CTRP Registration Users Guide

Attach_6_CTRP-Registration-UsersGuide.pdf

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

CTRP Registration Users Guide

OMB: 0925-0600

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0600 can be found here:

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1. NCI Clinical Trials Reporting Program (CTRP) User's Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 User's Guides for the CTRP Registration and the CTRP Accrual Web Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 NCI CTRP Registration User's Guide v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1 Contents - NCI CTRP Registration User's Guide v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.1 Getting Started with Registration v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.2 Searching for Trials, Organizations, and Persons in the CTRP System v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.3 Registering New Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.4 Updating Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.5 Amending Complete Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.6 Adding Your Site to Abbreviated Trials v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.7 Registration Site Administration v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.8 Verifying Trial Data v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.9 Working With Persons and Organizations v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.10 Viewing Trial Summary Reports and XML Documents v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.11 Managing Your Account v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.12 Using CTRP Registration Templates v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.13 Viewing Trial-Related Documents v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.14 Working with Tables and Search Results v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.15 CTRP Trial Categories (Study Sources) v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.16 NCI Division and Program Codes v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.17 NIH Institution Codes v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.18 NIH Grant Institute Codes v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.19 Trial Phase Value Definitions v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.20 Trial Processing Statuses v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.21 Trial Registration Funding Mechanism Codes v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.22 Trial Status Date Rules in the CTRP v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.23 Trial Status Transition Rules in the CTRP v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.24 Trial Status Values in the CTRP and ClinicalTrials.gov v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1.1.25 Trial Summary Report and XML File Data Elements v4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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NCI Clinical Trials Reporting Program (CTRP) User's
Guides
NCI Clinical Trials Reporting Program (CTRP) User's Guides
User's Guides for the CTRP Registry and the CTRP Accrual Web Applications
NCI CTRP Registration User's Guide
NCI CTRP Accrual User's Guide

User's Guides for CTRP Web Applications Used Internally
NCI CTRP Protocol Abstraction User's Guide
NCI CTRP Person and Organization Curation User's Guide
NCI CTRP Reports Reference Guides

The CTRP Protocol Abstraction User's Guide, CTRP Person and Organization Curation User's Guide, and CTRP Reports
Reference Guides are designed for internal users. You must be logged in to access these guides.

User's Guides for the CTRP Registration and the CTRP Accrual Web
Applications
User's Guides for the CTRP Registration and the CTRP Accrual Web
Applications
NCI CTRP Registration User's Guide v4.3
NCI CTRP Accrual User's Guide v4.3

NCI CTRP Registration User's Guide v4.3
NCI CTRP Registration User's Guide v4.3
Contents of this Page
About this Guide
Audience
Navigating Registration
Application Support

CTRP Registration
Links
NCI Clinical Trials
Reporting Program
Registration
Overview of NCI CTRP
Applications
Templates for batch
trial and accrual
submissions, and other
resources

CTRP Resources
CTRP Issue Tracker
(JIRA) (Login required)
CTRP Website
Dictionary of cancer
terms
Terminology resources
You can print and export wiki pages
You can send this page to a printer or convert it to a PDF, HTML, or Word document. See Printing and Exporting Wiki Pages.

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

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

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

Navigating Registration
Using the Toolbar
The toolbar runs across the top of each page and remains in place even if you scroll down the page. Menus on the toolbar provide access to
sub-menus whenever an arrow appears next to a menu name. Otherwise, clicking a menu item launches another web page.

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

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

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

How to Display Instructions/Information for a Field
Hover your cursor over the Help icon

next to it.

Online Help provides instruction/information for the topic you are working on.
How to Launch Online Help
Below your name on the toolbar, click Help.

How to access the User's Guide
On the toolbar, click Quick Links > Registration User's Guide.

Changing the Color Scheme
You can choose a site-wide color scheme to suit your preferences.
How to Change the Color Scheme
1. On the top right corner of any page, click (User Name) > My Account.

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

3. Click Save.

Application Support
Email: ncicbiit@mail.nih.gov
Call: 240-276-5541

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

Contacting the Clinical Trials Reporting Office
If you have questions or comments regarding this document, or other CTRP topics, contact the Clinical Trials Reporting Office (CTRO) at ncictro
@mail.nih.gov.

Contents - NCI CTRP Registration User's Guide v4.3
Contents - NCI CTRP Registration User's Guide v4.3

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Getting Started with Registration v4.3
Getting Started with Registration v4.3

Topic Links
About Registration
About Clinical Trial Details
What's New in this Release of
Registration
Typical Life Cycle of a Trial
Role-Based Tasks in Registration
Trial Categories (Study Sources)
Creating CTRP Accounts
Creating New CTRP
Accounts via Email
Creating New CTRP
Accounts Using NIH or NCI
Credentials
Requesting Organization Admin
Rights
Managing Registration Email
Notifications

Tested Browsers
This version of the Registration and
Accrual applications have been tested
on Internet Explorer v10.
This version of the Protocol Abstraction
application and the Person and
Organization Curation application have
been tested on Internet Explorer v10
and the latest version of Firefox.
CTRP should work with all recent browsers.
However, please note that it has been tested
only on the browsers listed. If you discover a
browser related issue in a non-tested browser,
please submit it to Application Support at ncicbii
t@mail.nih.gov. Please include your browser
version, OS version, and, when possible, a
screen shot illustrating the difficulty.
This section introduces you to NCI Clinical Trials Reporting Program (CTRP) Registration, and provides instructions for registering for an account.

About Registration
Registration provides cancer clinical trial access to researchers who have CTRP accounts. It enables these users to register, amend, and update
trials one-at-a-time or in batches consisting of multiple trials, and to view details of existing trials submitted by members of the cancer research
community. You can register Complete and Abbreviated interventional and non-interventional trials.

About Clinical Trial Details

Registration captures clinical trial details, a sanctioned set of key data elements. This set of recorded data enables the research community to
share and analyze standardized clinical trial details.
The glossary on the CTRP web site at http://www.cancer.gov/aboutnci/organization/ccct/ctrp/glossary provides definitions, attributes,
and examples of metadata associated with trials. You can access other CTRP resources from the same page.
As a CTRP account holder, you can search for and review a subset of registered data that has been submitted to CTRP and validated by the
Clinical Trials Reporting Office (CTRO).

What's New in this Release of Registration
This version of the CTRP Trial Registration application has the following new features and improvements:
Issue Type

Development
#

Documentation
#

Description

Link to
Content in this
User's Guide

Comments

Bug

PO-9266

Unable to Submit Amendment for
NCI-2011-02028 in CTRP application

Bug

PO-9198

Re: CTRO#45527: Trial update notification
for NCI-2014-02556

Bug

PO-9182

Add Site in Registry: blank entries followed
by “java.lang.NullPointerException”.

Bug

PO-9116

Major: CCC Wake Forest University
submitter unable to save P30 grant
information (EW#43395)

Improvement PO-9106

Update Study Protocols REST Service to
support additional trial identifiers

Improvement PO-9100

PO-9181

Allow user to specify any organization in
Family as participating site at time of
importing Industrial Trial

Improvement PO-9087

Improve performance of Update Trial
screen in Registry for trials with many sites,
which was hurt significantly by recent
Program Code changes

Improvement PO-9072

PO-9224

Add "NA" as a type for Primary Completion
Date

The only documentation
changes for this issue
were in the PA User's
Guide.

Bug

PO-9055

It shall not open Registry links if account
setup is not done in CTRP

Task

PO-9042

PO-9119

Add Z1A to Funding Mechanism LOV for
PA and Registry

Trial
Registration
Funding
Mechanism
Codes v4.3

Improvement PO-9003

PO-9117

Add TR as a valid value for NIH Institution
Code when adding/editing grants in
Registry and PA

NIH Grant
Institute Codes
v4.3

Also refer to Institute or
Center (IC) section of Glo
ssary of NIH Terms.

Task

PO-8990

Add details to the Registry Users Guide to
show typical lifecycle of trials in CTRP

Typical Life
Cycle of a Trial

Registering
Abbreviated
(Industrial
and Other)
Trials
Using the
Add My
Site
Feature

Bug

PO-8971

Registry User administration privilege
breach

Task

PO-8968

PO-9119

Addition to "Trial Funding" tab in CTRP

Trial
Registration
Funding
Mechanism
Codes v4.3

New Feature

PO-8951

CTRP 4.3 Documentation

(Refer to other
links in this
column.)

Bug

PO-8934

Registry: Registering a trial gives HTTP 500
error if Cancel is selected in Look up
Person

Improvement PO-8815

PO-8955

Restrict updating the Delayed Posting
Indicator to the CTRO staff only

Registering New
Trials v4.3

In Registering New Trials
v4.3, refer to the
Recording Regulatory
Information section.

Improvement PO-8814

Eliminate MailManager in Registry and
refactor to use MailManagerBeanLocal.

Bug

PO-9322

Inconsistent use of terms "Institute" and
"Institution" in GRANT and IND/IDE
sections of PA and Registration UI

Improvement PO-8732

Improve the search performance when the
user searches for trials with a specific
participating site (Registration)

Epic

PO-8330

PO-9053

Improvements to Industrial/Other trials

The only documentation
changes for this issue
were in the PA User's
Guide.

Bug

PO-8028

NCT ID can be imported into CTRP more
than once if import button hit multiple times
quickly

PO-8798

Abstracting
INDs and
IDEs
Abstracting
Funding

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

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

Tasks

User

Site Administrator

Manage Accrual
Access

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

View Accrual
Assignment History

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

Display Trial
Ownership

Yes
For any trial owned by the Administrator's site for which the organization is the lead organization.

Manage Trial
Ownership

Yes

Manage
Participating Site
Record Ownership

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

Grant
Administrative
Authority

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

Request
Administrative
Authority

Yes

Manage
System-Generated
Emails

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

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

Yes

Update/Amend
Trials

Yes

Add/Update
Participating Site
Information

Yes

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Trial Categories (Study Sources)
Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category. Refer to http://cancercenters.cancer.gov/Grant
sFunding/DataGuide#dt4 for further information.
Complete Trials:
National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism
supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems.
Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing
scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center
investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting
results.
It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial
should clearly be the intellectual product of the center investigator.
This category may also include:
Institutional studies authored and implemented by investigators at another Center in which your Center is
participating.
Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and
externally peer-reviewed studies should be listed with those categories, not as Institutional studies.)
Abbreviated Trials:
Industrial/Other: A pharmaceutical company controls the design and implementation of these clinical research studies.
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Creating CTRP Accounts

Although you already have an NIH (or NCI) account, you must register for an associated CTRP account. The CTRP account identifies your
organization affiliation, whether or not you own a particular trial record, and other such details. You can create both types of accounts using
Registration's account creation feature, in one of two ways, as follows:
If you are a new user AND you do not have an NIH/NCI account, request one via Registration. Follow the instructions in Creating New
CTRP Accounts via Email .
If you are a new user AND you have an NIH/NCI account, use your current credentials to register for a CTRP account via Registration.
Follow the instructions in Creating New CTRP Accounts Using NIH or NCI Credentials .
New users must have access to a valid email address to create an account.
Additionally, you can request authorization from the CTRO to use the batch upload feature to register, update, and amend multiple new trials
conducted at a given site. Follow the instructions in Registering Multiple Trials .
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Creating New CTRP Accounts via Email

If you are new to Registration and you do not have an NCI account, request a CTRP account via the Registration account creation feature.
How to Create a New CTRP Account
1. Navigate to the CTRP Registration home page at http://trials.nci.nih.gov/registration.
2. Click the Sign Up tab.

3. In the Email Address field, enter the email address you will use for registering trials (this should be your business email address), and
then click Next.
The Sign Up tab displays the new account form, pre-populated with the email address you provided.

4. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*)
indicates a required field.
Privacy concerns
Contact information is required for internal administrative use only. Your information is not revealed to the public.

Field Label

Description/Instructions

Contact
information*

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

Organization
Affiliation*

Click Look Up and select the appropriate organization from the list of search results. If your trial’s affiliated
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 Looking up Registered Organizations.
Once organization affiliation is established, the system displays one of the following:
If no one in your organization has site administrative (Admin) access, the My Account page displays a
check box that enables you to request Admin privileges.
If at least one other person in your organization currently has a Site Admin role, the system displays the
View Admins link, which enables you to display the name(s) of the current Admin(s).

Request for
Admin
Access

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

PRS
Organization
Name

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

Receive
Email
Notifications

Select this check box if you want the CTRP system to send you an email message whenever some aspect of a trial
you have submitted or own has changed.

Submit

Click to register your information with CTRP. The system sends you an account confirmation email message.

The system sends you a message stating that you will receive an email notification with instructions for activating your account.
Allow two business days for your account to be processed
It may take up to two business days to create your account. If you have any questions in the interim, contact NCI CBIIT
Application Support directly by sending an email to ncicbiit@mail.nih.gov or by calling 888-478-4423.
(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of
Personnel Management's list of Federal Holidays.)
5. Open the account information email when it arrives, and click the embedded link to the My Account page.
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Creating New CTRP Accounts Using NIH or NCI Credentials

How to Create a New CTRP Account Using NIH Credentials
1. Navigate to the CTRP Registration home page at http://trials.nci.nih.gov/registration.
2. Click the Sign Up tab.

3. Because you already have an NIH account, click the here link.
The Sign Up tab displays username and password fields.

4. Enter your username and password, and then click Next.
The My Account Profile page appears, pre-populated automatically with all the information associated with your NIH/NCI account.

5. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*)
indicates a required field.
Privacy concerns
Contact information is required for internal administrative use only. Your information is not revealed to the public.

Field Label

Description/Instructions

Contact
information

Organization
Affiliation

Request for
Admin
Access

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

PRS
Organization
Name

Receive
Email
Notifications

Select this check box if you want the CTRP system to send you an email message whenever some aspect of a trial
you have submitted or own has changed.

Submit

Click to register your information with CTRP. The system sends you an account confirmation email message.

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Requesting Organization Admin Rights
You can request Admin rights for your affiliated organization to take advantage of the following features:
Site Administration - Accept or reject requests for Admin rights from other users within your organization
Trial Ownership management - Assign and unassign ownership of your organization's trials to other registered users within your
organization
Accrual Access - Assign and unassign access to Accrual to registered users within your organization
Condition for Admin Requests
The Request for Admin Access check-box on the My Account page is displayed only if no one else in your organization is an
administrator.
How to Request Admin Rights
1. On the top right corner of any page, click Your Username > My Account.
The My Account page displays all of your Registration account information.
2. Select the Request for Admin Access check box.
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Managing Registration Email Notifications
The Registration system automatically sends you an email message whenever some aspect of a trial you have submitted or own has changed.
For example, the system notifies you when the CTRO has accepted a trial that you submitted. It sends another message when the Trial Summary
Report (TSR) is available for review. You can choose to receive all messages or none of them.
How to Manage Registration Email Messages
1. On the top right corner of any page, click Your Username > My Account.
The My Account page displays all of your Registration account information.
2. To receive all system messages, select the Receive Email Notifications radio button.
3. To opt out, clear the radio button.
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Searching for Trials, Organizations, and Persons in the CTRP System v4.3
Searching for Trials, Organizations, and Persons in the CTRP System v4.3

Topic Links
Searching for Trials
Searching for Organizations
Searching for Persons
Clinical Trial Search Results
Viewing Trial Details
Exporting Search Results

This section provides instructions for searching for trials, organizations, and persons currently registered with the CTRP.
In each case you are presented with a predefined set of search criteria that is appropriate for the type of search you are conducting. This section
also provides instructions for reviewing trial-related documents and downloading Trial Summary Reports (TSRs) and XML documents.

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

Search All Trials

Types of
Trials
Returned

All trials

Actions
Permitted

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

View Trial Details
Add/Update My Site (Abbreviated trials only)
Verify Trials (for trials you submitted but may not
own)
The results of this search may include a
subset of trials that you own or
submitted.

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

Search Saved Drafts
Partial Submissions

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

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

2. Select or enter the appropriate information in the drop-down lists and text fields. (You do not have to select or enter any search criteria if
you use the Search My Trials feature. When searching All Trials, you must select or enter at least one search criterion.) The following
table describes the fields.
Tip
If you are searching for a saved draft, search by Phase, Purpose, or Title only. Because the system adds wildcards for you,
do not enter wildcard symbols in the search fields.
Trial Search Criteria
To search
by this...

Do this...

Title

Enter one or more words from the long title or name of the trial provided by the principal investigator or sponsor.
Avoid copying and pasting, or typing the entire title into the search field
Use keywords rather than phrases or the entire title. Doing so minimizes the potential for excluding from the
search results any titles with misspellings or slightly different phrasing.

Phase

Select the trial phase from the drop-down menu. Valid values are as follows:
0 - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g.,
screening studies, micro dose studies). See FDA guidance on exploratory IND studies for more information.
I - Includes initial studies to determine the metabolism and pharmacologic actions of a medical approach in
humans, the side effects associated with increasing doses or exposure, and to gain early evidence of
effectiveness; may include healthy participants and/or patients.
I/II - Includes trials that are a combination of phases I and II.
II - Includes controlled clinical studies conducted to evaluate the effectiveness of the medical approach for a
particular indication or indications in patients with the disease or condition under study and to determine the
common short-term side effects and risks.
II/III - Trials that are a combination of phases II and III.
III - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of
the medical approach has been obtained, and are intended to gather additional information to evaluate the overall
benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
IV - Studies of FDA-approved drugs, interventions, tests or diagnostic procedures to delineate additional
information including the medical approach risks, benefits, and optimal use.
NA (Not applicable) - All non-interventional or pilot studies.

Pilot Trial?

If the trial is a pilot, select Yes.

