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NCI CLINICAL TRIALS
REPORTING PROGRAM
REGISTRATION SITE
User’s Guide v. 2.0

Center for Biomedical Informatics
and Information Technology

This is a U.S. Government work.

May 20, 2009

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

Chapter 1
Getting Started ........................................................................................7
About the CTRP Registration Site ....................................................................... 7
Creating an Account ............................................................................................. 8
Logging In to the CTRP Registration Site ........................................................ 10
Using CTRP Trial Registration Templates and Resources ............................ 11
Downloading Trial Registration Templates .............................................. 11
Using the Proprietary Trial Template ........................................................ 12
Using the Participating Sites Template ...................................................... 12
Using the Batch Upload Template .............................................................. 13

Chapter 2
Searching For Trials ..............................................................................15
About Clinical Trial Metadata ........................................................................... 15
Searching For Trials ............................................................................................ 15
Working with Search Results ............................................................................. 18
Navigating Through the Search Results List ............................................. 19
Viewing Trial Details .......................................................................................... 20
Viewing Trial-Related Documents .............................................................. 20

Chapter 3
Registering New Trials ........................................................................23
Registering Trials in the CTRP Registration Site ............................................ 23
Completing the Trial Details Section .......................................................... 25

This is a U.S. Government work.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Completing the Lead Organization/Principal Investigator Section ....... 28
Completing the Sponsor/Responsible Party Section ................................ 28
Completing the Summary 4 Information Section ..................................... 29
Completing the NIH Grant Information Section ...................................... 30
Completing the Trial Status/Dates Section ................................................ 35
Completing the IND/IDE Information Section ......................................... 36
Registering IND Trials .............................................................................. 37
Registering IDE Trials ............................................................................... 38
Completing the Trial Related Documents Section ................................... 40
Registering Organizations .................................................................................. 41
Searching for Registered Organizations .................................................... 42
Adding Organizations .................................................................................. 44
Registering Persons ............................................................................................. 45
Searching for Principal Investigators ......................................................... 45
Adding Principal Investigators ................................................................... 47
Registering Multiple Trials in a Batch .............................................................. 49
Data Requirements for Batch Uploads ....................................................... 50

Chapter 4
Amending Registered Trials ...............................................................53
About Trial Amendments .................................................................................. 53
Amendment Process Life Cycle .................................................................. 54
Amending Verified Trials .................................................................................. 54
Amending Trial Details ................................................................................ 57
Amending Lead Organization and Principal Investigator Details ........ 57
Amending Sponsor and Summary 4 Details ............................................. 58
Amending NIH Grant Details ..................................................................... 58
Amending Trial Status Dates ....................................................................... 58
Amending IND/IDE Details ......................................................................... 59
Uploading Amendment-Specific Documents ........................................... 59
Reviewing and Submitting Amended Trials ................................................... 60
Editing Amendment Details ........................................................................ 60
Printing Amended Trial Information ......................................................... 61

Chapter 5
Managing Your Account ......................................................................63
Editing User Information ................................................................................... 63
Managing Your Password .................................................................................. 64
Changing Your Password ............................................................................ 64
Resetting Your Password ............................................................................. 64

This is a U.S. Government work.

Appendix A
Metadata Definitions ...........................................................................65
Appendix B
Batch Upload Data Specifications .....................................................75
Preparing the Trial Data File .............................................................................. 75
Preparing Trial-Related Documents ................................................................. 76
Trial Data Element Specifications ..................................................................... 77

Appendix C
Participating Sites Document Specifications ..................................79
Participating Sites Document Rules .................................................................. 79
Participating Site Data Element Specifications ............................................... 80

Glossary ..................................................................................................81
Index ........................................................................................................85

This is a U.S. Government work.

iii

NCI Clinical Trials Reporting Program Registration Site User’s Guide

This is a U.S. Government work.

ABOUT THIS GUIDE
This chapter introduces you to the NCI Clinical Trials Reporting Program Registration
Site User’s Guide. It includes the following topics:
z

Purpose on this page

Audience on this page

Topics Covered on this page

Text Conventions Used on page 2

Credits and Resources on page 3

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 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 are new to the CTRP Registration Site, read this brief overview, which explains
what you will find in each chapter.
z

Chapter 1, Getting Started, on page 7 introduces you to the CTRP Registration
Site and provides instructions for registering for an account and for logging in to
the system.

Chapter 2, Searching For Trials, on page 15 describes how to search for,
submit, and view trials in the CTRP Registration Site.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Chapter 3, Registering New Trials, on page 23 describes how to submit, or
register, trials using the CTRP Registration Site.

Chapter 4, Amending Registered Trials, on page 53 describes how to submit
amendments to trials currently registered and verified in the CTRP.

Chapter 5, Managing Your Account, on page 63 provides instructions for
modifying your CTRP Registration Site account.

Appendix A, Metadata Definitions, on page 65 defines the metadata associated
with trials and provides examples of valid values for trial details.

Appendix B, Batch Upload Data Specifications, on page 75 describes how to
prepare your trial data and documents. It also provides data specifications for
the trial data.

Appendix C, Participating Sites Document Specifications, on page 79 provides
the specifications—rules, formats, requirements, etc.—for Participating Sites
documents.

Glossary provides definitions of acronyms, abbreviations, and terminology used
in this guide.

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.

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
monospace 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.
CTRP Registration Site Development and Management Teams
Development

Documentation

Project and Product
Management

Smita Hastak5

Lauren Anthone2

John Speakman1

Nelli Shemko5

Jill Hadfield1

Christo Andonyadis1

Lisa Schick5

Quality Assurance

Charlie Mead6

Wendy Ver Hoef5

Paula Brown8

Nancy Roche7

Todd Parnell4

Sohal Shah8

Edmond Mulaire3

Paul Boyes6

Jyothsna Chilukuri7

Kevin Stern6

John Koisch6

Kavitha Thulasiraman7

Rebecca Teague6

Naveen Amiruddin5

Ujala Kapoor9

Scott Miller4
Bala Nair5
Hugh Reinhart5
Harsha Jayanna5
Kalpana Guthikonda5
Steve Matyas4
Leslie Powers4
Gax Ayalew4
Hong-Qiang Gao5
Steve Lustbader4
1

National Cancer Institute
Center for Biomedical
Informatics and Information
Technology (NCI-CBIIT)
2 Lockheed Martin

SemanticBits
4 5AM Solutions
5
ScenPro, Inc.
6 Booz Allen Hamilton

Science Application
International Corporation (SAIC)
8 Ekagra
9 NARTech

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Key Contributors
Troy Budd3

Jeff Shilling4

Steve Friedman5

John Speakman1

Lakshmi Grama2

Pat Winkler6

Beverly Meadows3

Jo Anne Zujewski5

Elizabeth Nesse4

Kumar Chandran7

National Cancer Institute Center for Biomedical
Informatics and Information Technology (NCICBIIT)
2 Office of Communications and Education (OCE)
3 Division of Cancer Prevention (DCP)

Center for Cancer Research (CCR)
Cancer Therapy Evaluation Program (CTEP)
6 Cancer Centers Branch (CCB)
7
Capital Technology Information Services,
Inc.(CTIS)
5

References
Protocol definitions

http://clinicaltrials.gov

http://www.cancer.gov/dictionary/
db_alpha.aspx?expand

http://prsinfo.clinicaltrials.gov/fdaaa.html

http://www.cancer.gov/ncictrp

http://www.cancer.gov/clinicaltrials/ctrp/page12

Application Support
For technical assistance when registering your trials with CTRP, or for any general
information about the application, application support, or to report a bug, contact
National Cancer Institute Center for Biomedical Informatics and Information
Technology (NCI-CBIIT) (formerly, NCICB) Application Support.

