trial data preparation, proprietary trials 90

bio‐availability study, defined 104
bio‐equivalence study, defined 104
browsers, supported 5

C
caDSR, defined 107
CBER, defined 107
CBIIT, defined 107
CCB, defined 107
CCCT, defined 107
CCR, defined 107
CDE, defined 107
CDER, defined 107
CDP, defined 107
CGH, defined 107
CIP, defined 107
compressed file, defined 108
correlative trial, defined 17, 102
creating accounts 6
cross‐over intervention model, defined 96
CTAC, defined 107
CTEP, defined 107
CTRO, defined 107
CTRP_Participating_Sites_Template.xls,
downloading 10
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CTRP, defined 107
CTRP Registration Site
introduction to 5
supported browsers 5

CTRP templates and resources 10
CTWG, defined 108
current processing status, defined 21
current trial status
categories 45
defined 20

externally peer‐reviewed funding, defined 104

F
factorial intervention model, defined 96
FDA, defined 108
file formats for batch upload 89
funding mechanism, grant codes 41

G
grant 39
codes, funding mechanism 41
section, completing 39

D
data monitoring committee 108
data specification for non‐proprietary trials 89
DCB, defined 108
DCCPS, defined 108
DCEG, defined 108
DCP, defined 108
DCTD, defined 108
DEA, defined 108
delayed posting, defined 108
diagnostic trial, defined 102
directory structure for batch upload 88
disapproved, defined 108
division/program codes 42
documents
downloading 24
preparing, for batch upload 88
required 51
required, for batch uploads 67
section, completing 57
supported file formats 51, 57
supported file formats, batch upload 89
uploading, amendment‐specific 80
viewing 24

double blind masking, defined 97
downloading
CTRP registration templates 11
templates 10
trial‐related documents 24

DTP, defined 108

grantors 47

H
health services research trial, defined 102
holder types 48, 49

I
IDE
defined 108
section, completing 49

inclusion/exclusion criteria, defined 108
IND
section, completing 47

IND, defined 108
IND/IDE
grantors 47
section, amending 80
section, completing 46

IND number, defined 108
industrial funding category, defined 104
Initial Abstraction Verified Date, defined 97
In Review, defined 108
institute code, defined 99
institute codes 41
institutional funding category, defined 104
intervention model, defined 96
IRB, defined 108

E
early detection trial, defined 17, 102
EBI, defined 108
efficacy study, defined 104
eligibility criteria, defined 108
epidemiologic trial, defined 101
EVS, defined 108
expanded access 48
statuses of 48

expanded access trial, defined 17
112

lead organization
amending 78
defined 20, 96, 109
section, completing 34

lead organization trial identifier, defined 20
logging in 8
login
account management 83
password management 84

M
masking, defined 96
MedDRA, defined 109

N
N/A, defined 109
national funding category, defined 104
NCI, defined 109
NCICB
defined 109

NCI Trial Identifier, defined 20
NCT, defined 109
NCTID, defined 109
NIH
division/program codes 42
grant codes 41
grant details, amending 79
grant section, completing 39
institute codes 41

non‐proprietary trial
defined 101

non‐randomized trial allocation method,
defined 95

PDQ Abstraction Completed Date, defined 97
persons
adding 65
registering 62

pharmacodynamics study, defined 104
pharmacokinetics/dynamics study, defined 104
pharmacokinetics study, defined 104
phases
defined 105
trial 31

PI, defined 109
PIO, defined 109
prevention trial, defined 101
primary purpose
ancillary, defined 102
basic science 102
defined 101
epidemiologic, defined 101
health services research, defined 102
observational, defined 101
outcome, defined 101
prevention, defined 101
screening, defined 102
supportive care, defined 102
treatment, defined 101

principal investigator 102

O
observational trial, defined 18, 101
OCE, defined 109
OD, defined 109
On‐going Abstraction Verified Date, defined 98
open masking, defined 96
organizations
adding 61
registering 58
searching for 59

OSB/SPOREs, defined 109
outcome trial, defined 17, 101
ownership of trials, transferring 85