Purpose

Select the primary purpose of the trial from the drop-down list. Valid values are as follows:
Treatment. Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or
condition.
Prevention. Protocol is designed to assess one or more interventions aimed at preventing the development of a
specific disease or health condition.
Supportive Care. Protocol is designed to evaluate one or more interventions where the primary intent is to
maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In
general, supportive care interventions are not intended to cure a disease.
Screening. Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a
condition) in people who are not yet known to have the condition (or risk factor).
Diagnostic. Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health
condition.
Health Services Research. Protocol is designed to evaluate the delivery, processes, management, organization,
or financing of health care.
Basic Science. Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics)
of an intervention.
Other. Any purpose not described above.

Identifier
Type

Select the type of trial identifier from the drop-down list. Valid values are as follows:
NCI - NIH National Cancer Institute identifier
ClinicalTrials.gov (ClinicalTrials.gov Identifier) - Provide the exact number, including the ClinicalTrials.gov
Identifier prefix. Example: NCT00012345
Lead Organization - Enter the unique identifier assigned to the trial by the lead organization
Other identifier - Additional trial identifier such as unique identifier from other registries, NIH grant numbers, or
protocol numbers assigned by the Review Board
Selecting a Trial Identifier Type is not required
You can enter an identifier in the Identifier field without first having to choose an Identifier Type.

Identifier

Enter the unique identifier assigned to the trial by the NCI, ClinicalTrials.gov, PRS, or the identifier assigned to it by the
lead organization. For Inter-Group trials, enter the Lead Group's trial number.

Organization
Type

Select one of the following organization roles from the drop-down list:
Lead Organization - Returns all trials on which the selected organization is the Lead Organization
Participating Site - Returns all trials on which the selected organization is a Participating Site
Both - Returns all trials on which the selected organization is either the Lead Organization or Participating Site
You can change the Organization Type without affecting any other search criteria you may have
selected previously.

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

The system suggests names as you type.
Enter the initial letter(s) of the principal investigator's last name and then select the investigator name from the list of
suggestions.

Search by
Trial
Category

To restrict your search by trial category, select Abbreviated or Complete from the drop-down list. Otherwise, select Bot
h.

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

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

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

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

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

6. To view a trial, click its NCI Trial Identifier link.
The Trial Details page appears. See Viewing Trial Details.
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Searching for Organizations
You can search for organizations that are currently registered with the Clinical Trials Reporting Program by any of the following criteria:
Organization Identifying Information
PO ID - Enter the exact PO ID only
CTEP ID - Enter all or part of the CTEP ID
Name - Enter all or part of the Organization's name
Family Name. Enter all or part of the Organization Family's name
Organization Address
Country - Select the country from the drop-down list
City - Enter all or part of the organization's primary location
State - Select the state from the drop-down list
Zip Code - Enter all or part of the Zip code
Organization Type. Select one of the following:
Lead Organization - Returns organizations that are Lead Organizations
Participating Site - Returns organizations that are Participating Sites
Both - Returns organizations that are either Lead Organizations or Participating Sites
You can use this search feature to identify organizations when you use the batch upload template to register multiple trials
simultaneously.
How to Search for Registered Organizations
1. Click the Search Organizations tab. Or, on the toolbar, click Search > Organizations.

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

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

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

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

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Searching for Persons
You can search for persons that are currently registered with the Clinical Trials Reporting Program.
You can use this search feature to identify persons when you use the batch upload template to register multiple trials simultaneously.
How to Search for Registered Persons
1. Click the Search Persons tab. Or, on the toolbar, click Search > Persons.

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

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

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

6. To view the details of the organization with which the person is affiliated, click its PO-ID link.
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Clinical Trial Search Results
The Clinical Trials Reporting Office (CTRO) reviews each trial submitted to the system in order to validate submitted information. During the
validation process, the reviewers check for duplicate records and ensure that the submitter has provided all required information. CTRO does one
of the following as part of the validation/abstraction process:
If all data is complete and accurate, the reviewers assign the trial the status "Accepted," and the system notifies the submitter by email.
If information is missing, or there are discrepancies in the information provided, the reviewers can place a trial on hold. The CTRO
contacts the submitter for clarification and/or to request missing documents, and resumes processing once the trial is validated.
If the trial is a duplicate (i.e., another user has submitted the same trial), the reviewers assign the trial the status "Rejected," and the
system sends the submitter an email message indicating the status and reason for the rejection. Reviewers may also reject a trial if
CTEP/DCP/CCR has approved the trial. NCI transfers these trials internally.
If you have questions about a rejected trial, contact the CTRO at ncictro@mail.nih.gov.
The trials that match your search criteria are listed in search results tables. Which of the search results are displayed is determined by the
following criteria:
Processing status of the trial at the time of the search. Trial statuses are listed and defined in Trial Processing Statuses.
Submitted - Original trial submitted but not validated
Amendment Submitted - Amendment submitted but not validated
Accepted - Trial passed validation
Rejected - Trial did not pass validation. These trials are not displayed.
Abstracted - Trial has been abstracted
Verification Pending - Trial has been abstracted, and the Trial Summary Report (TSR) has been sent to the trial submitter for
abstraction verification
Abstraction Verified Response - Submitter has verified the abstraction as per the TSR, and has returned feedback to the
CTRO within five business days after receiving the TSR

Abstraction Verified No Response - Submitter has not responded or returned verification feedback to the CTRO within five
business days after receiving the TSR
User's role with respect to the trial. User roles include the following:
Site Administrator - Has full access to the trials led by the organization (plays lead organization role)
Trial Submitter/Owner - Has full access to the trials they own or submitted
Other user - Any user other than the trial submitter, owner, or trial's lead organization system administrator
Trial ownership. Trial ownership types are as follows:
Private trials - Trials submitted or owned by the user who is currently logged in to Registration
Public trials - Trials submitted by other registered users
(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's
list of Federal Holidays.)

To navigate the search results table, see Working with Tables and Search Results.
Trial records returned from "Search My Trials" and "Search All Trials" options display the following details and actions you can take for each trial
when applicable.
No data are displayed for Private trials with a processing status of Rejected nor for Public trials with a processing status of Submitted or
Rejected.
The following table describes the columns in the search results table:
Column

Displayed
for Public
trials?

Description

NCI Trial
Identifier

Yes

Unique identifier assigned to the trial by the CTRP

Title

Yes

Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol
document)

Lead
Organization

Yes

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

Lead Org
(Organization)
Trial Identifier

Yes

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

Principal
Investigator

Yes

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

ClinicalTrials.gov
Identifier

Yes

Number assigned to the trial by PRS (ClinicalTrials.gov) (for trials that have been submitted to
ClinicalTrials.gov previously)

Other Identifiers

Yes

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

Current Trial
Status

Yes

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

Current (Trial)
Processing
Status

Stage in the trial processing work flow

Available
Actions

Yes

Actions that are applicable to the trial according to the processing rules
Update - Link used to initiate trial updates
Amend - Link used to initiate trial amendments. Available for trials with processing statuses abstraction
verified (response/no response).
Change Status - Link used to initiate a change to the trial status and status dates
Add My Site - Link used to initiate adding an organization as a participating site
Update My Site - Link available to Participating Site Record owners to initiate participating site
information changes
Request TSR and XML documents (for complete trials) - Documents are sent via email to all trial owners
Verify Trial Data - Link used to verify open trial records twice per year to ensure that information is
accurate and up-to-date
The actions available for a trial depend on its processing status and participating site record
ownership.

Accrual Disease
Terminology

The disease terminology currently in use for accruals. You can select a new terminology from the drop-down
list only if the trial has not accrued patients. Additionally, you can change accrual disease terminology at any
time for trials currently recording accruals at the summary level only.

(Participating)
Sites

Yes

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

Phase

Phase of the investigation, as defined by the US FDA for trials involving investigational new drug

Primary Purpose

Main purpose of the trial

Category

Data Table 4 Funding Sponsorship or Trial Submission Category

Trial Start Date

Date on which the trial starts

Responsible
Party

Responsible party, as defined by FDAAA

Sponsor

Primary organization that oversees the implementation of the study and is responsible for data analysis as
defined in 21 CFR 50.3

Data Table 4
Funding
Sponsor Type

Trial category selected for trial submission

Record
Verification Date

Date on which the CTRO validated the trial submission

Submitter

Name of person who submitted the trial

Primary
Completion Date

Date on which the trial reaches/reached its primary completion date

Last Update
Submitted

Date on which the trial was last updated

Last Updater
Name

Name of the person who last updated the trial

Last
Amendment
Submitted

Date on which the trial was last amended

Last Amender
Name

Name of person who amended the trial

On-Hold Reason

Reason why the trial was placed on hold

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

Description

Temporary Trial
Identifier

Unique identifier that the system assigned to the saved draft

Title

Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol
document)

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 sponsoring organization. Multiple studies conducted under the
same grant must each have a unique number

Action

Complete - Link to initiate trial record completion
Delete - Link to initiate trial deletion

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

Trials you search for are listed in the Submitted Clinical Trials Search Results table as shown below.

To view details for a given clinical trial listed on a search results page, click its associated NCI Trial Identifier hypertext link.
The details provided for a given trial depend on trial ownership (private or public) and Data Table 4 Category (Complete or Abbreviated).
The Trial Details page displays the metadata as entered by a trial submitter. The upper part of the Trial Details page is shown below. Refer to the
Glossary of CTRP Terms for a description of the metadata.

Responsible party, IND/IDE, NIH grant information and trial-related documents are only displayed for Private trials.
To return to the Search Trials page, scroll to the bottom of the Trial Details page, and click Back to Search Results.

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Exporting Search Results

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

2. At the bottom left corner of the Search Results page, next to Export Options, click one of the following links:
CSV - Exports comma-separated values to a resultsTrialSearch.csv file
Excel - Exports Excel-formatted data to a resultsTrialSearch.xsl file
A download pop-up dialog box appears.
3. Follow your browser/operating system instructions to view or save the document.
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Registering New Trials v4.3
Registering New Trials v4.3

Topic Links
About Trial Registration
Guidelines for Complete
Trials
Guidelines for Abbreviated
Trials
Guidelines for
Trials with NCT
IDs
Guideline for
Trials without NCT
IDs
Registering New Complete Trials
Recording Trial
Identification Information
Recording Interventional
Trial Details
Recording
Non-Interventional Trial
Details
Recording Lead
Organizations and
Principal Investigators
Recording Sponsors and
Responsible Parties
Recording Data Table 4
Information
Recording NIH Grants
Recording Trial Statuses
Trial Status
Transitions
Recording Trial Dates
Start, Primary
Completion, and
Completion Date
Rules
Recording INDs and IDEs
Recording Regulatory
Information
Recording Trial-Related
Documents
Converting
Documents to
PDFs
Registering Multiple Complete
Trials in Batch Files
Preparing Data Files
Trial
Requirements
Data File
Requirements
Template
Requirements
Preparing Trial Document
ZIP Files
Submitting Trial Document
ZIP Files
Registering Abbreviated (Industrial
and Other) Trials
Printing Trial Information
Editing Trial Details
Completing and Deleting Saved
Drafts

This section describes how to register new National, Externally Peer-Reviewed and Institutional trials (collectively referred to as Complete trials) in
the CTRP system, and how to import Industrial trials from ClinicalTrials.gov for registration in the CTRP. It applies to both interventional and
non-interventional trials.

Gather all the protocol data you need before you begin
The system logs you off if it detects that you have not used the application for 90 minutes.

The system locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your
account, contact CBIIT Application Support at ncicbiit@mail.nih.gov , or phone: 240-276-5541 or toll free: 888-478-4423. If you have
forgotten your password, see Resetting Your NCI Password .

About Trial Registration
The way in which you register trials in the CTRP depends on a combination of the trial's Data Table 4 Categorization as either Complete or Abbre
viated , your affiliated organization and its role in the trial, and whether the trial currently is registered in ClinicalTrials.gov with an NCT ID.
Guidelines for Complete Trials

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

Guidelines for Abbreviated Trials

If your trial is Abbreviated, registration differs according to a combination of the following trial attributes:
NCT ID (which indicates that the trial has been registered with ClinicalTrials.gov)
Cancer center type (NCI-designated Cancer Centers or other centers)
NCI grant
Lead organization
Guidelines for Trials with NCT IDs

If the trial is an Industry funded trial, and has an NCT ID, then it can be imported into CTRP from ClinicalTrials.gov in most cases. In some special
cases, however, the trial cannot be imported directly and instead you must contact the CTRO for assistance.
If your organization is not an NCI-designated Cancer Center, NIH institute, or pharmaceutical company, you will need to import the trial
directly from ClinicalTrials.gov. Instructions for this process can be found under Registering Abbreviated (Industrial and Other) Trials.
The system assigns the trial you import from ClinicalTrials.gov the Data Table 4 Category (funding source) Industrial/Other. To specify
whether the trial is Industrial, or to specify if an Other trial is National or Externally Peer-Reviewed, contact the CTRO for assistance at
ncictro@mail.nih.gov. For funding source definitions, see http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4.
If your organization is the Lead Organization on a trial, and your organization is an NCI-designated Cancer Center, do not import the trial
from ClinicalTrials.gov. Instead, submit the trial to CTRP as a Complete trial, as described in Registering New Complete Trials.
If your organization is the Lead Organization for any trial on anything other than an NCI-designated Cancer Center, NIH institute, or
pharmaceutical company trial, the CTRO contacts the Center and further categorizes the trial as Other/National or Other/Externally
Peer-Reviewed based on whether your trial is conducted under an NIH grant, as follows:
If your trial is conducted under an NCI grant, the CTRO categorizes it as a Consortia trial.
If your trial is not conducted under an NCI grant, the CTRO categorizes it as follows:
Other/National, for trials sponsored by an NIH institute
Other/Externally Peer-Reviewed, for trials managed by a hospital or a center other than one designated by the NCI
Guideline for Trials without NCT IDs

If your trial is Abbreviated but does not have an NCT ID, please contact the CTRO for assistance at ncictro@mail.nih.gov. CTRO registers these
trials manually.

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Registering New Complete Trials

Before you begin to register a trial, ensure that the trial does not exist in the system already by searching for trials using any of the
criteria as per the instructions in Searching for Trials . The system uses the Lead Organization ID, Lead Organization Trial ID, and the
ClinicalTrials.gov Identifier to detect duplicates. If a duplicate is detected, the system will not record your trial.
How to Register New Complete Trials
1. On the toolbar, click Register Trial, and select your trial's Submission Category (funding source) from the drop-down list, either National,
Externally Peer-Reviewed, or Institutional.
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, click the
Help icon (

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

The Register Trial page appears.

The system can create an XML document that is formatted to facilitate trial registration with ClinicalTrials.gov. The document it creates
contains all the information that you submit during registration and all the trial data abstracted by the CTRO. If you indicate that you do
not need to register the trial with ClinicalTrials.gov, you will not be asked to provide regulatory and responsible party information.
You can expand and collapse sections of the registration page
By default, all sections of the registration form are displayed.
To collapse or expand each section individually, click the Collapse or Expand icon on the right side of the section title as
shown in the figures below.
To collapse all sections, click Collapse All.

2. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.
Tip
Be sure to provide information for all fields marked with an asterisk (*). If you cannot complete the registration of a trial in one
Registration session, you can save a draft of the trial details you have completed. Later you can return to complete the
registration in another session.

Instructions for registering Complete trials

XML required. Enable
"Upload from NCI CTRP"
in ClinicalTrials.gov?

If you require an XML document to register your trial with ClinicalTrials.gov, select Yes.
If you are not going to submit your trial to ClinicalTrials.gov, select No.
The option you select here dictates which sections you will be required to complete. For example, if you
select No, you will not be required to complete responsible party and regulatory information. If you select
Yes, NCI will be added as a collaborator to the Funding Source.

Various

Select or enter the appropriate information in the text fields and drop-down lists as appropriate according
to the detailed instructions provided for each of the following sections:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.

Recording Trial Identification Information
Recording Interventional Trial Details
Recording Non-interventional Trial Details
Recording Lead Organizations and Principal Investigators
Recording Sponsors and Responsible Parties
Recording Data Table 4 Information
Recording NIH Grants
Recording Trial Statuses
Recording Trial Dates
Recording INDs and IDEs
Recording Regulatory Information
Recording Trial-Related Documents

Save as Draft

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

Review Trial

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

Cancel

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

3. Correct any errors if indicated, and repeat the previous steps as many times as necessary until the trial is error-free.
4. To continue with the trial registration, scroll to the bottom of the Review Trial Details page, and then click Submit. To prevent creating a
duplicate record, do not click Submit more than once. If you have to make changes after you click Submit, contact the CTRO at ncictro
@mail.nih.gov rather than using your browser's Back button to make changes.
The registration notification message system sends you an email message to acknowledge that the trial has been submitted. Later it
sends another email message to notify you when your trial has been accepted or rejected.
After submission, most users other than the trial submitter can not see the trial information you provided until the information has been
validated. However, an organization administrator (if one exists) and an assigned owner can access the information prior to validation.
Return to top of page
Recording Trial Identification Information

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

How to Complete the Trial Identifiers Section
1. Indicate whether or not you require an XML document for registration with ClinicalTrials.gov. The default is Yes. If you select No, you will
not be asked to provide regulatory and responsible party information.
2. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*)
indicates a required field.
Instructions for recording Trial Identifiers for Complete trials
Field Label

Description/Instructions

Lead
Organization
Trial Identifier*

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

ClinicalTrials.gov
Identifier

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

You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make
changes thereafter, contact the CTRO at NCICTRO@mail.nih.gov.

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

Other Trial
Identifier

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

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Recording Interventional Trial Details

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

Description/Instructions

Title*

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

Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list
provides valid values.

Phase*

0 - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g.,
screening studies, micro dose studies). See FDA guidance on exploratory IND studies for more information.
I - Includes initial studies to determine the metabolism and pharmacologic actions of a medical approach in
humans, the side effects associated with increasing doses or exposure, and to gain early evidence of
effectiveness; may include healthy participants and/or patients.
I/II - Includes trials that are a combination of phases I and II.
II - Includes controlled clinical studies conducted to evaluate the effectiveness of the medical approach for a
particular indication or indications in patients with the disease or condition under study and to determine the
common short-term side effects and risks.
II/III - Trials that are a combination of phases II and III.
III - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of
the medical approach has been obtained, and are intended to gather additional information to evaluate the overall
benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
IV - Studies of FDA-approved drugs, interventions, tests or diagnostic procedures to delineate additional
information including the medical approach risks, benefits, and optimal use.
NA (Not applicable) - All non-interventional or pilot studies.
Is this a Pilot?*

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

This field is
displayed
only if you
selected NA
from the Ph
ase drop-do
wn list.
Trial Type*

Select the trial type indicated in the protocol. Interventional is the default.