Email: [email protected]
(mailto:[email protected])

When submitting support requests via email, please
include:
z
Your contact information, including your
telephone number.
z
The name of the application/tool you are using
z
The URL if it is a Web-based application
z
A description of the problem and steps to
recreate it.
z
The text of any error messages you have
received

Application Support URL

http://ncicb.nci.nih.gov/NCICB/support

Telephone: 301-451-4384
Toll free: 888-478-4423

Telephone support is available:
Monday to Friday, 8 am – 8 pm Eastern Time,
excluding government holidays.

For business, process, and other general questions about CTRP, send an email to
[email protected] (mailto:[email protected]).

NCI Clinical Trials Reporting Program Registration Site User’s Guide

CHAPTER

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:
z

About the CTRP Registration Site on this page

Creating an Account on page 8

Logging In to the CTRP Registration Site on page 10

Using CTRP Trial Registration Templates and Resources on page 11

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 trials one-at-a-time, or in batches
consisting of multiple trials. For information on registering single trials, see Chapter 3,
Registering New Trials, on page 23. For information on registering multiple trials, see
Registering Multiple Trials in a Batch on page 49.
Currently you can register interventional trials. Future releases of this produce 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 Clinical Trials Reporting Program Registration Site User’s Guide

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
multiple new trials that were conducted at a given site. Follow instructions in
Registering Multiple Trials in a Batch on page 49
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.

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

Chapter 1 Getting Started
o

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.

Figure 1.3 My Account page
7. Complete the remaining personal information fields. 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 zip
code “None.”
8. In the Organization Affiliation field, type the name of the organization you are
affiliated with.
9. Click Submit.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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.
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.

Chapter 1 Getting Started

Note: If you have forgotten your password, see the instructions in Resetting
Your Password on page 32.
4. Click Login.
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:
z

Editing User Information

Resetting Your Password

Searching For Trials

Viewing Trial Details

Adding New Trials

About the CTRP Registration Site

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, 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.

Downloading Trial Registration Templates
You can download the following templates from the CTRP website:
z

Registry_Proprietary_Trial_Template.xls – Use this template to
record proprietary trial data for non-NCI trials for which there are no protocol
documents.

CTRP_Participating_Sites_Template.xls – Use this template to
record participating site data, especially if site-specific data is not included in the
trial protocol, or if you need to make changes to the original participating sites
information.

CTRP_Registry_Batch_Upload.xls – Use this template as a guide to
record trial data required for registering multiple trials in batches.

How to Download CTRP Templates
1. Navigate the CTRP website at http://www.cancer.gov/clinicaltrials/ctrp.
11

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Tip:

Click the Resources and Templates quick link on the CTRP Registration
Site navigation pane to jump to the template download page.

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 http://ncicb.nci.nih.gov/NCICB/support.

Using the Proprietary Trial Template
The proprietary trial template is designed primarily for industry-lead or other trials that
are not supported by the NCI, which cannot supply a protocol document.
The CTRP Registration Site contains some data fields that are mandatory for
registration of NCI-supported trials but which are not applicable to proprietary trial
registrations.
In order to satisfy system requirements, use the following work-arounds when entering
proprietary trial data through the CTRP Registration Site:
z

Leave non-applicable optional fields blank (e.g., grant information)

Upload protocol and other related documents

If you are not able to provide a trial protocol document, complete the CTRP
Proprietary Trial Worksheet tab

If the trial has already been registered in ClinicalTrials.gov, include the Clinical
Trials ID (NCT number) on the worksheet

Upload the CTRP Proprietary Trial Data Entry Template in place of the protocol

Using the Participating Sites Template
The participating sites template is designed for recording participating site data,
especially if site-specific data is not included in the trial protocol. The participating site
document includes participating site information and collaborator information. See
Participating Sites Document Specifications on page 79.
Rules for completing participating site documents are as follows:
z

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 contact information

Participating site data must include the following data elements:
o

Organization attribute

Current recruitment status

Status date

Chapter 1 Getting Started
o

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.
z

Participating site contact information is optional if the contact person is the
investigator

If the contact person is the investigator, the participating site data and study site
investigator's information are mandatory

Using the Batch Upload Template
The Batch Upload Template contains the trial elements required for registration,
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.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

CHAPTER

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

About Clinical Trial Metadata on this page

Searching For Trials on page 15

Working with Search Results on page 18

Viewing Trial Details on page 20

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 A, Metadata Definitions, on page 65 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.

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 8.
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 17All
registered users can search trials with the “Validated” processing status. Additionally,
you can search trials that you registered, but not validated. These trials are indicated by
the “Submitted” status.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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.

Phase

Select the trial phase from the drop-down menu.
z

Phase 0

Phase I

Phase I/II

Phase II

Phase II/III

Phase III

Phase IV

Pilot

N/A

Other

Table 2.1 Trial Search Criteria

Chapter 2 Searching For Trials

To search by this...

Do this...

Purpose

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

Identifier Type

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.
z

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 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)
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.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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.

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,” otherwise
they assign the status “rejected.” In the event that your submission is “rejected,” the
CTRP sends you an email message indicating the status and reason for the rejection.
Note: If notified about a rejected trial, trial submitters 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:
z

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:
z

Submitter – User who submitted the trial

Other user – Any user other than the submitter

Trial ownership categories are as follows:
z

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
Status

Definition

Which roles can
see this trial in
the list?

Listed in
“My
Trials?”

Submitted

Trial submitted but not validated

Submitter

Yes

Rejected

Trial did not pass validation

No one

Accepted

Trial passed validation

Submitter

Other users

Table 2.2 Processing statuses of trials in the CTRP Registration Site

Yes

Chapter 2 Searching For Trials

Processing
Status

Definition

Which roles can
see this trial in
the list?

Abstracted

Trial has been abstracted

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

Abstraction
Verified No
Response

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

Submitter

Other users

Listed in
“My
Trials?”
Yes
Yes

Yes

Table 2.2 Processing statuses of trials in the CTRP Registration Site

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:
z

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.

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.

Action – When “Amend” appears in this column, an amendment to the trial can
be submitted.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

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 Trial Details page displays the metadata as entered by a trial submitter. Refer to
Appendix A, Metadata Definitions, on page 65 for a description of the metadata.
Note: Responsible party, IND/IDE, NIH grant information and trial-related documents are
only displayed for the private trials.

Viewing Trial-Related Documents
Only submitters can view/download trial-related documents.
How to Download Trial-Related Documents
1. Click the NCI Trial Identifier hypertext link associated with the trial of interest.

Chapter 2 Searching For Trials

The metadata for the selected trial is displayed in a new page.
2. In the Trial Related Documents section at the bottom of the page, click
hypertext link associated with the document of interest.
A dialog box appears in which you are given the option to open the document or
save it to location of your choice.
3. Follow the instructions for your browser and operating system to view or save
the document.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

CHAPTER

REGISTERING NEW TRIALS
This chapter describes how to register trials using the CTRP Registration Site.
This chapter includes the following topics:
z

Registering Trials in the CTRP Registration Site on this page

Registering Organizations on page 41

Registering Persons on page 45

Registering Multiple Trials in a Batch on page 49

Registering Trials in the CTRP Registration Site
The CTRP Registration Site provides a user-friendly interface through which you can
register new and amended trials in the CTRP system. Additionally, when your
registration is verified, you will receive a Trial Summary Report—a system-generated
report that contains all your abstracted data—in both MS Word and XML formats. The
later is formatted to facilitate the registration of your trials with the Library of Medicine's
ClinicalTrials.gov database.
Tip:

Before you begin to register a trial, ensure that the trial does not exist in the system
already. You can do this by searching for trials using any of the criteria as per the
instructions in Searching For Trials on page 15.