P
P01, defined 109
parallel intervention model, defined 96
participating site document
rules for 12, 93
specifications for 94

participating sites
document rules 93
template for 11

passwords
changing 84
requirements for 7
resetting 84

adding 65
amending 78
defined 21, 109
registering 62
registering new 65
searching for 63
section, completing 34

processing status
defined 102
definitions of 19

profile management 83
proprietary trial
batch upload specification 90
defined 103
documents required for 51
preparing for batch upload 90
registering 52
templates for 11

protocols
amending 76
specifications for batch uploads 89, 90
submitting 27, 52

PRS, defined 109
purpose
defined 101
valid values for 32

PDQ, defined 109
113

NCI CTRP Trial Registration Site v.3.1 User’s Guide

status/dates

QC, defined 109
QC Completed Date, defined 97
QC Start Date, defined 97

R
R01, defined 109
randomized controlled trial allocation method,
defined 95
Ready for PDQ Abstraction Date, defined 97
Ready for QC Date, defined 97
registering
batches of trial amendments 87
batches of trials 87
new users 6
trials 28
trials, proprietary 52

registration, user account 6
rejected trial, defined 109
required documents 51
for batch uploads 67

requirements
data, for batch uploads 68

responsible party
section, completing 35

responsible party, defined 103
RRP, defined 109
rules
amendment‐specific 78
for batch uploads 68
for participating sites documents 93
for submitting proprietary trial data 90
for trial status dates 44

S
safety/efficacy study, defined 104
safety study, defined 104
Scientific 98
Scientific Processing Completed Date,
defined 98
Scientific Processing Start Date, defined 97
screening trial, defined 102
search results
data displayed 20

single blind masking, defined 97
single group intervention model, defined 96
sponsor, defined 109
SPORE, defined 109
status
see also trial status 106
user view criteria 19

114

section, amending 79
section, completing 44, 57

study classification, defined 104
Submission Acceptance Date, defined 97
Submission Received Date, defined 97
Submission Rejection Date, defined 97
Submitter Trial Summary Report Feedback Date,
defined 97
submitting new trials 28
Summary 4
section, amending 79
section, completing 38, 56
sponsor/source, defined 104

Summary 4 funding category 38
defined 104
externally peer‐reviewed, defined 104
industrial defined 104
institutional, defined 104
national, defined 104

supported browsers 5
supportive care trial, defined 102

T
templates

downloading 10, 11
for batch uploads 12
for participating sites 11
for proprietary trials 11

templates and resources 10
treatment trial, defined 17, 101
trial
amendments, introduction to 74
completing details section 31, 55
data required, for participating sites 94
data specifications, non‐proprietary trials 89
details, editing 29
details, printing 30
identification section, completing 54
ownership 19
ownership, of batch files 90
ownership, transferring 85
phases, defined 105
phases of 31
processing statuses 19
status categories 45
updates, introduction to 71
validation 18

trial‐related documents
preparation for batch upload 88
section, completing 51, 57
see also, documents 51
uploading 51, 58

trials
amending 76
editing 29
printing 30
registering batches of 66
searching for 16
transferring ownership of 85
updating 72
viewing details 22

TRP, defined 109, 110
TSR
content of 75
defined 110
in amendment process 75

U
updates
editing 81
printing 82
reviewing 81

trial status
approved, defined 106
closed to accrual, defined 106
closed to accrual and invention, defined 106
complete, defined 106
date rules for 44
defined 109
temporarily closed to accrual, defined 106
temporarily closed to accrual and invention,
defined 106

Trial Summary Report Sent Date, defined 97
trial type
ancillary, defined 17
basic science, defined 17
correlative, defined 17, 102
defined 106, 110
diagnostic, defined 17, 102
early detection, defined 17, 102
epidemiologic, defined 17
expanded access, defined 17
health services research 17
observational, defined 17, 18
outcome, defined 17
prevention, defined 17
screening, defined 17
supportive care, defined 17
treatment, defined 17

updating trials 72
uploading
amendment‐specific documents 80
batches 67

URI, defined 110
URL, defined 110
user
registration 6
roles 19

user account
managing 83
password management 84

V
validated trial, defined 110
validated trials 18

X
XML, defined 110

Z
zip, defined 110

115

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116

File Type	application/pdf
File Title	NCI CTRP Registration Site v.3.1 User's Guide
Subject	508 compliant
Author	NCI CBIIT - Lauren Anthone
File Modified	2010-01-13
File Created	2010-01-13