Primary Purpose*

1. Select the primary reason for conducting the trial. The following list provides valid values.
Treatment. Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or
condition.
Prevention. Protocol is designed to assess one or more interventions aimed at preventing the development of a
specific disease or health condition.
Supportive Care. Protocol is designed to evaluate one or more interventions where the primary intent is to
maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In
general, supportive care interventions are not intended to cure a disease.
Screening. Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a
condition) in people who are not yet known to have the condition (or risk factor).
Diagnostic. Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health
condition.
Health Services Research. Protocol is designed to evaluate the delivery, processes, management, organization,
or financing of health care.
Basic Science. Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics)
of an intervention.
Other. Any purpose not described above.
2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.
The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts
down the character numbers as you type.

Secondary Purpose

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

Accrual Disease
Terminology*

Click to select the disease terminology used to report subject accruals for this trial.

Return to top of page
Recording Non-Interventional Trial Details

How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section
are required.
Instructions for recording Trial Details
Field Label

Description/Instructions

Title*

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

Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list
provides valid values.

Phase*

Select N/A for observational and ancillary-correlative trials.
0 - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g.,
screening studies, micro dose studies). See FDA guidance on exploratory IND studies for more information.
I - Includes initial studies to determine the metabolism and pharmacologic actions of a medical approach in
humans, the side effects associated with increasing doses or exposure, and to gain early evidence of
effectiveness; may include healthy participants and/or patients.
I/II - Includes trials that are a combination of phases I and II.
II - Includes controlled clinical studies conducted to evaluate the effectiveness of the medical approach for a
particular indication or indications in patients with the disease or condition under study and to determine the
common short-term side effects and risks.
II/III - Trials that are a combination of phases II and III.
III - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the
medical approach has been obtained, and are intended to gather additional information to evaluate the overall
benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
IV - Studies of FDA-approved drugs, interventions, tests or diagnostic procedures to delineate additional
information including the medical approach risks, benefits, and optimal use.
NA (Not applicable) - All non-interventional or pilot studies.
Is this a Pilot?*

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

This field is
displayed
only if you
selected N
A from the
Phase dro
p-down list.
Trial Type*

Select the trial type. Non-Interventional is selected by default.

Non-Interventional
Trial Type*

Select one of the following trial types:
Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration
of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The
participants in the study may receive diagnostic, therapeutic, or other interventions but the investigator of the
observational study is not responsible for assigning specific interventions to the participants of the study.
Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship
between a condition and a potential causal factor of the condition.
Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that
utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies
must be linked to an active clinical research study and should include only patients accrued to that clinical
research study. Report only those studies that can be linked to individual patient or participant data.
Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to
therapies, etc. Report only those studies that can be linked to individual patient or participant data.

Primary Purpose*

1. Select the primary reason for conducting the trial. The following list provides valid values.
Treatment. Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or
condition.
Prevention. Protocol is designed to assess one or more interventions aimed at preventing the development of a
specific disease or health condition.
Supportive Care. Protocol is designed to evaluate one or more interventions where the primary intent is to
maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general,
supportive care interventions are not intended to cure a disease.
Screening. Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a
condition) in people who are not yet known to have the condition (or risk factor).
Diagnostic. Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health
condition.
Health Services Research. Protocol is designed to evaluate the delivery, processes, management, organization,
or financing of health care.
Basic Science. Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics)
of an intervention.
Other. Any purpose not described above.
2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you
selected earlier, either Observational or Ancillary -Correlative , in the text field.
The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts
down the character numbers as you type.

Study Model Code*

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

Time Perspective
Code*

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

Site Principal
Investigator*

Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .

Return to top of page
Recording Lead Organizations and Principal Investigators

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

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

2. Select the appropriate organization from the list. If the organization is not listed, click Search, and search for the organization as per the
instructions in Looking up Registered Organizations .
a. If the search does not return your trial's lead organization, you can register it in the system at this point. To register an
organization, follow the instructions in Adding Organizations to the CTRP.
3. Next to Principal Investigator click Look Up Person, and search for the principal investigator as per the instructions in Looking Up
Registered Persons.
a. If your trial's principal investigator's name is not listed, you can register it in the system at this point. To register an investigator,
follow the instructions in Adding Persons to the CTRP.
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Recording Sponsors and Responsible Parties

Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
The system will not display this section unless you indicate that you require an XML document.
The Responsible Party can be either a sponsor, principal investigator (PI), or sponsor/investigator. The term "responsible party" is either of the
following:
1. Sponsor. Name of the primary organization that oversees the implementation of the study and is responsible for data analysis. For
applicable clinical trials, sponsor is defined in 21 CFR 50.3.
- or 2. Principal Investigator. The individual who serves as the principal investigator and is designated as responsible party, consistent with the
conditions described in the statute.
- or 3. Sponsor-Investigator: The individual who both initiates and conducts the study.
For further elaboration on the definition of these roles with respect to responsible party, see http://prsinfo.clinicaltrials.gov/Elaborations
OnDefinitions.pdf.

You must complete all fields in the Sponsor/Responsible Party section. The fields displayed depend on your selection of the Responsible Party
role, as shown in the images below.

If you select Sponsor (above), you do not submit any further information about the Responsible Party.

If you select Principal Investigator (above), this section expands to display the investigator's title and organization affiliation. The system
populates the Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator
section.

If you select Sponsor-Investigator (above), this section expands to display the investigator's title and organization affiliation. Although the system
populates the Investigator's name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator
section, you can select another person for this role.
Before you begin, complete the Lead Organization/Principal Investigator section. Doing so will ensure that the Sponsor/Responsible
party section is pre-populated when applicable.
How to Complete the Sponsor/Responsible Party Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section
are required.
Field Label

Description/Instructions

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

Responsible
Party*

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

Investigator*

If the Responsible Party is the Principal Investigator, you can not change the person's name.
If the Responsible Party is the Sponsor-Investigator, you can change the person's name. To do so, click Look Up Sponsor,
and follow the instructions in Looking Up Registered Persons .

Investigator
Title*

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

Investigator
Affiliation*

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

Return to top of page
Recording Data Table 4 Information

Complete all fields in the Data Table 4 Information section. The Trial Submission Category (study source) or Data Table 4 Funding Sponsor Type
fields are pre-populated with the sponsor type.
The lead organization or at least one participating site must be an NCI-designated cancer center.
How to Complete the Data Table 4 Information Section
1. Hover your mouse over Please Select the Data Table 4 Sponsor Organization. A list of organizations appears.
2. Select the name of the external sponsor or funding source as defined by the Data Table 4 report. See Looking Up Registered
Organizations. (If your trial's funding sponsor is not listed, you can register it in the system at this point. To register an organization, see A
dding Organizations to the CTRP.)

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

A trial can have multiple sponsors. Repeat the steps above to add other sponsors. The system ensures that you don't duplicate
an existing sponsor.
3. To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
4. In the Program Code field, enter the code that includes the study.
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Recording NIH Grants

This section pertains to Complete trials. You must record NIH grant information for your trial, including the funding mechanism, institute code,
serial number, and NCI division/program. You can add up to five NIH grants.
If the Lead Organization for the trial is a member of an NCI-Designated Cancer Center, you must record a valid P30 grant.
For a complete guide to NIH grant information, see the Grants and Funding page at http://grants.nih.gov/grants/funding/funding_program.htm.

How to Complete the NIH Grant Information Section
1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this

1.
section are required if your study is funded by NIH.
Instructions for recording NIH Grant Information
Field Label

Description/Instructions

Is this trial
funded by an NCI
grant?

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

Funding
Mechanism

Enter the initial letter(s) and or number(s) in the Funding Mechanism field and then select the NIH unique identifier from the dropactivity applied to funding mechanisms.

Tip
Click the down arrow in the field, and then use the up and down arrow keys on your keyboard to scroll up and down the d
For a list of valid codes, see Funding Mechanism Codes.
Institute Code

Select the two-letter code identifying the first major-level subdivision, the organization that supports an NIH grant, contract, or inte
For a list of valid codes, see NIH Grant Institute Codes .

Serial Number

Enter the five- or six-digit number generally assigned sequentially to a series within an Institute, Center, or Division, for example,
match the sequence of serial numbers as you type them one-by-one. By selecting a grant from the list, you ensure that you record

NCI
Division/Program
Code

Enter the initial letter(s) of the division or program code, and then select the code for the organizational unit that provides funding
For a list of Division and Program codes, see NCI Division and Program Codes .

2. Click Add Grant.
The Add button is operable only after you have provided the grant information in all fields.
The grant is displayed and added to the trial, and the Grant fields are reset.
3. If your trial is funded by more than one grant, repeat the steps above, and then click Add Grant.
4. To delete a grant record from a trial, in the Action column, click Delete.
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Recording Trial Statuses

Trial status refers to the current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants/patients.
Valid trials used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial
Status Values in the CTRP and ClinicalTrials.gov.
Errors and Warnings
The system validates each new status as you add it, as well as when you review the trial information before submitting the trial for
registration.

If you add a status that does not conform to the rules provided in Trial Status Transitions , the system displays errors and/or warnings. Warnings i
ndicate that fixing the record is optional. However, Errors indicate that you must correct an invalid transition in order to submit the trial for
registration.
If you register a trial after it has reached the status Active or Closed to Accrual, you must create a complete Trial Status History by adding all
previous statuses in order, as per the rules provided in Trial Status Transitions.
How to Complete the Trial Status Section

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

Description/Instructions

Trial
Status
Date*

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

Trial
Status

Select the trial’s accrual status from the drop-down list. Valid values are as follows:
In Review - Trial is currently under IRB review.
Withdrawn - Trial has been withdrawn from development and review prior to enrollment of the first participant.
Approved - Trial has been approved, but is not yet recruiting or enrolling participants.
Active - Trial is open for accrual and enrollment.
Enrolling by Invitation - Participants are being (or will be) selected from a predetermined population.
Temporarily Closed to Accrual - Participant recruitment or enrollment has been halted prematurely but may resume.
Participants already on trial continue to receive intervention.
Temporarily Closed to Accrual and Intervention - Participant recruitment or enrollment has been halted prematurely
but may resume. Participants already on trial do not receive intervention.
Closed to Accrual - Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to
receive treatment and/or examination).
Closed to Accrual and Intervention - Trial has been closed to participant accrual. Participants already on trial do not
receive treatment, but continue to be monitored for endpoints such as long-term survival.
Administratively Complete - Participant recruitment or enrollment has been halted prematurely (for example, due to
poor accrual, insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the trial do not
receive further treatment or examination.
Complete - Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and
participants are no longer monitored for trial endpoints (i.e., last patient's visit has occurred). The trial has met its
objectives.

Why
Study
Stopped

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

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

3. If the system indicates that the status you added is invalid, do one of the following.
To edit the status, in the Actions column, click the Edit icon and make changes as indicated in the Error and/or Warning
message.

To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the
record, and then add the correct status information.
If a Complete trial reaches any of the statuses below, the system closes the trial at all participating sites, and sets their trial
statuses to match those of the trial that closed.
Closed to Accrual
Closed to Accrual and Intervention
Administratively Complete
Complete

The system displays the following warning if you enter any of the statuses above:

Trial Status Transitions

The table and diagram below provide rules for ensuring that you record valid transitions between trial statuses.
Trial Status Flow Relationships
A trial can proceed from this
status…
In Review

Directly to this status

Approved
Withdrawn

Or to this status

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

Approved

Active/Enrolling by
Invitation
Withdrawn

Active/Enrolling by Invitation

Closed to Accrual

Closed to Accrual and
Intervention

Completed
Administratively
Completed

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

Temporarily Closed to Accrual

Temporarily Closed to Accrual
and Intervention

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

Temporarily Closed to Accrual
and Intervention

Administratively Completed

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

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

Trial Status Transitions
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Recording Trial Dates

The Trial Dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Start, Primary
Completion, and Completion Date Rules.

How to Complete the Trial Dates Section
1. Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field.
2. Indicate whether the dates you entered are Actual or Anticipated.
Valid trials used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial
Status Values in the CTRP and ClinicalTrials.gov.
Start, Primary Completion, and Completion Date Rules

Valid dates for a given trial status depend on the other values you have entered, and whether those dates are Actual (current, or past) or Anticipat
ed (future).
The following diagram illustrates these rules. The arrow at the top of the diagram represents a time line for the life of a trial. The three horizontal
bands in the lower section of the diagram represent, from top to bottom, the relative date (actual or anticipated) rules for trial Start Date types,
Primary Completion Date types, and Completion Date types.

The following table provides the rules for trial status dates as diagrammed.
Rules for Status/Dates relationships
If this is true...

Follow this rule

Current Trial Status is anything other than In Review, Approved, or
Withdrawn

Trial Start Date must be Actual (solid band)

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated (diagonal stripes
band)

Current Trial Status is Complete

All date types must be Actual (solid band)

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

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Recording INDs and IDEs

Enter the IND/IDE number and grantor fields only if your trial is/was conducted in the United States. You must indicate whether your trial qualifies
as an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.
There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.

How to Register IND/IDE Trials
1. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.
Instructions for recording IND/IDE Information
Field Label

Description/Instructions

IND/IDE Types*

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

IND/IDE Number*

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

IND/IDE Grantor*

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

IND/IDE Holder Type*

Select one of the following holder types:
1.
2.
3.
4.
5.

Investigator
Organization
Industry
NIH
NCI

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

Select a code from the drop-down list.
If you selected NIH from the IND/IDE Holder Type list, see NIH Institution Codes f
or valid values.
If you selected NCI from the IND/IDE Holder Type list, see NCI Division/Program
Codes for valid values.

Expanded Access?

If an experimental drug or device is available outside any clinical trial protocol, select Y
es.

Expanded Access Type* (required if you selected
the Yes check box in the Expanded Access? colum
n)

Select one of the following access types:

Exempt?

Select the Yes check box in the Exempt? column if the investigational product does
not require FDA approval .

1. Available - Expanded access is currently available for this treatment
2. No Longer Available - Expanded access was available for this treatment
previously but is not currently available and will not be available in the future
3. Temporarily not available - Expanded access is not currently available for this
treatment, but is expected to be available in the future
4. Approved for Marketing - This treatment has been approved for sale to the
public

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

Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
The system will not display this section if you indicated that you do not require an XML document for ClinicalTrials.gov.

How to Complete the Regulatory Information Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a
required field. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fields.
Instructions for recording regulatory information
Field Label

Description/Instructions

Trial Oversight
Authority Country*

Select the name of the country in which the oversight authority organization is located.
After you make your selection, the oversight authorities registered in the country you selected are listed in the Trial
Oversight Authority Organization Name field.

Trial Oversight
Authority
Organization Name*

Select the name of the organization that oversees the trial from the drop-down list.

FDA Regulated
Intervention
Indicator*

Indicate whether the trial is regulated by the FDA by selecting Yes or No.

Section 801
Indicator*

For interventional trials, indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US
Public Law 110-85, Title VIII, Section 801 by selecting Yes or No.

You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE.
If the trial is interventional and you indicated that it is regulated by the FDA, the Regulatory Information
section displays fields for Section 801. You are required to complete these fields.

If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes
available and defaults to No. This field is read-only. You may request a change in its value by submitting a
request to the CTRO at ncictro@mail.nih.gov.
Delayed Posting
Indicator*

This indicator becomes available only when you indicate that the trial is applicable under Section 801. Only the CTRO
can modify this indicator’s value:
A No value indicates that any devices in the trial have already been approved or cleared by the US FDA, and so
there is no need to delay posting of trial information information on ClinicalTrials.gov.
A Yes value indicates that the release of trial information on ClinicalTrials.gov is being delayed until after an
interventional device has been approved or cleared.
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov.

Data Monitoring
Committee
Appointed Indicator

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

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Recording Trial-Related Documents

When registering Complete trials, you must upload the following types of documents:
1. Complete clean Protocol document
2. IRB Approval
3. List of Participating Sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact
information.
4. Informed Consent (if not included in the protocol document)
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. Use the .xls format for template files.
Special processing for PDF files
Adobe PDF files require special processing. See the information about creating PDFs in Converting Documents to PDFs .

How to Submit Trial Related Documents
1. Next to the document-type field, (e.g., Protocol Document), click Browse.
2. Navigate to, and select, the appropriate document, and then click Open.
Depending on your operating system, you may see a different command name for "Open."
3. Repeat the steps above for each type of document.
Adding Multiple "Other" Documents
You can upload more than one (1) "Other" document. After you have uploaded the first of your "Other" documents, click the Ad
d More link. A new Other document field is displayed.
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Converting Documents to PDFs

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

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

and in the Help documentation in each of its applications.