Note: You are required to provide information for all fields marked with an asterisk (*).
See the following topics for more detailed instructions and definitions:
z

Completing the Trial Details Section on page 25

Completing the Lead Organization/Principal Investigator Section on page 28

Completing the Sponsor/Responsible Party Section on page 28

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Completing the Summary 4 Information Section on page 29

Completing the NIH Grant Information Section on page 30

Completing the Trial Status/Dates Section on page 35

Completing the IND/IDE Information Section on page 36

Completing the Trial Related Documents Section on page 40

How to Submit a Trial
1. On the navigation pane on the left side of the page, click Register Trial.
The Register Trial page appears (Figure 3.1).

Figure 3.1 Register Trial Page – Upper Section
2. Type the appropriate information in the text fields, or select options from the
drop-down lists as appropriate.
3. Scroll to the bottom of the Register 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.
4. Correct any errors if indicated, and repeat the previous step as many times as
necessary until the trial is error-free.
Note: The Review Trial Details page is read-only. To edit information that you
have reviewed, see Editing Amendment Details on page 60.
5. Click Submit.

Chapter 3 Registering New Trials

The system sends you an email message to acknowledge that the trial has
been submitted. After submission, no other users can see the trial information
you provided until the information has been validated. If the trial is rejected at
validation, the system alerts you via a rejection message. Once validated, the
trial you submitted is ready for abstraction by an NCI Clinical Trials Reporting
Office (CTRO) specialist.

Completing the Trial Details Section
You must complete all fields in the Trial Details section (Figure 3.2).

Figure 3.2 Add Trial Page – Trial Details Section
How to Complete the Trial Details Section
1. Type the Lead Organization Trial Identifier in the field provided, or for InterGroup trials, type the Lead Group’s trial number.
Note: The Trial Identifier must be exactly the same as it appears in the protocol
document.
For example:
NSABP-B-40
Note: For multi-site trials that have no assigned single center, use the protocol
ID.
2. Type the Title in the field provided. You can use a maximum of 4000 characters.

For example:
“Study of Recombinant Vaccinia Virus That Expresses Prostate Specific
Antigen in Metastatic Adenocarcinoma of the Prostate”

NCI Clinical Trials Reporting Program Registration Site User’s Guide

3. Select the Trial Phase from the drop-down list. Table 3.1 lists valid trial phases:
Phase #

Definition

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.

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

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.

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.

II/III

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

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.

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

Pilot

Initial study examining a new method or treatment.

N/A

Not applicable

Other

Any phase not listed above

Table 3.1 Trial phase definitions
4. If you selected Other in Step 3, in the Phase Comment field, type a description
about the phase of the trial.
5. The Interventional Trial Type is pre-selected.
Note: Currently you can register interventional trials only. Future releases of
this produce will enable you to register observational trials as well.
6. From the Purpose drop-down list, select the purpose of the trial.

Chapter 3 Registering New Trials

Table 3.2 lists valid values:
Trial Purpose

Definition

Treatment

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

Prevention

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

Diagnostic

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

Early Detection

Clinical trials directly testing the efficacy of devices, techniques,
procedures; or tests for earlier detection or diagnosis of efficacy
of devices, techniques, procedures; or tests for earlier or more
accurate detection or diagnosis of disease.

Basic Science

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

Supportive Care

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

Screening

Protocol 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).

Epidemiologic

Studies among cancer patients and healthy populations that
involve no intervention or alteration in the status of the
participants, e.g., surveillance, risk assessment, outcome,
environmental, and behavioral studies.

Observational

Studies in human beings in which biomedical and/or health
outcomes are assessed in pre-defined groups of individuals.
Subjects in the study may receive diagnostic, therapeutic, or
other interventions, but the investigator does not assign specific
interventions to the subjects of the study

Outcome

Ancillary

Auxiliary studies that are stimulated by, but are not a required
part of, a main clinical trial/study, and that utilize patient or other
resources of the main trial/study to generate information relevant
to it. Ancillary studies included must be linked to an active trial or
epidemiologic or other study and should include only patients
accrued to that trial or study. Only studies that can be linked to
individual patient or participant data should be reported.

Table 3.2 Trial purpose definitions

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Trial Purpose

Definition

Correlative

Laboratory based studies using specimens to assess cancer risk,
clinical outcomes, response to therapies, etc. Only studies that
can be linked to individual patient or participant data should be
reported.

Health Services
Research

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

Other

Any trial type not included in this list.

Table 3.2 Trial purpose definitions (Continued)
7.

If you selected Other in Step 6, in the Purpose Comment field, describe the
purpose of the trial.

Completing the Lead Organization/Principal Investigator Section
You must complete both fields in the Lead Organization/Principal Investigator section
(Figure 3.3).

Figure 3.3 Add Trial Page – Lead Organization/Principal Investigator Section
How to Complete the Lead Organization/Principal Investigator Section
1. Look up the Lead Organization and select the appropriate organization from the
list of search results. If your trial’s lead organization is not listed, you can
register it in the system at this point. To search for and register an organization,
follow the instructions in Searching for Registered Organizations on page 42
and Adding Organizations on page 44.
2. Look up the Principal Investigator and select the appropriate name from the list
of search results. If your trial’s principal investigator’s name is not listed, you
can register it in the system at this point. To search for and register an
investigator, follow the instructions in Searching for Principal Investigators on
page 45 and Adding Principal Investigators on page 47.

Completing the Sponsor/Responsible Party Section
You must complete all fields in the Sponsor/Responsible Party section (Figure 3.4).

Figure 3.4 Add Trial Page – Sponsor/Responsible Party Section
28

Chapter 3 Registering New Trials

How to Complete the Sponsor/Responsible Party Section
1. Look up the Sponsor and select the appropriate sponsor organization from the
list of search results. If your trial’s sponsor is not listed, you can register it in the
system at this point. To search for and register a sponsor, follow the instructions
in Searching for Registered Organizations on page 42 and Adding
Organizations on page 44.
2. Indicate the party who is responsible for the trial. Select one of the following
options:
o

PI (principal investigator) – Primary medical researcher in charge of carrying
out a clinical trial's protocol.

- oro

Sponsor – Name of primary organization that oversees implementation of
study and is responsible for data analysis.

3. If you selected Sponsor in the previous step, the Sponsor/Responsible Party
section (Figure 3.5) expands to display the Responsible Party Contact. Follow
the instructions in Looking Up Registered Persons on page 123 to record the
responsible party contact person information.

Figure 3.5 Add Trial Page – Sponsor Section, Expanded
4. In the Email Address and Phone Number fields, type the responsible party’s
contact email address and phone number. You can use spaces or dashes, or
no separators at all in the Phone Number fields. Include numbers only for
phone number extensions where applicable.
Caution: Do not add spaces in the phone number.

Completing the Summary 4 Information Section
If the lead organization or at least one participating site is a NCI designated cancer center,
complete both fields in the Summary 4 Information section (Figure 3.6).

Figure 3.6 Add Trial Page – Summary 4 Information Section

NCI Clinical Trials Reporting Program Registration Site User’s Guide

How to Complete the Summary 4 Information Section
1. Select the Summary 4 Funding Category from the drop-down list. Table 3.3 lists
valid categories:
Funding
Category

Definition (For clinical trials involving an agent or device or
other intervention)

National

National Cooperative Group Trials

Externally
Peer-Reviewed

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

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.

Industrial

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

Table 3.3 Summary 4 funding categories definitions
2. Look up the Summary 4 Funding Sponsor/Source and select the appropriate
organization from the list of search results. If your trial’s lead organization is not
listed, you can register it in the system at this point. To search for an
organization, follow the instructions in Searching for Registered Organizations
on page 42. To register an organization, follow the instructions in Adding
Organizations on page 44.

Completing the NIH Grant Information Section
If your trial includes an NIH grant, record the funding mechanism, institute code, serial
number, and NCI division/program for this grant (Figure 3.7). You can add multiple NIH
grants.
An NIH grant identification number consists of several parts, each having a distinct
meaning.
For example:
1R01CA009999-08A1S2
where,
1 is the single-digit code identifying the type of application received and processed
R01 (position 2 - 4) is the three-digit code identifying a specific category of extramural
activity. It corresponds to Funding Mechanism element in the NIH grant information
section.
CA (position 5 - 6)is the two-letter code identifying the assignment or funding NIH
Institute or Center. It corresponds to Institute Code element in the NIH grant
information section.