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

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

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

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Registering Multiple Complete Trials in Batch Files
You can submit multiple trials for registration by recording trial data in pre-formatted Excel spreadsheets called batch templates. There are
separate templates for Complete trial information and participating sites.
As an authorized CTRP submitter you can use the CTRP batch upload feature to register multiple new Complete trials that were conducted at a
given site, and to update and/or amend them as necessary. The batch upload template, a predefined Excel spreadsheet, provides the structure
for recording your trial data. When you have recorded the data and have prepared trial-related documents, upload them for submission using the
CTRP batch upload feature. CTRO staffs use the information you provide in these documents to register your trials.
Before You Begin
Request authorization from the CTRP to upload batches. Send your request via email to the CTRO. Once you have received approval,
you do not have to request approval for subsequent uploads.
Upload each of the following types of files whenever you register multiple trials:
1. Data documents – Documents that contain all the requisite information about the trial.
2. Trial-related documents – Protocol and IRB documents, among others. You are not required to upload these types of documents when
updating registered trial records.
Main Steps for Uploading Your Complete Trial Data
1. Prepare the trial data file. See Preparing Batch Data Files.
2. Prepare the trial documents Zip file. See Preparing Trial Document ZIP Files.
3. Upload your files to the CTRP system via the NCI Trial Registration batch upload web page at https://trials.nci.nih.gov/registry/admin/batc
hUpload.action. See Submitting Trial Document Zip Files.
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Preparing Data Files

The CTRP website provides a batch upload template, valid data values, data definitions, examples, and rules for registering batches of trials and
trial amendments/updates. This section contains a summary of the information required for the .xls file. See Using CTRP Registration Templates .
You must provide trial data in the Microsoft Excel format, .xls.
How to Prepare Trial Data Files
1.

1. Download the following batch upload templates (Excel spreadsheets) containing the mandatory and optional data for multiple trial
registration and participating sites from CTRP Trial Registration Batch File Templates . For instructions, see Downloading Trial
Registration Templates.
2. Enter the trial data elements as specified in the templates. For participating sites, see Using CTRP Registration Templates .
The .xls file that contains the trial data you want to register via the CTRP batch upload feature, and the trial-related documents
associated with it, must meet certain requirements for successful registration. Refer to the specifications below and in Preparin
g Trial Document ZIP Files.

Trial Requirements

To ensure successful submission, ensure that your trials conform to the following criteria:
Study Type

1. Complete
2. Interventional only

Data Table 4 Funding Sponsor Categories

1. National
2. Externally Peer-Reviewed
3. Institutional

Processing Statuses for Trial Amendments

1. Abstraction Verified Response
2. Abstraction Verified No Response

Processing Statuses for Trial Updates

Accepted and beyond

Data File Requirements

Ensure that the batch data files conform to the following criteria:
Number of Trials per File

100 maximum

Number of Grants per Trial

Multiple

Number of IND/IDEs per Trial

Multiple

Responsible Party or Sponsor
Options
Number of "Other" Trial Identifiers

1. Contact
2. Generic Contact
Multiple

Data Submission Options

1. XML file is required for trial submission to ClinicalTrials.gov
2. XML file is not required for trial submission to ClinicalTrials.gov

Person and Organization
Information Options

1. PO-ID for the person or organization
2. Set of mandatory attributes for person or organization
You can request a list of CTRP persons and organizations along with PO-IDs from the
CTRO at ncictro@mail.nih.gov.
Or, you can use the search organization/person feature in Registration to ascertain
PO-IDs.

Template Requirements

1. List trial elements required for registration in the order specified in the Batch Upload Data Element Spec tab in the batch upload template.
2. Do not change the spelling of data elements, valid values, or the order of the columns in the spreadsheet. Changes to spelling or to the
order of the trial elements will cause the upload to fail. Similarly, the addition of new/extra trial elements will also cause a failure. The
column headings are not case-sensitive. For example, a heading could be "Lead Organization" or "LEAD ORGANIZATION".
3. Conform to the valid values guidelines when entering trial data. Valid values for each of the trial elements, where applicable, are listed in
the Batch Upload Data Element Spec tab and the Valid Values tab in the batch upload template.
4. Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.
5. Select and delete any columns that do not have column headings.
You can enter dates in the following formats:
1. MM/dd/yyyy
2. MM-dd-yyyy
3.

3. yyyy/MM/dd
4. yyyy-mm-dd
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Preparing Trial Document ZIP Files

Trial documents include Protocol, IRB approval, Informed Consent, Participating Sites, Change Memo, and other document types. Upload these
files together in one Zip file.
You are not required to upload trial-related documents when updating existing trial records.
How to Prepare Trial-Related Document ZIP Files
1. List the document names (including their extensions) in the file containing the trial data. You can specify up to seven (7) files in one single
trial record.
2. Zip together all applicable trial documents (e.g., Protocol, IRB approval, Informed Consent, Participating Sites, Change Memo) for the
trials in the data file. (The Batch Upload application does not support the native MacOS X file compression utility.) If you are uploading
trial amendments, provide either a Change Memo or Protocol Highlight document. Be sure to include the Change Memo or Protocol
Highlight document file names in your data file (.xls).
Do not include the following items in Zip files that you intend to upload:
a. Folders or other Zip files
b. Path names. Some ZIP/compression tools provide an option to include the entire file path name when compressing a
file. Path names describe the location of the file.
Trial-Related Document Requirements
Basic criteria for trial-related documents include the following:
File
Types

1. Microsoft Word (.doc)
2. Adobe PDF
CTRO staffs use the information in the submitted trial documents to register the details of your trial. They often copy and paste
this information during the registration process. They can copy text from Word documents, but not from scanned documents. If
you intend to submit your Word documents as PDFs (for example, to prevent editing), do not scan them. Instead, convert them to
PDFs. For instructions see Converting Files to PDFs .

File
Names

Trial document file names must be unique. To avoid overwriting existing files when the system extracts your latest upload,
rename the document files if they are not unique. For example, prefix files with a unique trial identifier such as XXXX_document
name.doc.
If using trial identification prefixes, ensure that each of a given trial's document file names is unique.

Number
of Files
Permitted
per Trial

7 maximum

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Submitting Trial Document ZIP Files

The CTRP provides you with the link to the batch upload website when it issues authorization to upload batches.
You must upload each of the following types of files when you register multiple trials:
Data documents - Documents that contain all the requisite information about the protocol.
Trial-related documents - Protocol and IRB documents, among others.
How to Upload Trial Registration Batch Files
1. Navigate to the batch upload URL that you received from the CTRO. The Batch Trial Upload page appears. An asterisk (*) indicates a

1.
required field.

Batch Trial Upload Page
2. In the Organization Name field, type the name of the organization associated with the trials you want to register.
3. Next to the Trial Data field, click Browse and navigate to the file that contains all of the trial data.
4. Next to the Documents Zip field, click Browse and navigate to the .zip file that contains all of the trial-related documents. You do not
have to upload a Zip file if you are updating a trial.
5. Click Upload Trials. The Batch Trial Upload Confirmation page appears.

6. To upload more files, click the click here link, which directs you back to the Batch Trial Upload window.
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.
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Registering Abbreviated (Industrial and Other) Trials
You can register Industrial/Other trials in the CTRP by importing them directly from ClinicalTrials.gov. You must enter a ClinicalTrials.gov Identifier
(NCT ID) for each trial you register. If the trial you want to register does not have an NCI ID, or if you do not know it, contact the CTRO for
assistance at ncictro@mail.nih.gov.
The system registers the trials you import from ClinicalTrials.gov as Abbreviated trials. To classify a trial as "Other", contact the Clinical
Trials Reporting Office staff at ncictro@mail.nih.gov after importing/registering the trial in the CTRP system.

For more information about Data Table 4 categorization, see Guidelines for Abbreviated Trials.
How to Register Industrial Trials
1. On the toolbar, click Register Trial, and select Industrial/Other.
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, or, click
the Help icon (

) next to each category.

The Import ClinicalTrials.gov Trials page appears.

2. Enter the ClinicalTrials.gov Identifier, and then click Search Studies.
The system searches for the ID you entered. If it finds a match in the CTRP, you can not import the trial.
3. If the system does not find a match in the CTRP, the trial record from ClinicalTrials.gov appears.

4. Click Import Trial From ClinicalTrials.gov.
While it is possible for two users to attempt to import a trial at the exact same time, the system cannot process simultaneous
imports. If you receive an error message the first time you attempt to import a trial, wait a short while, and then try again.
The trial is registered in the CTRP and assigned a unique NCI identifier with the processing status Submitted. The system synchronizes
the imported record in the CTRP with the one in ClinicalTrials.gov.

5. To add your site as a participant in the trial, click Add My Site. The Add Participating Site page appears.

The Participating Site list contains all organizations in the Organization Family associated with your CTRP account.
6. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page
appears.

7. Complete the fields as per the instructions in Adding Your Site to Abbreviated Trials, and then click Save.
The system sends you an email message when the CTRO has accepted the trial for registration in the CTRP. If your trial is not Industrial,
contact the CTRO at ncictro@mail.nih.gov to request categorization of the trial as either National or Externally Peer-Reviewed.
The system synchronizes Industrial and Other trials currently registered in the CTRP with ClinicalTrials.gov trials every night by comparing their
ClinicalTrials.gov Identifiers. The system updates CTRP trial records with the data imported from ClinicalTrials.gov if it finds matching records.
The CTRP system does not import Person information from ClinicalTrials.gov.
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Printing Trial Information

You can print a copy of the trial details to facilitate the review and/or keep for your records. You must review the trial in order to access the print
feature.
How to Print Trial Information
1. Scroll to the bottom of the Register Trial page, and then click Review Trial. If necessary, provide any missing information.
2. Scroll to the bottom of the Review Trial Details page, and then click Print.
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Editing Trial Details
You can edit the details of the trial that you are registering before you submit the trial to the CTRP. If you want to edit a registered trial that you
own, follow the instructions in Updating Trials.
How to Edit Trial Details
1. Scroll to the bottom of the Register Trial page, and then click Review Trial.
2. Scroll to the bottom of the Review Trial Details page, and then click Edit.
The Register Trial page displays all information you have provided in editable form.
3. Make changes as necessary, and then click Review Trial.
4. After you have reviewed your edits, click Submit.
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Completing and Deleting Saved Drafts
During the course of registering a trial, you can save the information you have already provided as a draft , and return to it later. Once you retrieve
your draft, you can complete the registration or delete the draft altogether.
How to Complete or Delete Saved Drafts
1. Retrieve the draft by searching for it using the Search Saved Drafts option. (For details, see Searching for Trials .)
Saved draft records are listed on the Search Results page.

2. Do one of the following in the appropriate Action column on the right side of the table:
a. To delete the record, click Delete. The draft record is deleted from the system permanently.
- or b. To complete the record, click Complete.
The Register Trial page displays all the information you provided previously. You can complete the rest of the information by following the steps in
Registering a Complete Trial.
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Updating Trials v4.3
Updating Trials v4.3

Topic Links
About Trial Updates
Updating Trial Information
Updating Trial Statuses
Updating the Trial Start, Primary
Completion, and Completion Dates
Start, Primary Completion,
and Completion Date
Rules
Updating Participating Site
Statuses in Complete Trials
Status Transitions
Reviewing and Submitting Trial
Updates
Editing Updated Details
Printing Updated Trial Information
This section describes how to update trials that are currently registered and verified in CTRP.

About Trial Updates
Registration enables you, in the role of trial owner, to update trials that have been registered with the CTRP previously. You can update only
those trials that have been previously accepted (i.e., the processing status must be Accepted or a subsequent processing status.)
You can also update the trial status and trial status start/completion dates without having to update other trial details. See Changing Trial Status
Information for instructions.
Use the Update Trial feature when changes to the trial are not a consequence of changes to the protocol document. Use the Amend
Trial feature---for Complete trials only---when changes to the trial involve changes to the protocol document that require IRB approval.
You can update both trial and participating site information for Industrial/Other trials using the Available Actions column.

Updating Trial Information
As trial owner, you can update a subset of the information included with the original trial submission, including the following:
ClinicalTrials.gov Identifier (other than Industrial/Other trials)
Other Identifier
Local Trial Identifier (Industrial/Other trials)
Title (other than Industrial/Other trials)
Accrual Disease Terminology (other than Industrial/Other trials)
NIH grant information (for NIH-funded trials).
You can add grants but you can not update existing grant information.
Participating site
Site recruitment status and associated date and site program code for abstracted trial sites. See Recording Trial Statuses and
Dates .
Status dates
Changing the overall trial status must reflect changes to the trial status at the site. For example, if you change the overall status
from Approved to Active, you must change the recruitment status from Not Yet Recruiting to Recruiting.
Trial documents
Documents you upload when using the Update Trial feature do not overwrite existing documents.
You can change the trial status information directly from the Search Results table without having to open the trial record. To use this method, in
the Search Results table's Action column, select Change Status and make your changes as per the instructions in Recording Trial Statuses and
Dates .

Tip
You can also update trials in batches. See Registering Multiple Complete Trials in Batch Files .

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

"Available Actions" Columns for Complete trials - Select Action List

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

Update Trial page for Complete trials

Update Trial page for Industrial trials

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

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

5. If applicable, enter an ClinicalTrials.gov Identifier, and then click Add ClinicalTrials.gov Identifier.
You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make changes thereafter, contact the
CTRO at NCICTRO@mail.nih.gov.

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

6. Make changes to the fields as necessary. Instructions for recording each of the fields are provided in Registering New Trials .
7. If appropriate, upload any new or updated documents. See Recording Trial-Related Documents .
If you upload an IRB document, the CTRO reviews the updated record you submit and makes changes to the record as necessary. For
example, if you upload an IRB document for a trial currently in the In Review state, the CTRO updates the IRB information section of the
trial record (e.g., IRB status and approval number).
8. To review the information you provided, click Review Trial.
The system checks the updated information for errors, and displays the results at the top of the Update Trial page.
9. If necessary, correct any errors, and click Review Trial. Repeat this cycle until your update is error-free.
10. Submit the trial update.
The system sends you an update notification—with the details of what has changed—whenever you update accepted trials.
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Updating Trial Statuses
You can update trial statuses for the trials you own without having to update other trial details.
Updating trial statuses from the Search Results table
After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to
open the trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change
Status.

Errors and Warnings
The system validates each new status as you add/update it, as well as when you review the trial information before submitting the
update.
If you add a status that does not conform to the rules provided in Status Transitions, the system displays errors and/or warnings.
For example, if you add the status Closed to Accrual the system warns you that both the status In Review and Approved are missing. Because
Warnings indicate that fixing the record is optional, you do not have to add the indicated statuses. However, Errors indicate that you must record
the missing status (in this case, Active) in order to submit the trial for registration
How to Update Trial Status Information
1. Search for the trial whose status information you want to update by following the instructions in Searching for Trials .
The Search Results table displays the results of your search and actions available (if any) for each record.

2. In the Available Actions column, click Select Action > Change Status, or if you want to update other aspects of the trial coincidentally,
click Update.

The Update Trial Status window displays Trial Status fields and lists the previously-recorded trial statuses in the Trial Status History
section.

3. Edit or add a new status as necessary (see Recording Trial Statuses). If you changed the status to Administratively Complete, Withdrawn
, or Temporarily Closed, enter the reason for the status change.
If a Complete trial reaches any of the statuses below, the system closes the trial at all participating sites, and sets their trial
statuses to match those of the trial that closed.
Closed to Accrual
Closed to Accrual and Intervention
Administratively Complete
Complete

The system displays the following warning if you enter any of the statuses above:

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

Errors and Warnings
The system validates each new status as you add it, as well as when you review the trial information before submitting the trial
for registration.
If you update or add a status that does not conform to the rules provided in Recording Trial Statuses and Dates, the system displays
errors and/or warnings. Warnings indicate that fixing the record is optional, you do not have to add/update the indicated statuses.
However, Errors indicate that you must record the missing status in order to update the trial.
If you update a trial registered prior to the CTRP v4.2 release, the Trial Status History records may contain errors and warning as shown
below. You must correct each of the errors before you can update the trial.

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

6. Fix any errors as necessary, and then click Review.
7. Click Submit. See Recording Trial Statuses and Dates for detailed instructions.
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Updating the Trial Start, Primary Completion, and Completion Dates
The trial status dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Start,
Primary Completion, and Completion Date Rules.
You can update trial start/completion dates for trials you own without having to update other trial details.
Updating trial statuses from the Search Results table
After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to

open the trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change
Status.

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

Description/Instructions

Trial
Status
Date*

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

Trial
Status

Select the trial’s accrual status from the drop-down list. Valid values are as follows:
In Review - Trial is currently under IRB review.
Withdrawn - Trial has been withdrawn from development and review prior to enrollment of the first participant.
Approved - Trial has been approved, but is not yet recruiting or enrolling participants.
Active - Trial is open for accrual and enrollment.
Enrolling by Invitation - Participants are being (or will be) selected from a predetermined population.
Temporarily Closed to Accrual - Participant recruitment or enrollment has been halted prematurely but may resume.
Participants already on trial continue to receive intervention.
Temporarily Closed to Accrual and Intervention - Participant recruitment or enrollment has been halted prematurely but
may resume. Participants already on trial do not receive intervention.
Closed to Accrual - Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive
treatment and/or examination).
Closed to Accrual and Intervention - Trial has been closed to participant accrual. Participants already on trial do not receive
treatment, but continue to be monitored for endpoints such as long-term survival.
Administratively Complete - Participant recruitment or enrollment has been halted prematurely (for example, due to poor
accrual, insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the trial do not receive further
treatment or examination.
Complete - Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and
participants are no longer monitored for trial endpoints (i.e., last patient's visit has occurred). The trial has met its objectives.

Why
Study
Stopped

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

Valid trials used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial
Status Values in the CTRP and ClinicalTrials.gov.
Start, Primary Completion, and Completion Date Rules

Valid dates for a given trial status depend on the other values you have entered, and whether those dates are Actual (current, or past) or Anticipat

ed (future).
The following diagram illustrates these rules. The arrow at the top of the diagram represents a time line for the life of a trial. The three horizontal
bands in the lower section of the diagram represent, from top to bottom, the relative date (actual or anticipated) rules for trial Start Date types,
Primary Completion Date types, and Completion Date types.

The following table provides the rules for trial status dates as diagrammed.
Rules for Status/Dates relationships
If this is true...

Follow this rule

Current Trial Status is anything other than In Review, Approved, or
Withdrawn

Trial Start Date must be Actual (solid band)

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated (diagonal stripes
band)

Current Trial Status is Complete

All date types must be Actual (solid band)

Completion Date is Actual
The Completion Date is always the same as, or later than, the Primary Completion Date

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Updating Participating Site Statuses in Complete Trials

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

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

3. Select new statuses and enter dates as necessary.
4. You also have the option to specify a program code for each site.
5. Click Review Trial.
If you entered invalid values, error messages display instructions for correcting the statuses and/or dates.

6. Fix any errors as necessary, and then click Submit.

If a Complete trial reaches any of the statuses below, the system closes the trial at all participating sites, and sets their trial
statuses to match those of the trial that closed.
Closed to Accrual
Closed to Accrual and Intervention
Administratively Complete
Complete

Status Transitions
The rules that apply to trial status transitions also apply to participating site status transitions.
The table and diagram below provide rules for ensuring that you record valid transitions between trial statuses.
Trial Status Flow Relationships
A trial can proceed from this
status…
In Review

Directly to this status

Approved
Withdrawn

Or to this status

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

Approved

Active/Enrolling by
Invitation
Withdrawn

Active/Enrolling by Invitation

Closed to Accrual

Closed to Accrual and
Intervention

Completed
Administratively
Completed

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

Temporarily Closed to Accrual

Temporarily Closed to Accrual
and Intervention

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

Temporarily Closed to Accrual
and Intervention

Administratively Completed

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

Trial Status Transitions

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

You can edit your updated trial details after you have reviewed them at any time before you submit them to the CTRP.
How to Edit Updated Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit.
The Update Trial page displays all information you have provided, in editable form.
2. Make changes as necessary and then follow the instructions in Reviewing and Submitting Trial Updates .
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Printing Updated Trial Information
You can print a copy of the updated trial to facilitate the review and/or keep for your records. You must review the trial update in order to access
the print feature. For instructions on reviewing the trial, see Reviewing and Submitting Trial Updates .
How to Print Updated Trial Information
1. Review the updated trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.
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Amending Complete Trials v4.3
Amending Complete Trials v4.3

Topic Links
About Trial Amendments
Amendment Process Life Cycle
Amending Trials
Reviewing and Submitting
Trial Amendments
Editing Amended Trials
Printing Amended Trial
Information
This section describes how to amend trials currently registered and verified in CTRP.

About Trial Amendments
In your role as trial owner, you can amend National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP
previously and have reached the Abstraction Verified Response/No Response processing status. (See Trial Processing Statuses.) You can
amend a trial you submitted or own if the trial status is In Review or Approved. (See Trial Status Values.)
The CTRO reviews and abstracts amended trial data just as it does with original submissions.
The ability to amend a trial is restricted by its trial status
You can not amend trials in the Complete, Administratively Complete, Withdrawn, or Terminated statuses.
Most of the information, including documentation, that is required for original submissions is also required in amendments. To ensure that these
requirements are met, you can review, edit, and print your amended data using the Registration features prior to submission.
You can also amend trials in batches. See Preparing Data Files .

Amendment Process Life Cycle
The CTRP processes submissions in much the same way as it processes original trial data. (For information, refer to Typical Life Cycle of a Trial.)
You may need to submit an amendment more than once during the course of your study, and the process is repeated each time you submit an
amendment.
The progression of your trial throughout the phases of the life cycle relies on a series of communications. These communications take the form of

email messages between you and the system at certain milestone events, as follows:
1. The system sends you a submission confirmation letter.
2. The CTRO validates the new data and documents you provided, and the system sends you an acceptance (or rejection) message.
a. If the amendment is rejected, the system provides the reason for rejection and reinstates your latest verified trial submission.
b. If your amendment is accepted, the CTRO abstracts all the trial details.
3. When abstraction is complete, the CTRO sends you a Trial Summary Report (TSR) that includes all the newly-modified data in the
CTRP. (If appropriate, the CTRO also sends an XML document with all the newly-modified data. XML documents are available for trials
that have been designated for import into ClinicalTrials.gov.)
4. You review and validate the new TSR and email your approval to the CTRO.
5. If you request a change, the CTRO makes corresponding modifications and re-sends the TSR (and XML document, if appropriate).
The amended trial appears in your Search My Trials results list upon acceptance.
The TSR contains all the information that you submitted and all the trial data abstracted by the CTRO.

Amending Trials
In your role as trial owner (original submitter or current owner), you can amend only Complete trials. The trials you own are listed when you use
the Search My Trials feature. See Searching for Trials .
In addition to rules provided in Registering New Trials , the following rules apply to amendments:
You can create a new NIH grant record only if you can provide all of the following details:
Funding Mechanism
NIH Institution Code
Serial Number
NCI Division/Program
You can not change the following existing information:
NCI trial identifier number
NIH grant number
IND/IDE serial number
The following documents are required with submission:
Amendment Protocol
Registration requires submission of the Complete protocol (for non-industry trials), or a summary of the protocol (for industry
trials), and an IRB Approval document. For multi-center trials, a list of participating sites with contact information is required. If
the protocol does not include the Informed Consent or participating sites, submit them separately.
Accepted Documents
You can submit clean (original) amendment protocol documents or documents that have been marked up, with or
without using the Track Changes feature.
Change Memo – Contains a summary of changes to the original, or last amended, trial submission
(One or the other of the Change Memo and Protocol Highlight documents is required. You do not have to submit both of these
documents.)
Protocol Highlighted Document
IRB Approval for the amended protocol

A trial may have more than one owner. Review the recorded information carefully to see if another owner has modified the trial.

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

3. In the Available Actions column, click Select action > Amend.
The Amendment Trial page displays the data currently registered with the CTRP.

4. Select or enter the appropriate information in the text fields and drop-down lists, following the instructions provided in Registering New
Trials .
If a Complete trial reaches any of the statuses below, the system closes the trial at all participating sites, and sets their trial
statuses to match those of the trial that closed.
Closed to Accrual
Closed to Accrual and Intervention
Administratively Complete
Complete
The system displays the following warning if you enter any of the statuses above:

You are required to provide information for all fields marked with an asterisk (*).

You can select a different disease code only if the trial has not accrued any subjects to date.
5. Review the amendment. See Reviewing and Submitting Trial Amendments .
6. Submit the amended trial to the CTRP.
The system sends you an email notification — with the details of what has changed — whenever you amend accepted trials.

Return to top of page
Reviewing and Submitting Trial Amendments

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

You can edit your amended trial details after you have reviewed them at any time before you submit them to the CTRP.
How to Edit Amended Details
1. Scroll to the bottom of the Review Trial Details page, and click Edit.
The Amendment Trial page displays all information you have provided in editable form.
2.

2. Make changes as necessary and then follow the instructions in Reviewing and Submitting Trial Amendments .
Editing Trial-Related Documents
The Edit Trial page lists all documents that were submitted with previous trial submissions. You can view, but not delete these
documents. However, you can remove/replace the documents associated with the amendment you are submitting.
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Printing Amended Trial Information

You can print a copy of the amended trial to facilitate the review and/or keep for your records. You must review the amendment in order to access
the print feature. For instructions on reviewing the trial, see Reviewing and Submitting Trial Amendments.
How to Print Amended Trial Information
1. Review the amended trial.
2. Scroll to the bottom of the Review Trial Details page, and click Print.
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Adding Your Site to Abbreviated Trials v4.3
Adding Your Site to Abbreviated Trials v4.3

Topic Links
Using the Add My Site Feature
Viewing Participating Sites
Updating Participating Site
Organization Records
This section provides instructions for adding your affiliated organization and its family members as participating sites in Abbreviated trials.
You can use the Add My Site feature to add your site to eligible trials one at a time. Site Administrators can use the Add Sites feature when
adding their sites or family member organizations to multiple trials, or add multiple participating sites to the same trial.
Before you begin, ensure that you have indicated your affiliated organization in the CTRP
To verify that you have indicated your current organization affiliation, on the top right corner of any page, click Your Username > My
Account and review your account information. You can add/update your affiliation by following the instructions in Creating CTRP
Accounts .

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

Trial Attribute

Requirement

Lead Organization

Not an organization in RSS

Your Organization

Not currently participating in the trial

Trial Processing Status

Accepted or beyond

Once added, you can update your site's record at any time.
Trial information that you can update after adding your site includes the following:
Organization's local trial identifier
Site principal investigator
Site-specific program code
Site recruitment status and dates

How to Add Your Organization as a Participating Site
1. Select the trial that your site is participating in. The Available Actions column in the search results table displays actions currently
available for the trial.

2. In the Available Actions column, click the Select Action button and click Add My Site. The Add Participating Site page appears.

The Participating Site list contains all organizations in the Organization Family associated with your CTRP account.
3. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page
appears.

4. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*)
indicates a required field.
Field

Description/Instructions

Local Trial Identifier*

Enter the identifier used at the participating site.

Site Principal Investigator*

Click Look Up to search for, and select, the site principal investigator.

Site Specific Program Code

Optionally, enter a program code for the participating site.

5. Add site recruitment status information:
a. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An
asterisk (*) indicates a required field.

5.
a.

Field

Description/Instructions

Site
Recruitment
Status Date
*

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

Site
Recruitment
Status*

Select the current stage or state of the trial or study.

To ensure that you record valid status dates, review the information provided in Trial Status Date Rules in the
CTRP.

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

b. Click Add Status. The Site Recruitment Status History section appears, displaying the site recruitment information you entered.

Site Recruitment Status- No Warnings or
Errors

Site Recruitment Status- With Warnings
and an Error
c. Repeat the process of entering a status date, entering a status, and clicking Add Status until you have entered all statuses for
the site.
6. If the system displays Errors or Warnings indicating that the status you added is invalid, do one of the following.
a. To edit the status, in the Actions column, click the Edit icon. Then, in the Edit Trial Status dialog box, make changes as
indicated in the Error and/or Warning message.

b. To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the
record, and then add the correct status information.
8. Click Save. Your information is added to the trial details.

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

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

Return to top of page

Updating Participating Site Organization Records
If you are affiliated with a Cancer Center that has been added to a trial as a participating site, the following points indicate whether you can update
that participating site:
Appointed participating site record owner(s) and the trial owner(s) can update information about their respective organizations in the
same trial record.
If your affiliated organization is a member of the parent organization's family (that is, a Cancer Center's family), you can also update your
organization's sibling sites (that is, other participating sites in the Cancer Center's family).
If you are affiliated with the Cancer Center that is acting as the parent organization, you can update any organization in the family.
For information about appointed participating site records, see Managing Trial Ownership .
How to Update Participating Site Organization Records
1. Search for the trial that you are participating in by following the instructions in Searching for Trials.
2. In the Available Actions column, click Select Action > Update My Site.

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

3. From the Participating Site drop-down list, select the site you want to update.
4. Click Submit. The Update Participating Site page appears. The Organization Name field is pre-populated with the organization you
selected on the previous page.

5. Enter the new information in the fields as appropriate.
6. If the system displays Errors or Warnings, follow the instructions in Using the Add My Site Feature to edit or delete the records.
7. Click Save. Your information is updated.
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Registration Site Administration v4.3
Registration Site Administration v4.3

Topic Links
About Site Administration
Granting and Revoking
Administrative Authority
Assigning and Unassigning Accrual
Access
Assigning and Unassigning
Accrual Access by Trial
Assigning and Unassigning
Accrual Access by Site
Assigning and Unassigning
Accrual Access by
Organization Family
Viewing Accrual
Assignment History
Managing Trial Ownership
Assigning Trial Ownership
Displaying Trial Ownership
Adding Sites

This page provides instructions for site administrators. A site administrator is a user with administrative privileges who is responsible for reviewing
and updating user access to trials owned by the organization, and for assigning site administrator status to other users in the organization. This
page introduces you to site administration management and provides instructions for granting and revoking administrative authority.

About Site Administration
Each organization registered in the CTRP system can have more than one site administrator. You can request primary site administration
authority from the CTRO via the "Request for Admin Access" feature on the "My Account" page when you first complete your account profile and
provide your organization affiliation. Refer to Creating CTRP Accounts . Otherwise, request administration authority from the current site
administrator.
To display the administrator(s) currently assigned to your organization, on the My Account page, below the Organization Affiliation fi
eld, click View Admins. This feature is displayed only for those users whose affiliated organizations currently have registered admins.

Granting and Revoking Administrative Authority
The relationships between administrators and trials in a single organization are as follows:
An organization can have the following:
One original site administrator
Many site administrators appointed by the original administrator
Many trials, providing that the organization plays the lead organization role
Many users affiliated with the site who can submit and own trials
A trial can have the following:
One submitter
One organization affiliation, defined by the lead organization
Many trial owners
Site administrators are trial owners by default if the site administrator's affiliated organization is the trial's lead organization. A site administrator
can be added explicitly as an owner of any trial. Refer to Managing Trial Ownership.
A site administrator can do the following:
Display trial ownership
Manage trial ownership
Manage site record ownership
Manage Accrual access
Manage the administrative rights of other users in the organization
Revoke own administrative rights

Site administrators do not receive system-generated emails automatically
System-generated emails (including TSRs) are sent to a site administrator only if the site administrator's affiliated organization is the

trial's lead organization, or if the site administrator is the trial submitter and/or trial owner. The site administrator can also manage email
notification globally on the My Account page.
As a site site administrator, you can grant and revoke administrative rights to other users in your organization. (You can grant/revoke
administrative authority to users who have a CTRP account and whose organizational affiliation is the same as your own.) Site administrators are
the only Registration users who can see and access the Site Administration menu.
How to Grant and Revoke Site Administrator Rights
1. On the toolbar, click Administration > Site Administration.
The Site Administration page appears, listing the administrators to whom administrator rights have previously been granted, if applicable.

2. Search for the Registration user for whom you want to adjust administrative rights: specify the user by first name, last name, or email
address, and then click Search. The user's name appears in the Search Results list.
a. To promote the user to site administrator, select the check box in the Allow as Site Admin? column.
As a site administrator you can revoke your own administrative rights. Use caution if you do so because you can not
promote yourself thereafter.
b. To revoke administrative access, clear the check box under the Allow as Site Admin? column.
3. Click Save.

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As a site administrator, you can view a history of your organization's accrual access assignment on a per-trial basis.

How to View Accrual Assignment History by Trial
1. On the toolbar, click Administration > Accrual Access > View.
The Accrual Access Assignment by Trial page lists all current access assignments by trial, grouped by trial category.

To navigate the table, refer to Working with Tables and Search Results.

Assigning and Unassigning Accrual Access

Site Administrators can authorize users to submit subject accrual data for trials that have been fully abstracted and verified. Once assigned, users
can submit accrual data for all trials associated with their affiliated organization or organization family members. For Complete trials (Institutional
and Externally Peer Reviewed), the organization must be a lead; for Abbreviated trials (Institutional), the organization must be a participating site.
Assignment at the organization level pertains to trials that the organization has registered in CTRP and extends to those that it will register in the
future. Similarly, assignment at the organization family level pertains to trials that any member organization has registered in CTRP and extends
to those that it will register in the future.
Access to CTEP and DCP trial accruals is restricted to the CTRO only.
The table below outlines the access and trial assignment rules for Complete (Institutional and Externally Peer-Reviewed) and Abbreviated trials.
Access/Assignment
Who can assign
access?

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

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

Who can be assigned
access?

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

Any registered user
affiliated with the
assigner's organization
(including the site
administrator)

What types of trials
can be assigned?

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

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

How is access
assigned?

By trial
By Organization
By Organization Family member

By trial
By participating site

The system automatically assigns the Organization Family Accrual Submitter access to
any trial registered by new organizations added to an organization family in the future. It
withdraws access if the Organization Family Accrual Submitter's organization is
removed from the organization family in the future.
Who can submit
accrual data?

Which trials can the
Organization Family
Accrual Submitter
submit accrual data
to?

Any assigned user, for any organization trials for which the assigner's organization is the
Lead Organization

All complete trials registered by the submitter's organization or family member
organization
Trials currently registered in CTRP
Trials that the organization registers in CTRP in the future, once abstracted

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

___

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Assigning and Unassigning Accrual Access by Trial

As a site administrator, you can assign a user Accrual access to any trial that the user submitted to the CTRP or currently owns.
How to Assign Accrual Access
1. On the toolbar, click Administration > Accrual Access > Manage.
The Manage Accrual Access page appears.

2. Select an assignment type.
Select Assign user access to individual trials to assign specific trials to specific users. If you select this option, the Select a
trial category list appears where you can narrow the list of trials to a category.
Select Make user a Site Submitter to grant users rights to submit accruals for all trials in CTRP that have been submitted or will
be submitted by the affiliated site.
Select Make user an Org Family Submitter to grant users rights to submit accruals for all trials in CTRP that have been
submitted or will be submitted by any site that is a member of the organization family.
3. From the Select a user list, select the user to whom you want to assign or unassign accrual submission privileges.
The list of trials available for accrual submission for the user you selected appears in the Not Assigned list on the left side of the page,
and trials to which access had previously been granted (if any) appear on the right.
To view the entire text of a trial's title, hover your cursor over the part of the title displayed.

Trials in the Not Assigned list that have not been validated appear in grey text and are unavailable for selection.
4. From the Not Assigned trial list, select the trial to which the user will submit accrual data, and then click the single arrow ( > ) under Assi
gn. Or, to assign all eligible trials, click the double arrow ( >> ).
You can select multiple trials
To select multiple trials, click one trial, then press and hold the CTRL (or CMD) key and click one or more others. Then click the
single arrow ( > ) under Assign.
A comment box appears.

5. Optionally, in the Comment box, enter a comment about this assignment, and then click Save.
Comments are optional. You can leave the comment field blank and still save it. To abort the assignment, click Cancel instead.
A message confirms your assignment. The assigned trial(s) appear in the Assigned list.
6. To unassign access, from the Assigned trial list, select the trial you want to unassign, and then click the single arrow ( < ) under Unassig
n. Or, to unassign all trials, click the double arrow ( << ).
7. Optionally, enter a comment in the Comments box, and then click Save.
The trial(s) you selected are moved to the Not Assigned list, and the user will no longer have access to them.
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Assigning and Unassigning Accrual Access by Site

As a site administrator, you can assign a user Accrual access globally by site.
How to Assign Accrual Access by Site
1. On the toolbar, click Administration > Manage.
The Manage Accrual Access page appears.
2. Select Make user a Site Submitter.