Chapter 3 Registering New Trials

009999 (position 7 - the dash) is the five- or six-digit number generally assigned
sequentially to a series within an Institute, Center, or Division. It corresponds to the
Serial Number element in the NIH grant information section.
- (dash) 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
identifing a particular supplemental record.
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.
For a complete guide to NIH grant information, see the following web pages:
z

http://ocga3.ucsd.edu/Proposal_Preparation/Federal/NIH/Grants/Basics/
NIH_Grants_Grant_Identification_Numbering_System.htm

http://grants1.nih.gov/grants/funding/ac.pdf

http://deais.nci.nih.gov/Query/search/

Figure 3.7 Add Trial Page – NIH Grant Information Section
How to Complete the NIH Grant Information Section
1. Type the initial letter(s) and or number(s) in the Funding Mechanism field and
then select the funding mechanism code from the drop-down list.
Tip:

Click the down arrow in the field, and then use the up and down arrow
keys on your keyboard to scroll up and down the drop-down list. When
you arrive at the appropriate code, press the ENTER key.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Table 3.4 lists examples of valid codes:
Funding Mechanism

Definition

B09

Mental Health Services Block Grant

C06

Research Facilities Construction Grant

DP1

NIH Director’s Pioneer Award (NDPA)

DP2

NIH Director’s New Innovator Awards

D43

International Training Grants in Epidemiology

D71

International Training Program Planning Grant

X02

Pre-application

Table 3.4 NIH grant funding mechanisms definitions
2. Type the initial letter(s) of the name of the primary organization responsible for
funding the trial in the Institute Code field and then select the institute code
from the drop-down list.
Table 3.5 lists examples of valid codes:
Institute
Code

Definition

National Institute on Alcohol Abuse and Alcoholism

National Institute on Aging

National Institute of Allergy and Infectious Diseases

NIAID Research Support

National Institute of Arthritis and Musculoskeletal and Skin Disease

National Center for Complementary and Alternative Medicine

Table 3.5 NIH institute code definitions
3. Type the six-digit number generally assigned sequentially to a series within an
Institute, Center, or Division, for example, 009999, in the Serial Number field.
4. Type the initial letter(s) of the division or program code in the NCI Division/
Program Code field and then select the code from the drop-down list.

Chapter 3 Registering New Trials

Table 3.6 lists examples of valid codes:
Division/
Program
Code

Definition

CCR

Center for Cancer Research

CTEP

Cancer Therapy Evaluation Program

DCB

Division of Cancer Biology

DCCPS

Division of Cancer Control and Population Sciences

DCEG

Division of Cancer Epidemiology and Genetics

DTP

Developmental Therapeutics Program

DCP

Division of Cancer Prevention

DEA

Division of Extramural Activities

Office of the Director, NCI, NIH

OSB/SPORE

Organ Systems Branch/
Specialized Programs of Research Excellence

CIP

Cancer Imaging Program

CDP

Cancer Diagnosis Program

TRP

Translational Research

RRP

Radiation Research Program

N/A

Not applicable

Table 3.6 NCI Division/Program code definitions
5. Click Add Grant.
Note: The Add Grant button is operable only after you have provided the
grant information in all fields.
The grant is displayed and added to the trial and the Grant fields are reset.

Figure 3.8 Grant Information Section – Registered Grant
6. If your trial is funded by more than one grant, repeat the steps above, and then
click Add Grant.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Another grant record appears.

Figure 3.9 Grant Information Section – Additional Grant
7. To unlink a grant from a trial, in the Action column, click Delete.

Chapter 3 Registering New Trials

Completing the Trial Status/Dates Section
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. The following table provides the rules for trial status dates.
If this is true...

Follow this rule

Trial Start Date is “Actual”

Trial Start Date must be current or in the past

Trial Start Date is “Anticipated”

Trial Start Date must be in the future

If the Primary Completion Date is “Actual”

Trial Start Date must be current or in the past

If the Primary Completion Date is
“Anticipated”

Trial Start Date must be in the future

Current Trial Status Date

Date must be current or in the past

Current Trial Status is “Approved”

Trial Start Date must be “Anticipated”

Current Trial Status is not “Approved”

Trial Start Date must be “Actual”

Current Trial Status is “Completed”

Trial Status Date must be “Actual”

Primary Completion Date must be the same
as Current Trial Status Date

Current Trial Status is “Completed”

Primary Completion Date must be “Actual”

Current Trial Status is “Administratively
Completed”

Primary Completion must be “Actual”

Current Trial Status is neither of the
following:

Primary Completion Date must be “Anticipated”

“Administratively Completed”

“Completed”

Table 3.7 Rules for Status/Dates relationships

Figure 3.10 Add Trial Page – Status/Dates Section
How to Complete the Status/Dates Section
1. Select the trial’s current status from the Current Trial Status drop-down list.
Table 3.8 lists valid categories.
Status

Definition

Approved

Trial has been approved

Active

Trial is open for accrual

Table 3.8 Current trial status definitions
35

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Status

Definition

Closed to Accrual

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

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.

Temporarily Closed to
Accrual

Trial is temporarily not accruing.

Temporarily Closed to
Accrual and Intervention

Trial is temporarily not accruing. Participants are not
receiving intervention.

Administratively
Complete

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

Complete

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

Table 3.8 Current trial status definitions
2. If you selected the Administratively Complete or Temporarily Closed to
Accrual status, in the Why Study Stopped field, type the reason why the study
has ended or not currently accruing.
3. Type the date on which the current trial status became effective in the Current Trial
Status Date field using the mm/dd/yyyy format, or, click the calendar icon ( )
and select the date from the calendar.
4. Type the date on which the trial started, or is expected to start, in the Trial Start
Date field using the mm/dd/yyyy format, or, click the calendar icon ( ) and
select the date from the calendar.
5. Indicate whether the start date is the one on which you expect the trial to start,
or the date on which it actually started, by selecting either Anticipated or
Actual.
6. Type the date on which the trial ended, or is expected to end, in the Primary
Completion Date field using the mm/dd/yyyy format, or, click the calendar icon
( ) and select the date from the calendar.
7. Indicate whether the completion date is the one on which you expect the trial to
end, or the date on which the trial actually ended by selecting either
Anticipated or Actual.

Completing the IND/IDE Information Section
Complete the IND/IDE number and grantor fields only if your trial is/was conducted in
the United States. You must indicate whether your trial qualifies as an Investigational
New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.
To register IND trials, see Registering IND Trials on page 37.
To register IDE trials, see Registering IDE Trials on page 38.
36

Chapter 3 Registering New Trials

Registering IND Trials
There are several dependencies between elements in the IND/IDE section
(Figure 3.11). Follow the instructions below in the order in which they are presented.
How to Register IND Trials
1. In the IND/IDE Types column, select the IND.

Figure 3.11 Add Trial Page – IND/IDE Section
2. In the IND/IDE Number field, type the IND number associated with the trial.
3. From the IND/IDE Grantor drop-down list, select the IND grantor.
Note: The list of grantors varies depending on the selected IND/IDE type.
Table 3.9 lists valid grantors.
Valid Grantors
CDER – Center for Drug Evaluation and Research
CBER – Center for Biologics Evaluation and Research
CDRH – Center for Devices and Radiological Health

Table 3.9 Valid grantors
4. From the IND/IDE Holder Type drop-down list, select the holder type from the
IND/IDE Holder Type drop-down list.
Table 3.10 lists valid holder types.
Valid Holder Types
Investigator
Organization
Industry
NIH
NCI

Table 3.10 Valid holder types
Note: If you select either NCI or NIH, you must select the NIH or NCI Division/
Program code.