3. Select the user from the Select a user drop-down list.
4. Click Assign/Unassign.
5.

5. To unassign access, click Assign/Unassign again.
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Assigning and Unassigning Accrual Access by Organization Family

As a site administrator, you can assign a user Accrual access globally by organization family.
How to Assign Accrual Access
1. On the toolbar, click Administration > Manage.
The Manage Accrual Access page appears.
2. Select Make user an Org Family Submitter.

3. Select the user from the Select a user drop-down list.
4. Click Assign/Unassign.
5. To unassign access, click Assign/Unassign again.
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Viewing Accrual Assignment History

As a site administrator, you can view a history of your organization's trials to which users have been assigned/unassigned user access.
How to View Accrual Assignment History
1. On the toolbar, click Administration > Assignment History.
The Accrual Assignment History page lists all access assignments and assignments.

2. To navigate the table, refer to Working with Tables and Search Results.
3. To export the assignment history to a file, click CSV (comma-separated values) or Excel in the bottom left corner.
Your browser prompts you to open or save the file.
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Managing Trial Ownership
Trials are associated with the user who last submitted the trial, and with the last submitter's affiliated organization.
For example, in the figure below, Isabelle Autissier (username = CTRPDOC1) submitted the trial while affiliated with M D Anderson. She is the
Last Submitter, and trial owner. And M D Anderson is the last Submitter Organization and trial owner.

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

If Isabelle Autissier changes her organization affiliation to another within the organization family such as U.T. M.D Anderson Cancer Center after
having submitted the trial, both she and her original organization retain trial ownership.

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

The example above is based on Complete trials. The same principals apply to Industrial trials but site record ownership rather than trial
ownership is affected by affiliate changes.

Assigning Trial Ownership

As a Site Administrator, you can assign and unassign trial ownership rights to multiple users in your affiliated organization and its family member
organizations, and multiple trials at the same time. (Trials displayed on the Manage Trial Ownership page are those that you have submitted or
those submitted by users if the trial's lead organization is the same as your affiliated organization or its family member organizations.)
For example, you can grant ownership of one trial to three CTRP users within your organization. Or, you can grant one user ownership of three
trials.
Additionally, you can indicate which of the owners you assign will receive notifications about the trial(s) via email.
Users must have a CTRP account, complete with organizational affiliation, in order for you to grant them trial ownership.
For Abbreviated trials, owners are responsible for updating their affiliated organization's information on trials in which their site is a participant,
using the Update My Site action. Owners can update the following information:
Organization's local trial identifier
Site principal investigator
Site-specific program code
Site recruitment status and dates

Trial ownership requirements
You may not be able to change trial ownership using the Manage Trial Ownership functionality in certain circumstances. For example,
you may not be able to change trial ownership if the trial status is Complete rather than Active, and the lead organization is not the trial
submitter's affiliated organization. (Refer to Recording Site Recruitment Statuses and Dates .) However, you can request trial ownership
changes by contacting the CTRO. When requesting trial ownership changes, include the new owner's first name, last name, and email
address. Ensure that the user has registered in CTRP or has a valid CTRO account.
Your affiliated organization is stored with your account information on the My Account page. Your affiliation determines which trials and which
users you can assign.

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

___

How to Assign and Unassign Trial Ownership
1. On the toolbar, click Administration > Trial Ownership > Manage.
The Manage Trial Ownership page displays the names of your affiliated organization or it's family member organization(s) users on the
top of the page, and trials that your organization owns as a Lead Organization or Participating Site below the list of names.

2. Under Manage trial ownership for, select which role your affiliated organization or its family member organization(s) play(s).
a. For Complete trials, select Lead Organization.
b. For Abbreviated trials, select Participating Site.
3. To indicate which users will have the ability to update and amend selected Complete trials; or update Abbreviated trials, select one or
more user names on the list.
You can select or deselect all names, or filter the list of names
To select all names, select the check box on the left side of the column heading. Click it again to deselect all names.
To filter the list of names, in the Search field, type one or more characters contained in a user's name or email address. The
list is filtered as you type subsequent characters.
4. In the list of trials at the bottom of the page, under All Available Trials, or All Abbreviated Trials, select the trials to assign to the
user(s), and then click the Assign icon ( > ).

5. To unassign trials, under Trial Ownership Assignments, or Site Owner Assignments, select the user(s) you want to unassign, and
click the Unassign icon (<).
6. For Complete trials, indicate which trial owners should receive email notifications about the trial(s). In the Email Notifications? column,
click the Yes or No button. To indicate that all owners should receive/not receive email, in the Email Notification column header, click Al
l > Select Yes/No for all.

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Displaying Trial Ownership

As a site administrator, you can display trial ownership for any trial owned by your site for which your organization or its family member
organization is the lead organization. Trial owners can view trial details, update trials, and amend Complete trials. Additionally, you can indicate

whether a user would like to receive system notifications, including TSRs and XML files, on a trial-by-trial basis.
TSR and XML distribution
Trial owners can access TSR and XML documents.
How to Display Trial Ownership
1. On the toolbar, click Administration > Trial Ownership > View.
The Display Trial Ownership page displays the current owner(s) of the trials for which your organization is the lead organization. It also
indicates which of the owners, for each of the trials, will receive system-generated email notifications.

2. To display all the trials owned by a given user, search for the user by first name, last name, or email address, and then click Search.
All trials owned by the user are listed in the Search Results list.
3. To display all owners of a given trial, enter the NCI Identifier in the field provided, and then click Search.
All owners of the selected trial are listed in the Search Results list.
You can filter the search results and create more space to display the results
To filter the search results, in the Search field, type one or more characters contained in any of the fields. The list is filtered as
you type subsequent characters. For details, refer to Working with Tables and Search Results.
To create more space on the page, on the upper right corner of the page, select the Hide Search Criteria check box.
4. To indicate whether or not an owner of a trial should receive system-generated email messages, in the Receive Email? column, select Y
es or No.
Selecting Yes indicates that the owner will receive all notifications regarding the specified trial.
Selecting No indicates that the owner will not receive any notifications regarding the specified trial.
5. To revoke ownership of a trial, locate the user/trial in the Search Results list, and then click Remove.
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Adding Sites

As a site administrator, you can add participating sites as follows:

Add your site to multiple Abbreviated trials
Add a Family Member Organization as a participating site to multiple Abbreviated trials
Add multiple Family Member Participating Sites to a given trial
The system does not allow duplicate sites on trials.
How to Search for the Trials to which You Want to Add Participating Sites
1. On the toolbar, click Register Trial > Add Sites.
The Search Trials page appears.

2. Enter the NCI, Lead Organization, or Other trial identifier; or, enter all or part of the Trial Title.
3. Click Search.
The Abbreviated trials with which your affiliated organization or its family members are not yet participating are listed in the results table.
The system can return up to 100 trials. If the system finds over 100 records in the database, it will prompt you to narrow your
search criteria.

4. Optionally, to sort the results, click the column ascending or descending arrows. This option only is available prior to adding your first site.
How to Add Organizations as Participating
1. On the toolbar, click Register Trial > Add Sites, and search for the trials to which you can add participating sites as per the previous
topic.
The Abbreviated trials with which your affiliated organization or its family members are not yet participating are listed in the results table.
2. Click the Plus sign (

) to add participating sites to a trial.

The trial record expands to display trial information. The Site field is pre-populated with your affiliated organization automatically.

3. If you need to change the participating site, select one from the Site drop-down list. Only your family member organizations are listed.
4.
5.
6.
7.
8.
9.

If the Principal Investigator has not been selected, click the Look Up Person icon (
) and search for the investigator.
Enter the Local Trial Identifier.
Optionally, in the Program Code field, enter a program code for the site.
Select the Current Recruitment Status and the Current Recruitment Status Date.
Optionally, select the Date Opened for Accrual and Date Closed for Accrual.
To add another site to the same trial, in the Site column, click Add Another Site, and repeat the steps above to complete the trial/site

9.
information.
10. Scroll to the bottom of the page and click Save.

Verifying Trial Data v4.3
Verifying Trial Data v4.3
NCI requires that trial owners, trial submitters, and members of the Clinical Trials Reporting Office (CTRO) staff verify their open trial records
twice per year to ensure that information is accurate and up-to-date.
This requirement applies to Interventional trials that have the following attributes:
Trial processing status is either Abstraction Verified - No Response or Abstraction Verified - Response
Trial status is anything other than the following:
Withdrawn
Administratively Complete
Complete
CTRO staffs are responsible for verifying the types of trials below. Trial owners and submitters are responsible for verifying all others.
NCI-managed trials (trials with DCP or CTEP IDs)
NCI-sponsored trials
Trials imported from ClinicalTrials.gov
Trials submitted by users affiliated with the National Cancer Institute or National Cancer Institute Division of Cancer Prevention
Trials submitted by the NCI Center for Cancer Research (CCR)
The system sends trial owners, trial submitters, and site administrators a verification reminder 30 and 15 days before their trial data verification
due dates. It sends reminders to CTRO staffs 7 days before the due date.
Each time you verify a trial, the CTRP system records your name and date of verification. This is true for original as well as updated trials. You
can view these records at any time, but cannot change them.
How to Access the Trial Data Verification Page
1. Search for the trial by the identifier noted in the email reminder you received, or use the Search My Trials feature.
2. In the Available Actions column, click Select Action > Verify Data.

The Trial Data Verification page appears.

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

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

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

Working With Persons and Organizations v4.3
Working With Persons and Organizations v4.3

Topic Links
Looking up Registered
Organizations
Adding Organizations to the CTRP
Looking Up Registered Persons
Adding Persons to the CTRP
This section provides instructions for looking up persons and organizations registered in the Clinical Trials Reporting Program (CTRP), and for
adding new persons and organizations to it.

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

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

3. Click Search.
The search results appear in a new tab.

If the lead organization is not listed, you may have searched too narrowly (that is, you may have provided too much information about the
organization). If the list of results is very long and contains many organizations that are similar to the one you are searching for, you can
narrow your search by providing more information.
If the organization does not appear in the results table, do one of the following to modify your search:
a. To broaden your search so that more organizations are listed in the search results, delete one or more of your criteria. For
example, if you searched by part of the organization’s name, city, state, and zip code in your original search, you may want to
search by state alone.
-or b. To narrow your search so that fewer organizations are listed in the search results, provide more about your organization. For
example, if you searched by state in your original search, you may want to search by city in addition to the state.
If you still don’t find your organization in the system, you can add it using the Add Org feature.
c. To control which columns appear in your search results, click Choose Columns.
A list of the available columns appear. Clear the check boxes for those columns you do not want to display.

4. To link to an organization to the trial, click its PO-ID value.
The organization’s name you selected appears in the Family Name field.
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Adding Organizations to the CTRP
If you are unable to find an organization, you can add a Lead Organization, Data Table 4 Funding Sponsor, etc. when you register, update, or
amend a trial .
Check for duplicate organizations first
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.
When you register an organization, the CTRO staff curate the organization's record, then add it to the list of registered organizations in the CTRP.
The procedure below uses the Lead Organization as an example. The same fields may not appear in all Add Organization windows
however.
How to Add Organizations to the CTRP
1. Hover your mouse over any field for an organization, such as Please Select the Lead Organization.
A list of organizations appears.

2. At the bottom of the list, click Search.
The Select Lead Organization page (or Select Sponsor page, if you started there) appears.

3. Click Add Org.
The Add Organization window appears.

4. In the Organization Name field, type the full name of the organization.
5. Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field.
ZIP Codes are required for organizations in the USA, Canada, and Australia.
6. Click Save.
The organization you added is saved in the system and is displayed in a table at the bottom of the page.
7. In the organization record, click Select.
The Organization Name field is populated with the organization you just added.
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Looking Up Registered Persons
The procedure for searching for the name of a person registered in the Clinical Trials Reporting Program is the same throughout the application,
whether you are searching for principal investigators, responsible parties, or other roles. To link a person to a role, you select the person's record
from a list of search results.
The procedure below uses the principal investigator role as an example. The same search criteria may not appear in all search
windows however.

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

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

Tip
If your principal investigator is not listed, you may have searched too narrowly (that is, you may have provided too much
information about the person). If the list of results is very long and contains many names that are similar to the one you are

searching for, you can narrow your search by providing more information. Refer to the Step below for instructions.
4. If your investigator was not listed, modify your search as follows:
To broaden your search so that more names are listed in the search results, delete one or more of your criteria. For example, if
you searched by both first and last names in your original search, you may want to search by last name alone.
- or To narrow your search so that fewer names are listed in the search results, provide more information about your investigator. For
example, if you searched by last name only in your original search, you may want to search by first name as well.
Tip
If you still don't find your investigator in the system, you can add the person.
5. To associate a person with the role, scroll through the results list until you locate the principal investigator's record, and then click Select.
The investigator's name you selected appears in the Principal Investigator field.
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Adding Persons to the CTRP
f you are unable to find a person, you can add one when you register, update, or amend a trial .
Check for duplicate names first
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.
When you register a person, the CTRO staff curate the person's record, then add it to the list of registered persons in CTRP.
The procedure below uses the principal investigator role on the Register Trial page as an example. The same fields may not appear in
all Add Person windows however.
How to Add Persons to CTRP
1. Next to any field for person, such as Principal Investigator, click Look Up Person.
The Select Principal Investigator window appears.

2. Click Add Person. The Add Person window appears.

3. Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field. Use
professional contact information only. For U.S. and Canadian contacts, type phone and fax numbers in the format xxx-xxx-xxxx. For all
others, you can use spaces or dashes as separators, or no separators at all. Include phone number extensions where applicable.
Privacy concerns
The information you provide is not revealed to the public.

ZIP Codes are required for organizations in the USA, Canada, and Australia.
4. Click Save.
Avoid creating duplicate records
To prevent creating a duplicate record, do not click Save more than once. If you have to make changes after you click Save, do
not use your browser’s back button to make changes, and submit the record again. Instead, contact the CTRO.
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.
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Viewing Trial Summary Reports and XML Documents v4.3
Viewing Trial Summary Reports and XML Documents v4.3

This section provides instructions for viewing Trial Summary Reports (TSRs) and XML documents. XML documents are available for trials that

have been designated for import into ClinicalTrials.gov.
You can view the Trial Summary Report (TSR) for Complete trials you own.
The View TSR link is available even if the CTRO has not accepted the trial.
You can view the XML document for a trial you own if it meets the following criteria:
Trial category is Complete
Processing status is one of the following:
Abstraction Verified Response
Abstraction Verified No Response
On Hold (if the trial was put on hold after it reached either of the two statuses above)
XML Required, Enable "Upload from NCI CTRP in ClinicalTrials.gov?" indicator is Yes

How to View TSR and XML Documents
1. Search for the trial(s) for which you want to view a TSR or XML document.
The Submitted Clinical Trials Search Results table displays the trial(s) you searched for. Available actions are listed (if any) for each
record.

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

Managing Your Account v4.3
Managing Your Account v4.3

Topic Links
Resetting Your NCI Password
Retrieving Your Username
Managing Your User Account
Profile
This section provides instructions for resetting and modifying your CTRP account.

Resetting Your NCI Password
How to Reset Your NCI Password
Navigate to the NCI Password Station at http://password.nci.nih.gov. Once you have logged in to the NCI Password Station, use the Cha
nge Password feature to create a new password.
- or On the Registration login page, click Forgot Your Password?.
A pop-up window provides instructions for resetting your password and a link to the NCI Password Station.

Retrieving Your Username

How to Retrieve Your Username
1. On the Login Page, click the Forgot Your Username? link.
The Retrieve User Name page is displayed.
2. Enter the email address associated with your account, and click Submit.
The system sends your username to the email address you provided.
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Managing Your User Account Profile
You can update your account information after you have registered for an account and have logged in to Registration.
Changing your Organizational Affiliation results in loss of privileges
If you change your organizational affiliation, the system revokes your existing Site Admin and Accrual Submission privileges.
How to Edit Your Account Information
1. On the top right corner of any page, click Your Username > My Account.
The My Account page appears, populated with the information you previously supplied for your account.
2. In the Your Account Profile section, make any changes as necessary, and then click Save.
Keep your account up to date
The PRS organization name is required for uploading trial records to ClinicalTrials.gov via a system-generated file. The PRS
organization name you include in your profile is included in that file. This precludes having to update the PRS name in the file.
Therefore it is very important for you to update your account whenever there is a change in PRS.

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Using CTRP Registration Templates v4.3
Using CTRP Registration Templates v4.3

Topic Links
Downloading Trial Registration
Templates
Using the Complete Trial
Participating Sites Template
Main Steps for Submitting
Your Complete Trial
Participating Sites Data
Preparing Participating
Sites Data Files
Trial
Requirements
Data Specification
Requirements
Submitting Participating
Sites Files
This section provides instructions for submitting multiple trials in batches.
The CTRP provides templates and other resources on their website, and on the CTRP Batch Trial Template page, that you can use to facilitate
trial information gathering and registration. See Registering Multiple Complete Trials in Batch Files . You can also use the templates to update
and amend Complete trials that you have registered previously. 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 themselves.