5. If you selected either NIH or NCI, from the NIH Institution, NCI Division/
Program Code drop-down list, select the appropriate institute code.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

6. In the Expanded Access column, indicate whether or not an experimental drug
or device is available outside any clinical trial protocol by selecting either Yes or
No.
7. Do one of the following:
o

If you selected No, click Add IND/IDE.

- oro

If you selected Yes, select the status of the drug or device access from the
Expanded Access Status field, and then click Add IND/IDE.
Table 3.11 lists valid states.
Status

Definition

Available

Expanded access is currently available for this treatment

No Longer Available

Expanded access was available for this treatment
previously but is not currently available and will not be
available in the future

Temporarily not available

Expanded access is not currently available for this
treatment, but is expected to be available in the future

Approved for marketing

This treatment has been approved for sale to the public

Table 3.11 Valid values for expanded access status
8. Optionally, to add another IND/IDE, repeat the steps above.

Registering IDE Trials
Due to several IND/IDE element dependencies, follow the instructions below in the
order in which they are presented.
How to Register IDE Trials
1. In the IND/IDE Types column, select the IDE (Figure 3.12).

Figure 3.12 Add Trial Page – IND/IDE Section
2. In the IND/IDE Number field, type the IDE number associated with the grant.
3. From the IND/IDE Grantor drop-down list, select CDRH (CDRH – Center for
Devices and Radiological Health).
4. From the IND/IDE Holder Type drop-down list, select the holder type from the
IND/IDE Holder Type drop-down list.

Chapter 3 Registering New Trials

Table 3.12 lists valid holder types.
Valid Holder Types
Investigator
Organization
Industry
NIH
NCI

Table 3.12 Valid holder types
Note: If you select either NCI or NIH, you must select the NIH or NCI Division/
Program code.

5. If you selected either NIH or NCI, from the NIH Institution, NCI Division/
Program Code drop-down list, select the appropriate institute code. See
Appendix A, Metadata Definitions, on page 65 for valid Institute codes.
6. Indicate whether or not an experimental drug or device is available outside any
clinical trial protocol by selecting either Yes or No.
7. Do one of the following:
o

If you selected No, proceed to Step 8.

- oro

If you selected Yes, select the status of the drug or device access from the
Expanded Access Status field, and then click Add IND/IDE.
Table 3.13 lists valid states.
Status

Definition

Available

Expanded access is currently available for this treatment

No Longer Available

Expanded access was available for this treatment
previously but is not currently available and will not be
available in the future

Temporarily not available

Expanded access is not currently available for this
treatment, but is expected to be available in the future

Approved for marketing

This treatment has been approved for sale to the public

Table 3.13 Valid values for expanded access status
8. To add the IND/IDE information to the trial, click Add IND/IDE.
Note: The Add IND/IDE button is operable only after you have provided
information in all fields.
The IND/IDE record is displayed and added to the trial.
Tip:

If the IND/IDE information is incorrect, delete the record and add it
again with the correct information.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

9. If your trial is includes more than one IND/IDE, repeat the steps above, and then
click Add IND/IDE.
Another IND/IDE record appears (Figure 3.13).

Figure 3.13 Grant Information Section – Additional Grant
10. To delete an IND/IDE record from a trial, in the Action column, click Delete.

Completing the Trial Related Documents Section
You must include each of the following types of documents in order to register your
trial:
z

For non-industry trials only: Complete protocol

For industrial trials only: Summary of the proprietary protocol

IRB approval

Informed Consent (if not included in the protocol document)

Participating sites (if not included in the protocol document)

Note: If the Informed Consent and Participating Sites documents are not
included as part of the protocol document, upload them separately as
“Trial Related Documents.”
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.

Figure 3.14 Add Trial Page – Trial Related Documents

Chapter 3 Registering New Trials

Note: The procedure for uploading documents is the same for all document types.
How to Submit Trial Related Documents
1. Click the Browse button beside the Protocol Document field.
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 these steps above for each type of document.
4. When you have completed all fields, click Submit Trial.
The Trial Details page appears. It contains a message that you have created
your trial successfully (if appropriate), and lists the details of the trial you just
submitted. It also provides the assigned NCI Identification number. In case of
incomplete submission, the message prompts you to complete required fields.

Figure 3.15 Trial Details Page After Successful Submission – Lower Sections
5. Optionally, to view the trial related documents, click the document links.

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

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Registered Organizations on page 42.) If your search results do not contain the name
of your organization, you can register a new one. (See Adding Organizations on
page 44.)

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

Figure 3.17 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 the initial character, or series of characters in the Name,
City, or Zip fields to narrow the search results, but do not use wildcard
symbols (*). For example, to search for organizations in Rockville only,
type R, So, or Roc in the City field.

Chapter 3 Registering New Trials

Note: You must enter search criteria in at least one field.
4. Click Search.
The Search Organizations window displays the results of your search.

Figure 3.18 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 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 3.18, Search Organizations Window – Search Results, on page 43.
7. Scroll through the results list until you locate your organization, and then click
Select.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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 44.

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 3.19 Lead Organization/Principal Investigator Section
2. Next to the Lead Organization field, click Look Up.
The Organization Lookup page appears.

Figure 3.20 Organization Lookup Page – Search for an Organization
3. Click Add Org.
The Add Organization window appears.

Chapter 3 Registering New Trials

Figure 3.21 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.

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 45.) If your search results do not contain the name of
your investigator, you can register a new one. (See Adding Principal Investigators on
page 47.)

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 47.
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.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Figure 3.22 Lead Organization/Principal Investigator Section
2. Next to the Principal Investigator field, click Look Up.
The Select Principal Investigator page appears.

Figure 3.23 Select Principal Investigator Page – Search Persons
3. Provide as much information as you can about your investigator.
Tip:

You can type the initial character, or series of characters in either of the
Name fields to narrow the search results, but do not use wildcard
symbols (*). For example, to search for an investigator whose last name is
Slocum, type S, Sl, or Slo in the Last Name field.

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.

Chapter 3 Registering New Trials

Figure 3.24 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.

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.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

Figure 3.26 Select Principal Investigator Page – Search Persons
3. Click Add Person.
The Add Person window appears.

Figure 3.27 Add Person Window
4. Type or select as much information as possible in the fields provided. You must
complete all required fields, marked with an asterisk (*).
5. Click Save.

Chapter 3 Registering New Trials

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.

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 trials that were conducted at a given site.
Note: The CTRP provides you with the link to the batch upload website when it issues to
authorization to upload batches.
In the current release, you can supply a single grant, a single IND/IDE, and a maximum
of 5 trial documents.
You must upload each of the following types of files when you register multiple trials:
z

Data documents – Documents that contain all the requisite information about
the protocol. See Data Requirements for Batch Uploads on page 50 and
Appendix B, Batch Upload Data Specifications, on page 75.
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 3.28 Batch Trial Upload Page
2. In the Organization Name field, type the name of the organization associated
with the trials you want to register.
49

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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 50.
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.

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 B, Batch Upload Data Specifications,
on page 75.
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

Table 3.14 Data element requirements based on selected values
50

Chapter 3 Registering New Trials

If you provide this value...

You must also provide/select this

(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

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”

Current Trial Status =/ “Approved”

Trial Start Date type = “Actual”

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 (Continued)

NCI Clinical Trials Reporting Program Registration Site User’s Guide

CHAPTER

AMENDING REGISTERED TRIALS
This chapter describes how to make amendments to trials currently registered and
verified in the CTRP, and how to submit the amended trials using the CTRP
Registration Site.
This chapter includes the following topics:
z

About Trial Amendments on this page

Amending Verified Trials on page 54

Reviewing and Submitting Amended Trials on page 60

About Trial Amendments
The CTRP Registration Site enables you, in the role of trial submitter, to amend 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.
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.
Related topics:
z

Amendment Process Life Cycle

Amending Verified Trials

Uploading Amendment-Specific Documents

Reviewing and Submitting Amended Trials

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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. You submit an amendment to your existing, verified trial to the CTRP.
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) that includes all the newly-modified
data in the CTRP.
4. You review and validate the new TSR and email your approval to the CTRO.
5. The system sends you the verified TSR in MS Word and XML formats.
6. The amended trial appears in your Search My Trials results list and is again
available for you to amend throughout the life of your trial.
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:
z

Amending Verified Trials

Uploading Amendment-Specific Documents

Reviewing and Submitting Amended Trials

Amending Verified Trials
In your role as submitter, you can amend only those trials that you have submitted and
appear in search results when using the Search My Trials feature. See Searching For
Trials on page 15.
Note: Only a person who is linked to a trial can submit an amendment in place
of the original submitter. See Adding Principal Investigators on page 47.
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).

Chapter 4 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 19.
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).

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Figure 4.3 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 Trials in the CTRP Registration Site on page 23. Amendment-specific
rules, values, etc., are provided for each section of the Amendment Trial page as
follows:

Amending Trial Details on page 57

Amending Lead Organization and Principal Investigator Details on page 57

Chapter 4 Amending Registered Trials

Amending Sponsor and Summary 4 Details on page 58

Amending NIH Grant Details on page 58

Amending Trial Status Dates on page 58

Amending IND/IDE Details on page 59

Uploading Amendment-Specific Documents on page 59

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 25.
Note: You cannot change an NCI trial identifier number.
Related topics:
z

Amending Verified Trials

Amending Lead Organization and Principal Investigator Details

Amending Sponsor and Summary 4 Details

Amending NIH Grant Details

Amending Trial Status Dates

Amending IND/IDE Details

Uploading Amendment-Specific Documents

Amending Lead Organization and Principal Investigator Details
Only a person who is linked to a trial can submit an amendment in place of the original
submitter or principal investigator (PI). You can amend the PI information so that a
person who may be taking over the role from the current submitter/PI can submit
amendments in the future.
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 28.
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:
z

Amending Verified Trials

Amending Trial Details

Amending Sponsor and Summary 4 Details

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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 Lead Organization/Principal Investigator
Section on page 28.
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:
z

Amending Verified Trials

Amending Lead Organization and Principal Investigator Details

Amending Verified Trials

Amending Lead Organization and Principal Investigator Details

Amending NIH Grant Details
You can create a new NIH grant record only if you can provide all of the following
details:
z

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 30.
Note: You cannot change an existing NIH grant number.
Related topics:
z

Amending Verified Trials

Amending Sponsor and Summary 4 Details

Amending IND/IDE Details

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 35.
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 35.
Related topics:
z

Amending Verified Trials

Chapter 4 Amending Registered Trials

Reviewing and Submitting Amended Trials

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 36.
Note: You cannot change an existing IND/IDE serial number.
Related topics:
z

Amending Verified Trials

Amending Sponsor and Summary 4 Details

Amending NIH Grant Details

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

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:

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:
z

PDF

MS Word

MS Excel

Correl 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
amendment-related documents. See Completing the Trial Related Documents Section
on page 40.
Note: You cannot update or delete existing documents.
Related topics:
z

Amending Verified Trials

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Amending Trial Details

Amending Trial Status Dates

Reviewing and Submitting Amended Trials
After you have completed amending the trial information, review the amendment for
errors and edit any details that do not match the changes in your change memo or
amended protocol document. You can print a copy of the Amendment Trial page to
facilitate the review and/or keep for your records.
How to Review and Submit Amended Trials
1. Complete all modifications to the most recent trial submission.
2. Scroll to the bottom of the Amendment Trial page, and click Review Trial.
The system checks for errors and missing information and displays the results
in a message at the top of the Review Trial Details page. Indicators mark
specific fields that you must complete or correct in order to submit the trial.
3. Correct any errors if indicated, and repeat the previous step as many times as
necessary until the amendment is error-free.
Note: The Review Trial Details page is read-only. To edit information that you
have reviewed, see Editing Amendment Details on page 60
4. Click Submit.
Related topics:
z

Amending Verified Trials

Editing Amendment Details

Printing Amended Trial Information

Editing Amendment Details
You can edit your amended trial details after you have reviewed them at any time
before you submit the trial to the CTRP.
How to Edit Amendment Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit.
The Amendment Trial page displays all information you have provided in
editable form.
Caution: You must upload the amendment-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 Amended Trials on page 60.
Related topics:
z

Amending Verified Trials

Chapter 4 Amending Registered Trials

Reviewing and Submitting Amended Trials

Printing Amended Trial Information

Printing Amended Trial Information
You can print a copy of the amended trial to facilitate the review and/or keep for your
records. You must review the amendment in order to access the print feature. For
instructions on reviewing the trial, see Reviewing and Submitting Amended Trials on
page 60.
How to Print Amended Trial Information
1. Review the amended trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.
Related topics:
z

Amending Verified Trials

Reviewing and Submitting Amended Trials

Editing Amendment Details

NCI Clinical Trials Reporting Program Registration Site User’s Guide

CHAPTER

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

Editing User Information on this page

Managing Your Password on page 64

Editing User Information
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. Specify the organization with which you are affiliated.
4. Click Submit Account Updates to save changes to the account information.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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 64 and Resetting Your Password on page 64.

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.

Resetting Your Password
In the event that you can not remember your password, you can request a password
reset.
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 on page 8.

APPENDIX

METADATA DEFINITIONS
The NCI Clinical Trials Reporting Program Trial Registration Site captures trial details,
or metadata, as entered by a trial submitter. Table A.1 describes the metadata
associated with clinical trials.
ALLOCATION
Participant assignment to an intervention group.
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.
Amendment Number
Number that is 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.
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 A.1 Descriptions of trial metadata
65

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

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.
AA – National Institute on Alcohol Abuse
and Alcoholism

HD – National Institute of Child Health and
Human Development (NICHD)

AG – National Institute on Aging

HG – National Human Genome Research
Institute (NHGRI) - formerly NCHGR

AI – National Institute of Allergy and
Infectious Diseases

HL – National Heart, Lung and Blood
Institute (NHLBI)

AO – NIAID Research Support

HS – Agency for Healthcare Research and
Quality (AHRQ) - not a part of NIH

AR – National Institute of Arthritis and
Musculoskeletal and Skin Disease

LM – National Library of Medicine (NLM)

AT – National Center for Complementary
and Alternative Medicine

MD – National Center on Minority Health and
Health Disparities (NCMHD)

CA – National Cancer Institute (NCI)

MH – National Institute of Mental Health
(NIMH)

CC – NIH Clinical Center

NCCAM – National Center for
Complementary and Alternative Medicine

DA – National Institute on Drug Abuse
(NIDA)

NCMHD – National Center on Minority
Health and Health Disparities

DC – National Institute on Deafness and
Other Communication Disorders (NIDCD)

NR – National Institute of Nursing Research
(NINR)

DE – National Institute of Dental and
Craniofacial DK National Institute of
Diabetes and Digestive and Kidney
Diseases

NS – National Institute of Neurological
Disorders and Stroke (NINDS)

EB – National Institute of Biomedical
Imaging and Bioengineering (NIBIB)

OD – Office of the Director

ES – National Institute of Environmental
Health Sciences (NIEHS)

RR – National Center for Research
Resources (NCRR)

EY – National Eye Institute (NEI)

TW – Fogarty International Center (FIC)

GM – National Institute of General Medical Sciences (NIGMS)
INTERVENTION MODEL
Design of an interventional study.

Table A.1 Descriptions of trial metadata (Continued)
66

Appendix A Metadata 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.