Downloading Trial Registration Templates
You can download the following templates (MS Excel files) for Complete trials directly from the CTRP Trial Registration Batch File Templates pag
e, or from the CTRP website:
CTRP Registration Complete Batch Upload Template. Use this template as a guide to record trial data required for registering multiple
interventional Complete trials, updates, and amendments in batches. See Registering Multiple Complete Trials in Batch Files .
CTRP Registration Complete Participating Sites Template. Use this template to record interventional trial 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.
For information about trial updates and amendments, see About Trial Amendments and About Trial Updates .
How to Download CTRP Trial Registration Templates
1. Navigate to the CTRP Trial Registration Batch File Templates page.
2. Click the link for the appropriate template.
3. Follow your browser/operating system instructions to view or save the document.
If you have difficulty locating or downloading the templates, send a request for the files to application support at ncicbiit@mail.nih.gov.
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Using the Complete Trial Participating Sites Template
The participating sites template is designed for recording additional participating site and collaborator data for interventional trials, especially if
site-specific data is not included in the trial protocol.
Main Steps for Submitting Your Complete Trial Participating Sites Data

How to Submit Your Complete Trial Participating Sites Data
1. Prepare the trial data file. See Preparing Participating Sites Data Files.
2. Upload the file via the trial-related document feature in Registration. See Submitting Participating Sites Files.
The .xls file that contains the trial data you want to register must meet certain requirements for successful registration. Ensure
that you use this template for single complete interventional trials only.
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Preparing Participating Sites Data Files

To ensure successful submission, ensure that your trials conform to the following criteria:
Study Type

Complete
Interventional only

Data Table 4 Funding Sponsor Categories

National
Externally Peer-Reviewed
Institutional

Processing Statuses for Trial Amendments

Abstraction Verified Response
Abstraction Verified No Response

Processing Statuses for Trial Updates

Accepted and beyond

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Data Specification Requirements

The Participating Sites template includes data element requirements, valid values, rules and examples for registering complete trial participating
site and collaborator information.
How to Prepare Complete Trial Participating Sites Data Files
1. Download the Complete Trial Participating Sites Template (Excel spreadsheet). See Downloading Trial Registration Templates .
2. Enter the trial data elements as specified in the template.
The .xls file that contains the trial data you want to register must meet certain requirements for successful registration as listed
below and in the template itself.
You must adhere to the following requirements:
List trial elements required for registration in the order specified in the template.
Do not change the spelling of data elements or valid values.
Conform to the valid values guidelines when entering trial data.
Identify each trial uniquely.
Participating site information must include the following data elements:
Study participating site data
At least one study site investigator's information
Participating site primary or central contact information. Generic contact information is accepted.
Organization attribute
Current recruitment status
Status date
Target accrual. This is mandatory if the target accrual is for a study at a participating site or if the lead organization is an
NCI-designated Cancer Center.
Optionally, provide a local trial identifier.
Study site investigator's information must include the following data elements:
Study site investigator data with person's attributes
Investigator's role in the study at the site
When registering multiple investigators for a single trial, create one line per investigator/site, using the participating site
number as reference.
Participating site contact information is optional if the contact person is the investigator, or if the central contact information is provided.
List persons and organizations with PO-IDs.
You can request a list of CTRP persons and organizations along with PO-IDs from the CTRO at ncictro@mail.nih.gov.
Or, you can use the organization/person look-up features in Registration to search for PO-IDs.

Program Code Updates
Although you can update Program Codes via Registration, you can not do so via the Participating Sites batch template.

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Submitting Participating Sites Files

You can submit the data file when you register your trial via Registration.

How to Submit Complete Trial Participating Sites Files
1. In Microsoft Excel, list the trial elements required for registration in the order specified in the template. To access the template, see Downl
oading Trial Registration Templates .
2. Once you have completed the template, upload it via the Trial Related Documents section on the Register Trial page in Registration.
For upload instructions, see Recording Trial-Related Documents.
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Viewing Trial-Related Documents v4.3
Viewing Trial-Related Documents v4.3
This section provides instructions for accessing and viewing trial documents.
Trial-related documents include, but are not limited to the following types:
Complete Protocol document
IRB Approval
List of Participating Sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact
information.
Informed Consent
Only trial owners and administrators can view/download trial-related documents.
How to Download Trial-Related Documents
1. Click the NCI Trial Identifier link associated with the trial of interest.
The metadata for the selected trial is displayed in a new page.
2. In the section at the bottom of the page, click the link associated with the document of interest.
A dialog box appears in which you are given the option to open the document or save it to a location of your choice.
3. Follow your browser/operating system instructions to view or save the document.
If a trial has been updated or amended, there is likely to be more than one (1) Trial Summary Report (TSR) listed. You can view and
download each of them separately. To access Trial Summary Reports and XML documents, see Viewing Trial Summary Reports and
XML Documents.

Working with Tables and Search Results v4.3
Working with Tables and Search Results v4.3
The system lists search results in tables. You can navigate through the records in several ways, and choose which columns are of interest to you.
Additionally, you can filter the results by typing a string of characters in a search field.
To do this...

Do this...

Move horizontally across the page

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

Sort your results by column

Click the Sort icons

Move to the first page of results

Click <<

Move to the previous page of results

Click < or click the preceding page number

Move to the next page of results

Click > or click the next page number

Move to the last page of results

Click >>

Move to a specific page of results

Click a specific page number

Choose how many rows you want to
display per page

Select the number of rows from the Show selector

Choose which columns to display

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

Search the list of results by keywords

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

Export search results to a file

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

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

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

CTRP Trial Categories (Study Sources) v4.3
CTRP Trial Categories (Study Sources) v4.3
Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category (study source). Refer to http://cancercenters.ca
ncer.gov/GrantsFunding/DataGuide#dt4 for further information.
Complete Trials:
National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism
supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems.
Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing

scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center
investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting
results.
It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial
should clearly be the intellectual product of the center investigator.
This category may also include:
Institutional studies authored and implemented by investigators at another Center in which your Center is
participating.
Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and
externally peer-reviewed studies should be listed with those categories, not as Institutional studies.)
Abbreviated Trials:
Industrial/Other: A pharmaceutical company controls the design and implementation of these clinical research studies.

NCI Division and Program Codes v4.3
NCI Division and Program Codes v4.3

Division/Program Code

Definition

CCR

Center for Cancer Research

CCT/CTB

Center for Cancer Training/Cancer Training Branch

CDP

Cancer Diagnosis Program

CIP

Cancer Imaging Program

CTEP

Cancer Therapy Evaluation Program

DCB

Division of Cancer Biology

DCCPS

Division of Cancer Control and Population Sciences

DCEG

Division of Cancer Epidemiology and Genetics

DCP

Division of Cancer Prevention

DEA

Division of Extramural Activities

DTP

Developmental Therapeutics Program

Office of the Director, NCI, NIH

OSB/SPORE

Organ Systems Branch/Specialized Programs of Research Excellence

RRP

Radiation Research Program

TRP

Translational Research

N/A

Not applicable

NIH Institution Codes v4.3
NIH Institution Codes v4.3

Valid Value

Definition

NEI

National Eye Institute

NHLBI

National Heart, Lung, and Blood Institute

NHGRI

National Human Genome Research Institute

NIA

National Institute on Aging

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIAID

National Institute of Allergy and Infectious Diseases

NIAMS

National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIBIB

National Institute of Biomedical Imaging and Bioengineering

NICHD

Eunice Kennedy Shriver National Institute of Child Health and Human Development

NIDCD

National Institute on Deafness and Other Communication Disorders

NIDCR

National Institute of Dental and Craniofacial Research

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases

NIDA

National Institute on Drug Abuse

NIEHS

National Institute of Environmental Health Sciences

NIGMS

National Institute of General Medical Sciences

NIMH

National Institute of Mental Health

NINDS

National Institute of Neurological Disorders and Stroke

NINR

National Institute of Nursing Research

NLM

National Library of Medicine

CIT

Center for Information Technology

CSR

Center for Scientific Review

FIC

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

NCCAM

National Center for Complementary and Alternative Medicine

NCMHD

National Center on Minority Health and Health Disparities

NCRR

National Center for Research Resources (NCRR

NIH Clinical Center

Office of the Director

NIH Grant Institute Codes v4.3
NIH Grant Institute Codes v4.3

Code

Organization

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Office of the Assistant Secretary for Planning and Evaluation

Administration for Children and Families

National Institute on Aging (NIA)

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

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

NIAID Research Support

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

National Center for Complementary and Integrative Health (NCCIH)

Division of Basic Sciences (NCI)

Biomedical Laboratory Research and Development

National Cancer Institute (NCI)

Division of Cancer Biology and Diagnosis (NCI)

Office of the Director, Centers for Disease Control and Prevention

National Center for Injury Prevention and Control

Coordinating Center for Infectious Diseases

National Center for Infectious Diseases (NCID)

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

Clinical Center (CLC)

Division of Cancer Treatment (NCI)

Division of Cancer Prevention and Control (NCI)

Office of the Director (NCI)

Division of Cancer Epidemiology and Genetics (NCI)

Cooperative Research and Development Agreements (NCI)

Center for Information Technology (CIT)

Cooperative Studies Program

Clinical Science Research and Development

National Institute on Drug Abuse (NIDA)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Centers for Disease Control and Prevention

National Institute of Dental and Craniofacial Research (NIDCR)

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

National Center for Chronic Disease Prevention and Health Promotion

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Center for Environmental Health

Environmental Health Services

Epidemiology Program Office

National Institute of Environmental Health Sciences (NIEHS)

National Eye Institute (NEI)

Food and Drug Administration

Office of Genomics and Disease Prevention

Coordinating Office of Global Health

National Institute of General Medical Sciences (NIGMS)

Genome Association Studies (GAS)

Division of Blood Diseases and Resources (NHLBI)

Division of Epidemiology and Clinical Applications (NHLBI)

National Institute of Child Health and Human Development (NICHD)

National Human Genome Research Institute (NHGRI)

Division of Intramural Research (NHLBI)

Office of National Center for Public Health Informatics

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Health Marketing

Office of the Director (NHLBI)

Health Resources and Services Administration / Bureau of Health Professions

Division of Lung Diseases (NHLBI)

Agency for Healthcare Research and Quality

Division of Heart and Vascular Diseases (NHLBI)

Health Services Research and Development

Office of Health and Safety

National Center for Immunization and Respiratory Diseases

Joint Funding

National Library of Medicine (NLM)

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Mental Health (NIMH)

Office of Minority Health

Neuroscience Blueprint (NB)

National Institutes of Health

National Institute of Nursing Research (NINR)

National Institute of Neurological Disorders and Stroke (NINDS)

Division of Nursing

Office of the Administrator (SAMHSA)

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

Office of the Director (NIH)

Office of Research Facilities Development and Operations (ORFDO)

National Institute for Occupational Safety and Health

Office of Logistics and Acquisition Operations (OLAO)

Office of Research Services (ORS)

Division of Cancer Control and Population Science (NCI)

Public Health Practice Program Office

Office of Chief Public Health Practice

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

Center for Cancer Research (CCR)

Office of Research and Development

Center for Scientific Review (CSR)

NIH Roadmap Initiative, Office of the Director (RMOD)

National Center for Research Resources (NCRR)

Rehabilitation Research and Development

Division of Clinical Sciences (NCI)

Superfund Basic Research Program (SBRP)

National Center for Health Statistics

Center for Mental Health Services

Center for Substance Abuse Prevention

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

Coordinating Office for Terrorism Preparedness and Emergency Response

National Center for Advancing Translational Sciences (NCATS)

Agency for Toxic Substances and Disease Registry

John E. Fogarty International Center (FIC)

Veterans Affairs

Office of Workforce and Career Development

Women's Health Initiative (WHI, OD)

Worker Education Training Program (WETP)

Trial Phase Value Definitions v4.3
Trial Phase Value Definitions v4.3
0 - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, micro dose
studies). See FDA guidance on exploratory IND studies for more information.
I - Includes initial studies to determine the metabolism and pharmacologic actions of a medical approach in humans, the side effects
associated with increasing doses or exposure, and to gain early evidence of effectiveness; may include healthy participants and/or
patients.
I/II - Includes trials that are a combination of phases I and II.
II - Includes controlled clinical studies conducted to evaluate the effectiveness of the medical approach for a particular indication or
indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
II/III - Trials that are a combination of phases II and III.
III - Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the medical approach has
been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide
an adequate basis for physician labeling.
IV - Studies of FDA-approved drugs, interventions, tests or diagnostic procedures to delineate additional information including the medical
approach risks, benefits, and optimal use.
NA (Not applicable) - All non-interventional or pilot studies.

Trial Processing Statuses v4.3
Trial Processing Statuses v4.3
This section provides the definitions of each of the statuses that occur during the course of the trial processing work flow. It also illustrates the
work flow so that you can see the relationships between the trial statuses.
Trial Processing
Status

Definition

All

Any processing status.

Submitted

Original trial submitted but not validated.

Amendment
Submitted

Amendment submitted but not validated.

Accepted

Trial passed validation.

Rejected

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

Abstracted

Trial has been abstracted.

Verification
Pending

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

Abstraction
Verified
Response

Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days
after receiving the TSR.

Abstraction
Verified No
Response

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

On-Hold

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

Submission
Terminated

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

Submission
Reactivated

Trial processing has resumed in PA.

(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of
Personnel Management's list of Federal Holidays.)

Milestone Workflow

Trial Registration Funding Mechanism Codes v4.3
Trial Registration Funding Mechanism Codes v4.3
Funding
Mechanism
Code

Funding Mechanism Name

B01

Preventive Health Services

B08

Substance Abuse Prevention and Treatment Block Grant

B09

Mental Health Services Block Grant

C06

Research Facilities Construction Grant

D43

International Training Grants in Epidemiology

D71

International Training Program Planning Grant

DP1

NIH Director's Pioneer Award (NDPA)

DP2

NIH Director's New Innovator Awards

DP3

Type 1 Diabetes Targeted Research Award

E11

Grants for Public Health Special Projects

F05

International Research Fellowships (FIC)

F30

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

F31

Predoctoral Individual National Research Service Award

F32

Postdoctoral Individual National Research Service Award

F33

National Research Service Awards for Senior Fellows

F34

MARC (NRSA) Faculty Fellowships

F37

Medical Informatics Fellowships

F38

Applied Medical Informatics Fellowships

G07

Resources Improvement Grant

G08

Resources Project Grant (NLM)

G11

Extramural Associate Research Development Award (EARDA)

G12

Research Centers in Minority Institutions Award

G13

Health Sciences Publication Support Awards (NLM)

G20

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

G94

Administrative Support for Public Health Service Agency Foundations

H13

Conferences

H23

Immunization Program

H25

Venereal Disease Control

H28

State and Community-Based Injury Control Programs

H50

Maternal and Child Health Services Project, RB Funds

H57

Indian Health Service Loan Repayment Program

H62

Services or Education on AIDS

H64

State and Community-Based Childhood Lead Poisoning Prevention Program

H75

Health Investigations/Assessments of Control/Preven. Methods

H79

Mental Health and/or Substance Abuse Services Grants

HD4

Drug Use/Alcohol Abuse Prevention Demo: Community Partnership Study

HR1

State Mental Health and Substance Abuse Data Resource Projects

HS5

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

I01

Non-DHHS Research Projects

K01

Research Scientist Development Award - Research & Training

K02

Research Scientist Development Award - Research

K05

Research Scientist Award

K06

Research Career Awards

K07

Academic/Teacher Award (ATA)

K08

Clinical Investigator Award (CIA)

K12

Physician Scientist Award (Program) (PSA)

K14

Minority School Faculty Development Awards

K18

The Career Enhancement Award

K21

Scientist Development Award

K22

Career Transition Award

K23

Mentored Patient-Oriented Research Career Development Award

K24

Midcareer Investigator Award in Patient-Oriented Research

K25

Mentored Quantitative Research Career Development Award

K26

Midcareer Investigator Award in Biomedical and Behavioral Research

K30

Clinical Research Curriculum Award (CRCA)

K99

Career Transition Award

KD1

Mental Health and/or Substance Abuse KD&A Grants

KL1

Linked Research Career Development Award

KL2

Mentored Career Development Award

KM1

Institutional Career Enhancement Awards - Multi-Yr Funding

L30

Loan Repayment Program for Clinical Researchers

L32

Loan Repayment Program for Clinical Researchers from Disadvantaged Backgrounds

L40

Loan Repayment Program for Pediatric Research

L50

Loan Repayment Program for Contraception and Infertility Research

L60

Loan Repayment Program for Health Disparities Research

M01

General Clinical Research Centers Program

N01

Research and Development Contracts

N02

Resource and Support Contracts - Awarded in the ICD

N03

Station Support Contracts - Awarded by the Division of Procurement

N43

Small Business Innovation Research - Phase I (Contract)

N44

Small Business Innovation Research - Phase II (Contract)

P01

Research Program Projects

P20

Exploratory Grants

P30

Center Core Grants

P40

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

P41

Biotechnology Resource Grants

P42

Hazardous Substances Basic Research Grants Program (NIEHS)

P50

Specialized Center

P51

Primate Research Center Grants (NCRR)

P60

Comprehensive Center

P76

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

PL1

Linked Center Core Grant

PN1

Concept Development Award

PN2

Research Development Center

R00

Research Transition Award

R01

Research Project

R03

Small Research Grants

R04

Anthrop. Fellow Res. Support (old

R06

Translations

R08

Development of Innovative Technology for Measurement of Lead

R13

Conference

R15

Academic Research Enhancement Awards (AREA)

R17

Mental Health Career Investigator Grants Active

R18

Research Demonstration and Dissemination Projects

R21

Exploratory/Developmental Grants

R24

Resource-Related Research Projects

R25

Education Projects

R30

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

R33

Exploratory/Developmental Grants Phase II

R34

Clinical Trial Planning Grant

R36

Dissertation Award

R37

Method to Extend Research in Time (MERIT) Award

R41

Small Business Technology Transfer (STTR) Grants - Phase I

R42

Small Business Technology Transfer (STTR) Grants - Phase II

R43

Small Business Innovation Research Grants (SBIR) - Phase I

R44

Small Business Innovation Research Grants (SBIR) - Phase II

R49

Injury Control Research and Demonstration Projects and Injury Prevention Research Centers

R55

James A. Shannon Director's Award

R56

High Priority, Short Term Project Award

R90

Interdisciplinary Regular Research Training Award

RC1

NIH Challenge Grants and Partnerships Program

RC2

High Impact Research and Research Infrastructure Programs

RC3

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

RC4

High Impact Research and Research Infrastructure Programs Multi Year Funding

RL1

Linked Research project Grant

RL2

Linked Exploratory/Development Grant

RL5

Linked Education Project

RL9

Linked Research Training Award

RS1

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

S06

Minority Biomedical Research Support - MBRS

S10

Biomedical Research Support Shared Instrumentation Grants (NCRR)