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: Inter-Group trials use the lead Groups trial number.
MASKING
Knowledge of intervention assignment
Open – No masking

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.
MILESTONES
Record progress in trial processing and set the trial processing status. Interrelated with onhold states
Submission Received Date – Date the trial
was successfully submitted via the NCI
CTRP Registration Site

QC Completed Date – Date that Quality
Control (QC) of the abstraction was
completed

Submission Acceptance Date – Date the
trial submission was accepted by a
document specialist who validated it

PDQ Abstraction Completed Date – Date
that PDQ completed the abstraction of the
selected subset of trial attributes

Ready for PDQ Abstraction Date – Initial
date the trial record can be accessed by
PDQ to abstract selected subsets of trial
attributes

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

Submission Rejection Date – Date the trial
submission was rejected by a document
specialist who validated trial submission

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

Table A.1 Descriptions of trial metadata (Continued)

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Ready for QC Date – Date the trial
abstraction was completed so that QC of the
abstraction can be initiated

Initial Abstraction Verified Date – Date the
verification of abstracted data is recorded by
a document specialist who received principal
investigator's or trial submitter's approval on
abstraction

QC Start Date – Date that QC of the
abstraction was initiated

On-going Abstraction Verified Date –
Recordation date for the update on verified
abstraction by the principal investigator/trial
submitter who reviewed the abstraction and
confirmed that trial related data are correct.
OR the date of the verified abstraction
update triggered by specified events and
automatically recorded by the system

NCI DIVISION/PROGRAM CODE
Codes that represent individual NCI divisions and program codes.
CCR – Center for Cancer Research

OD – 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
NCI TRIAL IDENTIFIER
Unique identifier assigned to the trial by the NCI Clinical Trials Reporting Program Trial
Registration Site.
Example: NCI-2010-ABCD
NIH GRANT INFORMATION
NIH grant code. A concatenation of a number of elements.
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.

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

Table A.1 Descriptions of trial metadata (Continued)
68

Appendix A Metadata Definitions

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 identifing a
particular supplemental record.
PRIMARY PURPOSE
Reason for the protocol.
Epidemiologic – Studies among cancer
patients and healthy populations that involve
no intervention or alteration in the status of
the participants, e.g., surveillance, risk
assessment, outcome, environmental, and
behavioral studies.

Observational – Studies in human beings in
which biomedical and/or health outcomes
are assessed in pre-defined groups of
individuals. Subjects in the study may
receive diagnostic, therapeutic, or other
interventions, but the investigator does not
assign specific interventions to the subjects
of the study

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

Outcome – Studies among cancer patients
and healthy populations that involve no
intervention or alteration in the status of the
participants, e.g., surveillance, risk
assessment, outcome, environmental, and
behavioral studies.

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

Ancillary – Auxiliary studies that are
stimulated by, but are not a required part of,
a main clinical trial/study, and that utilize
patient or other resources of the main trial/
study to generate information relevant to it.
Ancillary studies included must be linked to
an active trial or epidemiologic or other study
and should include only patients accrued to
that trial or study. Only studies that can be
linked to individual patient or participant data
should be reported.

Early Detection – Clinical trials directly
testing the efficacy of devices, techniques,
procedures; or tests for earlier detection or
diagnosis of efficacy of devices, techniques,
procedures; or tests for earlier or more
accurate detection or diagnosis of disease.

Correlative – Laboratory based studies
using specimens to assess cancer risk,
clinical outcomes, response to therapies,
etc. Only studies that can be linked to
individual patient or participant data should
be reported.

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.

Table A.1 Descriptions of trial metadata (Continued)

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

Other – Any trial type not defined here.

PRINCIPAL INVESTIGATOR
Investigator responsible for all aspects of the conduct of the study.
Example: Moitessier, Bernard
PROCESSING STATUS
Position of the trial with respect to the abstraction process.
All – Any status.

Abstracted – Trial has been abstracted and
is available for further abstraction.

Submitted – Trial has been submitted but
the abstraction process has not begun.

Abstraction Verified Response – Trial has
been abstracted and completed, and the trial
submitter has responded to the TSR sent for
verification.

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.

RESPONSIBLE PARTY
Either of the following parties:
z

Sponsor of the clinical trial

- or z

Principal investigator of such clinical trial if so designated by a sponsor, grantee,
contractor, or awardee, so long as the principal investigator is responsible for conducting
the trial, has access to and control over the data from the clinical trial, has the right to
publish the results of the trial, and has the ability to meet all of the requirements for the
submission of clinical trial information.
Example: Moitessier, Bernard

SPONSOR
Name of primary organization that oversees implementation of study and is responsible for
data analysis.
Example: Bristol-Myers Squibb
STUDY CLASSIFICATION

Type of primary outcome or endpoint that the protocol is designed to evaluate
Table A.1 Descriptions of trial metadata (Continued)

Appendix A Metadata 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 the
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.

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.
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

SUMMARY 4 SPONSOR/SOURCE
For clinical trials involving an agent or device or other intervention only:
Primary organization responsible for funding the trial.
Example: CTEP
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. The different
phases are as follows:

Table A.1 Descriptions of trial metadata (Continued)

NCI Clinical Trials Reporting Program Registration Site User’s Guide

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

TRIAL STATUS
Code that represents the status of a trial in relation to the ability to enroll participants/patients.
Approved – Trial has been approved

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.

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

Table A.1 Descriptions of trial metadata (Continued)

Appendix A Metadata Definitions

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.

TRIAL TYPE
Nature of the investigation; represents a clinical study by product, procedure, or method
tested.
Interventional – Studies in human beings in
which individuals are assigned by an
investigator based on a protocol to receive
specific interventions. Subjects may receive
diagnostic, therapeutic or other types of
interventions. The assignment of the
intervention may or may not be random. The
individuals are then followed and biomedical
and/or health outcomes are assessed.

Table A.1 Descriptions of trial metadata (Continued)

NCI Clinical Trials Reporting Program Registration Site User’s Guide

APPENDIX

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:
z

Preparing the Trial Data File on this page

Preparing Trial-Related Documents on page 76

Trial Data Element Specifications on page 77

Preparing the Trial Data File
The CTRP website provides a batch upload template, valid data values, data
definitions, examples, and rules for registering batches of trials. This section contains a
summary of the information required for the .xls document. See Using the Batch
Upload Template on page 13.
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:
z

One grant per trial

One IND/IDE per trial

100 trials per file

Interventional trials only

NCI Clinical Trials Reporting Program Registration Site User’s Guide

How to Prepare the Trial Data File
z

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

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 B.1 below.

Figure B.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.
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

Appendix B Batch Upload Data Specifications

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.
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.

Trial Data Element Specifications
The CTRP_Registry_Batch_Upload.xls file lists all trial data required for
registering multiple trials in batches. Trial data specifications include the following:
z

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

Comments

Specifications for proprietary trials

To access the CTRP_Registry_Batch_Upload.xls file, see Downloading Trial
Registration Templates on page 11.
For further details about trial data, refer to Metadata Definitions on page 65.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Appendix C Participating Sites Document Specifications

APPENDIX

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

Participating Sites Document Rules on this page

Participating Site Data Element Specifications on page 80

Participating Sites Document Rules
Participating site documents include treating site and collaborator information.
The CTRP website provides paricipating site document templates, valid data elements,
and rules. See Using the Participating Sites Template on page 12.This section contains
a summary of the participating sites document rules.
Note: Collaborator information is optional.
The following rules apply to participating site documents:
z

Treating site information must include the following:
o

study treating site data

at least one study site investigator's information

treating site contact information

Treating site data includes the following:
o

organization attribute

current recruitment status

status date

target accrual.

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.

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Study site investigator information includes the following:
o

study site investigator data with person's attributes

investigator's role at the study at site

Treating site contact information is optional if an investigator is used as contact
person.

The minimal set of treating site information includes the following:

treating site data

for single investigator studies: study site investigator's information if the
investigator information is used as the site contact information

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

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 11

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.

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

CDRH

Center for Devices and Radiological Health

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

CTWG

Clinical Trials Working Group

NCI Clinical Trials Reporting Program Registration Site User’s Guide

Term

Definition

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.

EBI

European Bioinformatics Institute

EVS

Enterprise Vocabulary Services

FDA

Food and Drug Administration

FDAAA

Food and Drug Administration Amendment Act (2007)

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.

IRB

Institutional Review Board

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

Term

Definition

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

principal
investigator

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

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

section 801 trial

FDA-regulated interventional trial as defined in US Public Law 110-85,
Title VIII, Section 801.

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.

TRP

Translational Research Program (Formerly SPORE)

trial status

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

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

NCI Clinical Trials Reporting Program Registration Site User’s Guide

INDEX
A
accepted trial, defined 81
accounts, creating 8
accrual, defined 81
allocation, defined 65
ancillary trial, defined 17, 69
application support 4
arm, defined 81

CTRO, defined 81
CTRP, defined 81
CTRP templates and resources 11
CTWG, defined 81
current processing status, defined 19
current trial status
categories 35
defined 19

B
basic science, defined 70, 81
batch upload
rules for 50
template for 13

bio-availability study, defined 71
bio-equivalence study, defined 71
browsers, supported 7

C
caDSR, defined 81
CBER, defined 81
CBIIT, defined 81
CBIIT application support 4
CCB, defined 81
CCCT, defined 81
CCR, defined 81
CDE, defined 81
CDER, defined 81
CDP, defined 81
CDRH defined 81
CGH, defined 81
CIP, defined 81
ClinicalTrials.gov registration 23
correlative trial, defined 17, 69
creating accounts 8
credits and resources 3
cross-over intervention model, defined 67
CTAC, defined 81
CTEP, defined 81

data monitoring committee 82
DCB, defined 82
DCCPS, defined 82
DCEG, defined 82
DCP, defined 82
DCTD, defined 82
DEA, defined 82
delayed posting, defined 82
diagnostic trial, defined 69
documents
required 40
required, for batch uploads 49

double blind masking, defined 67
downloading
CTRP registration templates 11
trial-related documents 20

DTP, defined 82

E
early detection trial, defined 17, 69
EBI, defined 82
efficacy study, defined 71
eligibility criteria, defined 82
epidemiologic trial, defined 69
EVS, defined 82
expanded access 38
expanded access states 38
expanded access trial, defined 17
externally peer-reviewed funding, defined 71
85

NCI Clinical Trials Reporting Program Registration Site User’s Guide

F
factorial intervention model, defined 67
FDA, defined 82
FDAAA, defined 82

G
grant codes 32
grantors 37

H
health services research trial, defined 69
holder types 37, 39

I
IDE, defined 82
inclusion/exclusion criteria, defined 82
IND, defined 82
industrial funding category, defined 71
Initial Abstraction Verified Date, defined 68
institute code, defined 66
institutional funding category, defined 71
interventional trial, defined 73
intervention model, defined 66
IRB, defined 82

L
lead organization, defined 19, 66, 82
lead organization trial identifier, defined 19
logging in 10
login 10
editing user information 63

M
masking, defined 67
MedDRA, defined 82
milestones, defined 67

N
N/A, defined 82
national funding category, defined 71
NCI, defined 82
NCICB, defined 82
NCICB application support 4
NCT
defined 82

NCTID, defined 83
NIH divsion/progam codes 33
NIH institute codes 32

non-randomized trial allocation method,
defined 65

O
observational trial, defined 17, 69, 73
OCE, defined 83
OD, defined 83
On-going Abstraction Verified Date, defined 68
open masking, defined 67
OSB/SPOREs, defined 83
outcome trial, defined 17, 69

P
P01, defined 83
parallel intervention model, defined 67
participating site document rules 79
participating sites
document rules 79
template for 12

PDQ, defined 83
PDQ Abstraction Completed Date, defined 67
pharmacodynamics study, defined 71
pharmacokinetics/dynamics study, defined 71
pharmacokinetics study, defined 71
phase, defined 71
PI, defined 83
PIO, defined 83
prevention trial, defined 69
primary purpose
ancillary, defined 69
basic science 70
defined 69
epidemiologic, defined 69
health services research, defined 69
observational, defined 69
outcome, defined 69
prevention, defined 69
screening, defined 70
supportive care, defined 70
treatment, defined 69

principal investigator 70
defined 19, 83
registering new 47
searching for 45

processing status
defined 70
definitions of 18

processing statuses 70
proprietary protocol
documents required for 40

proprietary trials
templates for 12

protocol
data definiitions, resources for 4
specifications for batch uploads 77

protocols

submitting new trials 24
summary 4 categories 30
summary 4 funding category
defined 71
externally peer-reviewed, defined 71
industrial defined 71
institutional, defined 71
national, defined 71

amending 54
submitting 23

purpose, defined 69
purpose values 27

Q
QC, defined 83
QC Completed Date, defined 67
QC Start Date, defined 68

summary 4 sponsor/source, defined 71
supported browsers 7
supportive care trial, defined 70

T
templates

R
R01, defined 83
randomized controlled trial allocation method,
defined 65
Ready for PDQ Abstraction Date, defined 67
Ready for QC Date, defined 68
registering new users 8
rejected trial, defined 83
required documents 40
for batch uploads 49

RRP, defined 83
rules
amendment-specific 56
for batch uploads 50
for participating sties documents 79
for trial status dates 35
trial status dates 35

S
safety/efficacy study, defined 71
safety study, defined 71
screening trial, defined 70
search results
data displayed 19

section 801 trial, defined 83
single blind masking, defined 67
single group intervention model, defined 67
sponsor, defined 83
SPORE, defined 83
status
see also trial status 72
user view criteria 18

study classification, defined 70
Submission Acceptance Date, defined 67
Submission Received Date, defined 67
Submission Rejection Date, defined 67
Submitter Trial Summary Report Feedback
Date, defined 67

downloading 11
for batch uploads 13
for participating sites 12
for proprietary trials 12

templates and resources 11
treatment trial, defined 17, 69
trial ownership 18
trial phase, defined 71
trial phases 26
trial-related documents 20
uploading 41

trials
searching for 15
viewing details 20

trial status
approved, defined 72
closed to accrual, defined 72
closed to accrual and invention, defined 73
complete, defined 73
defined 83
temporarily closed to accrual, defined 72
temporarily closed to accrual and invention,
defined 72

trial status date rules 35
trial summary report 23
see also TSR

Trial Summary Report Sent Date, defined 67
trial type
ancillary, defined 17
basic science, defined 17
correlative, defined 17, 69
defined 73, 83
diagnostic, defined 17, 69
early detection, defined 17, 69
epidemiologic, defined 17
expanded access, defined 17
health services research 17
interventional, defined 73
observational, defined 17, 73
outcome, defined 17
87

NCI Clinical Trials Reporting Program Registration Site User’s Guide

prevention, defined 17
screening, defined 17
supportive care, defined 17
treatment, defined 17

trial validation 18
TRP, defined 83
TSR
content of 54
defined 83
in amendment process 54

U
uploading
batches 49

URI, defined 83
URL, defined 83
user
editing 63

User's Guide, organization of 1
user roles 18

V
validated trial, defined 83
validated trials 18
valid current trial status categories 35
valid expanded access states 38
valid grantors 37
valid holder types 37, 39
valid NIH division/program codes 33
valid NIH grant codes 32
valid NIH institute codes 32
valid purpose values 27
valid summary 4 categories 30
valid trial phases 26
viewing 20
trial-related documents 20

X
XML, defined 83

File Type	application/pdf
File Title	NCI CTRP Registration Site User's Guide v.2.0
Author	Lauren Anthone
File Modified	2009-05-20
File Created	2009-05-20