S11

Minority Biomedical Research Support Thematic Project Grants

S21

Research and Institutional Resources Health Disparities Endowment Grants -Capacity Building

S22

Research and Student Resources Health Disparities Endowment Grants - Educational Programs

SC1

Research Enhancement Award

SC2

Pilot Research Project

SC3

Research Continuance Award

T01

Graduate Training Program

T02

Undergraduate Training Program

T03

Combined Undergraduate and Graduate Training Program

T06

Minority Supplements to Clinical Training Grants

T09

Scientific Evaluation

T14

Conferences

T15

Continuing Education Training Grants

T32

Institutional National Research Service Award

T34

MARC Undergraduate NRSA Institutional Grants

T35

NRSA Short -Term Research Training

T36

MARC Ancillary Training Activities (Grant) (NIGMS)

T37

Minority International Research Training Grants (FIC)

T42

Educational Resource Center Training Grants

T90

Interdisciplinary Research Training Award

TL1

Linked Training Award

TU2

Institutional National Research Service Award with Involvement of NIH Intramural Faculty

U01

Research Project--Cooperative Agreements

U09

Scientific Review and Evaluation--Cooperative Agreements

U10

Cooperative Clinical Research--Cooperative Agreements

U11

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

U13

Conference--Cooperative Agreements

U14

Public Health Leadership Institute Cooperative Agreement

U17

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

U18

Research Demonstration--Cooperative Agreements

U19

Research Program--Cooperative Agreements

U1A

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

U1Q

Emergency Disaster Relief Relating to CDC Programs Cooperative Agreement

U1S

Emergency Disaster Relief Relating to SAMHSA Programs Cooperative Agreements

U1T

Violence Prevention Training for Minority Medical Students Cooperative Agreement

U1V

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

U21

Immunization Service for Racial and Ethnic Minorities, Cooperative Agreements

U22

HIV/STD Preventive Services for Racial and Minorities

U23

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

U24

Resource-Related Research Related Cooperative Agreements

U27

Surveillance of Complications of Hemophilia Cooperative Agreements

U2G

Global HIV/AIDS Non-Research Cooperative Agreements

U2R

International Training Cooperative Agreement

U30

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

U32

State-based Diabetes Control Programs

U34

Clinical Planning Grant Cooperative Agreement

U36

Program Improvements for Schools of Public Health

U38

Uniform National Health Program Reporting System

U41

Biotechnology Resource Cooperative Agreements

U42

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

U43

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

U44

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

U45

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

U47

Laboratory/Other Diagnostic Medical Quality Improvement Cooperative Agreements

U48

Health Promotion and Disease Prevention Research Centers

U49

Coop: Injury Control Res. and Demo and Injury Prevention

U50

Special Cooperative Investigations/Assessment of Control/Prevention Methods

U51

Health Planning Strategies/National Academy of Sciences Activities

U52

Cooperative Agreement for Tuberculosis Control

U53

Capacity Bldg: Occupational Safety/Community Environmental Health

U54

Specialized Center--Cooperative Agreements

U55

Core Support For American Council on Transplantation Active

U56

Exploratory Grants--Cooperative Agreements

U57

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

U58

Chronic Disease Control Cooperative Agreement

U59

Disabilities Prevention Cooperative Agreement Program

U60

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

U61

Preventive Health Activities Regarding Hazardous Substances

U62

Prevention/Surveillance Activities/Studies of AIDS

U65

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

U66

Immunization Demonstration Projects Cooperative Agreements

U75

National Cancer Registries Cooperative Agreements

U79

Mental Health and/or Substance Abuse Services Cooperative Agreements

U81

Injury Community Demonstration Projects: Evaluation of Youth Violence Prevention Program

U82

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

U83

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

U84

Cooperative Agreements for Fetal Alcohol Syndrome Prevention Research Programs

U87

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

U88

Services Demonstration Cooperative Agreements

U90

Cooperative Agreements for Special Projects of National Significance (SPNS)

UA1

AIDS Research Project Cooperative Agreement

UC1

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

UC2

High Impact Research and Research Infrastructure Cooperative Agreement Programs

UC3

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

UC6

Construction Cooperative Agreement

UC7

National Biocontainment Laboratory Operation Cooperative Agreement

UD1

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

UE1

Studies of Environmental Hazards and Health Effects

UE2

Emergency and Environmental Health Services

UH1

HBCU Research Scientist Award

UH2

Exploratory/Developmental Cooperative Agreement Phase I

UH3

Exploratory/Developmental Cooperative Agreement Phase II

UL1

Linked Specialized Center Cooperative Agreement

UR1

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

UR3

School Health: Findings from Evaluated Programs Cooperative Agreements

UR6

Prevention Intervention Research on Substance Abuse in Children Cooperative Agreements

UR8

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

US3

Hantaviral Reservoir Studies Cooperative Agreements

US4

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

UT1

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

UT2

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

VF1

Rape Prevention and Education Grants

X01

Resource Access Award

X02

Preapplication

X06

Projects for Assistance in Transition from Homelessness

X98

Protection and Advocacy for Mentally Ill Individuals

Y01

NIH Inter-Agency Agreements

Y02

NIH Intra-Agency Agreements

Z01

Intramural Research

Z02

Intramural Research Resources

Z1A

Investigator-Initiated Intramural Research Projects

Trial Status Date Rules in the CTRP v4.3
Trial Status Date Rules in the CTRP v4.3
Valid dates for a given trial status depend on the other values you have entered, and whether those dates are Actual (current, or past) or Anticipat
ed (future).
The following diagram illustrates these rules. The arrow at the top of the diagram represents a time line for the life of a trial. The three horizontal
bands in the lower section of the diagram represent, from top to bottom, the relative date (actual or anticipated) rules for trial Start Date types,
Primary Completion Date types, and Completion Date types.

The following table provides the rules for trial status dates as diagrammed.
Rules for Status/Dates relationships
If this is true...

Follow this rule

Current Trial Status is anything other than In Review, Approved, or
Withdrawn

Trial Start Date must be Actual (solid band)

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated (diagonal stripes
band)

Current Trial Status is Complete

All date types must be Actual (solid band)

Trial Status Transition Rules in the CTRP v4.3
Trial Status Transition Rules in the CTRP v4.3
The table and diagram below provide rules for ensuring that you record valid transitions between trial statuses.
Trial Status Flow Relationships
A trial can proceed from this
status…
In Review

Directly to this status

Approved
Withdrawn

Or to this status

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

Approved

Active/Enrolling by
Invitation
Withdrawn

Active/Enrolling by Invitation

Closed to Accrual

Closed to Accrual and
Intervention

Completed
Administratively
Completed

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

Temporarily Closed to Accrual

Temporarily Closed to Accrual
and Intervention

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

Temporarily Closed to Accrual
and Intervention

Administratively Completed

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

Trial Status Transitions

Trial Status Values in the CTRP and ClinicalTrials.gov v4.3
Trial Status Values in the CTRP and ClinicalTrials.gov v4.3
This section maps each of the CTRP trial status values to their counterparts in ClinicalTrials.gov.
Trial status refers to the current stage or state of a clinical trial relative to other stages and its ability to enroll participants/patients.
Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values as listed in the table below.
Current trial status definitions
CTRP Trial
Status Values

ClinicalTrials.gov
Trial Status
Values

Definition

In Review

Not yet recruiting

Trial is currently under IRB review.

Withdrawn

Trial has been withdrawn from development and review prior to enrollment of the first participant.

Approved

Not yet recruiting

Trial has been approved, but is not yet recruiting or enrolling participants.

Active

Recruiting

Trial is open for accrual and enrollment.

Enrolling by
Invitation

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

Temporarily
Closed to Accrual

Suspended

Participant recruitment or enrollment has been halted prematurely but may resume. Participants
already on trial continue to receive intervention.

Temporarily
Closed to Accrual
and Intervention

Suspended

Participant recruitment or enrollment has been halted prematurely but may resume. Participants
already on trial do not receive intervention.

Closed to Accrual

Active, not
recruiting

Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive
treatment and/or examination).

Closed to Accrual
and Intervention

Active, not
recruiting

Trial has been closed to participant accrual. Participants already on trial do not receive treatment,
but continue to be monitored for endpoints such as long term survival.

Administratively
Complete

Terminated

Participant recruitment or enrollment has been halted prematurely (for example, due to poor accrual,
insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the trial do
not receive further treatment or examination.

Complete

Completed

Trial has been closed to accrual and follow-up. Participant treatment/intervention has been
completed and participants are no longer monitored for trial endpoints (i.e., last patient's visit has
occurred). The trial has met its objectives.

Trial Summary Report and XML File Data Elements v4.3
Topic Links
TSR-XML Data Element
Comparisons
Trial Summary Report Data
Elements by Section
Trial Identification Data
Elements
General Trial Details
Status/Dates
Regulatory
Information/Oversight
Information
Human Subject
Safety/Regulatory
Authority
NIH Grants
Data Table 4 Information
Collaborators
Disease/Condition
Trial Design
Eligibility Criteria
Intervention(s)/Intervention
(s)
Arm and Group(s)
Primary and Secondary
Outcome Measures
Participating Sites
Excerpts from Example TSR and
Example XML File
The CTRP system captures the trial data you submit, and from them generates two types of trial documents: a Trial Summary Report (TSR),
formatted for user consumption; and an XML file formatted for upload to ClinicalTrials.gov. Both documents contain a subset of trial data elements
captured in the CTRP. However, the TSR contains more elements than the XML because ClinicalTrials.gov-required fields are different from
those in CTRP. Some data that appear in the TSR do not appear in the XML, and vice versa. The documents are described below.
Trial Summary Report (TSR) – Report that presents a summary of key abstracted data from the trial you registered, in an easy-to-read
format. The CTRP system sends the TSR as an attachment in an email to the trial submitter/owner with instructions to review the TSR for
accuracy and to report any changes to the CTRO staff.
When a trial has been amended, the system sends a modified TSR to the submitter that reflects the changes.

XML File – File that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. This document is sent only to trial
submitters/owners who indicated that an XML file is required for submission to ClinicalTrials.gov when they registered the trial.
The following sections compare the TSR data elements with those in the XML.

TSR-XML Data Element Comparisons

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If you don't see all four columns in the table below, scroll down to the bottom of the table and use the horizontal scroll bar to display
them.

Data Fields

Sample TSR Data

Sample Corresponding XML Data

Record
Verification Date

2013-03

<verification_date>2013-03</verification_date>

Trial Category

Complete

Not included in the XML file

Trial Type

Interventional

<study_type>Interventional</study_type>

NCI Trial Identifier

NCI-2011-9999

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

ClinicalTrials.gov
Identifier

NCT01234567

Not included in the XML file

Lead
Organization
Identifier

CCCCWFU 12345

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

DCP Identifier

WFU-01-01-06

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

CTEP Identifier

WFU-01-01-06

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

CCR Identifier

CCR-123

Not included in the XML file

Amendment Date

02/10/2003

Not included in the XML file

Amendment
Number

Not included in the XML file

Type

Interventional

<study_type>Interventional</study_type>

Official Title

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

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

Brief Title

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

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

Acronym

ABC

Not included in the XML file

Brief Summary

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

<brief_summary><textblock>
This clinical trial is studying how well Armodafinil works..../>
<textblock><brief_summary>

Detailed
Description

Detailed Description...

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

Primary
Objectives

I. To estimate....

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

Secondary
Objectives

I. To obtain a preliminary
estimate....

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

Outline

OUTLINE: This is a multicenter
study....

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

Keywords

Feasibility Armodafinil;
narcolepsy

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

Reporting Dataset
Method

Complete

Not included in the XML file

Sponsor

National Cancer Institute

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

Lead
Organization

Wake Forest University Health
Sciences

<overall_official>
<first_name>PI First Name</first_name>
<last_name>PI Last Name</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences </affiliation>
</overall_official>

Principal
Investigator

Autissier, Isabelle affiliated
with Wake Forest University
Health Sciences in the role of
Principal Investigator

<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>

Responsible Party Sponsor

<resp_party_type>Sponsor</resp_party_type>

Overall Official

Autissier, Isabelle affiliated
with Wake Forest University
Health Sciences in the role of
Principal Investigator

<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>National Cancer Institute External</affiliation>
</overall_official>

Current Trial
Status

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

<overall_status>Active, not recruiting</overall_status>

Trial Start Date

08/01/2010-Actual

<start_date>2010-08</start_date>

Primary
Completion Date

01/11/2014-Actual

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

Completion Date

02/04/2014-Actual

<last_follow_up_date>2014-02</last_follow_up_date>
If no data are available, the "<last_follow_up_date>" does not appear in the XML file.

Oversight
Authorities

United States: Food and Drug
Administration

<oversight_info>
<regulatory_authority>United States : Food and Drug Administration</regulator
</oversight_info>

FDA Regulated
Intervention?

Yes

<is_fda_regulated>Yes</is_fda_regulated>

Section 801?

Yes

<is_section_801>Yes</is_section_801>

DMC Appointed?

No Data Available

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

IND/IDE Study?

Yes

<is_ind_study>Yes</is_ind_study>

Board Approval
Status

Submitted, approved

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

Board Approval
Number

IRB00012856

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

Board

Wake Forest University Health
Sciences

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

Affiliation

Wake Forest University Health
Sciences

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

IND/IDE > Type

IND

<ind_info>

IND/IDE >
Grantor

CBER

<ind_grantor>CBER</ind_grantor>

IND/IDE >
Number

119999

<ind_number>119999</ind_number>

IND/IDE > Holder
Type

NCI

Not included in the XML file

IND/IDE >
Expanded Access

Yes

<has_expanded_access>Available</has_expanded_access>

IND/IDE
Expanded Access
Status

Not included in the TSR

Not included in the XML file

IND/IDE >
Exempt Indicator

Not included in the XML file

NIH Grants >
Funding
Mechanism

U10

<secondary_id><id>U10CA12345</id><id_type>NIH Grant
Number</id_type></secondary_id><secondary_id>

NIH Grants > NIH
Institution Code

<secondary_id>
<id>U10CA 012345</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NIH Grants >
Serial Number

88888

<secondary_id>
<id>U10CA8888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NIH Grants > NCI
Division/Program
Code

DCP

Not included in the XML file

Data Table 4
Information >
Funding Category

Externally Peer-Reviewed

Not included in the XML file

Data Table 4
Information >
Funding
Sponsor/Source

National Cancer Institute

Not included in the XML file

Anatomic Site
Code

Prostate

Not included in the XML file

Collaborator
Name

National Cancer Institute

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

Collaborator Role

Funding Source

Not included in the XML file

Disease/Condition Prostate Carcinoma
Name

<condition>Prostate Carcinoma</condition>

Trial Design >
Type

<study_type>Interventional</study_type>
and

Interventional

<study_design>Interventional</study_design>
Trial Design >
Primary Purpose

Prevention

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

Trial Design >
Phase

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

Trial Design >
Intervention
Model

Parallel

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

Trial Design >
Number of Arms

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

Trial Design >
Masking

Double Blind

<study_design>
<interventional_design>
<masking>Double Blind</masking>
</interventional_design>
</study_design>

Trial Design >
Allocation

Randomized Controlled Trial

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

Trial Design >
Classification

Safety/Efficacy

<study_design>
<interventional_design>
<endpoint>Safety Efficacy Study</endpoint>
</interventional_design>
</study_design>

Trial Design >
Target Enrollment

100

Eligibility Criteria
> Accepts Healthy
Volunteers?

Eligibility Criteria
> Gender

Both

Eligibility Criteria
> Minimum Age

18 Years

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

Eligibility Criteria
> Maximum Age

N/A

Eligibility Criteria
> Inclusion
Criteria

Family history of prostate
cancer...

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

Eligibility Criteria
> Exclusion
Criteria

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

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

Intervention(s) >
Type

Drug

<intervention_type>Drug</intervention_type>

Intervention(s) >
Name

Armodafinil

<intervention_name>Armodafinil</intervention_name>

Intervention(s) >
Alternate Name

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

Intervention(s) >
Description

Given orally

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

Arm/Group(s) >
Type

Placebo Comparator

<arm_type>Placebo Comparator</arm_type>

Arm/Group(s) >
Label

Arm II

<arm_group_label>Arm II</arm_group_label>

Arm/Group(s) >
Description

Patients receive oral
Armodafinil once daily....

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

Primary Outcome
Measures > Title

Accrual rate estimated as the
number of patients ....

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

Primary Outcome
Measures >
Description

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

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

Primary Outcome
Measures > Time
Frame

Up to 2 years

<outcome_time_frame>Up to 2 years</outcome_time_frame>

Secondary
Outcome
Measures > Title

Incidence of toxicity
incidents....

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

Secondary
Outcome
Measures >
Description

<outcome_description>

Secondary
Outcome
Measures > Time
Frame

Up to 2 years

<outcome_time_frame>Up to 2 years</outcome_time_frame>

Secondary
Outcome
Measures >
Safety Issue?

<outcome_safety_issue>No</outcome_safety_issue>

Sub-groups
Stratification
Criteria > Label

Not included in the TSR

Not included in the XML file

Sub-groups
Stratification
Criteria >
Description

Not included in the TSR

Not included in the XML file

Markers > Marker
Name

Not included in the TSR

Not included in the XML file

Markers >
Evaluation Type

Not included in the TSR

Not included in the XML file

Markers > Assay
Type

Not included in the TSR

Not included in the XML file

Markers >
Biomarker Use

Not included in the TSR

Not included in the XML file

Markers >
Biomarker
Purpose

Not included in the TSR

Not included in the XML file

Markers >
Specimen Type

Not included in the TSR

Not included in the XML file

Participating Sites
> Facility

Wake Forest University Health
Sciences

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

Winston-Salem, NC 27106
United States

Participating Sites
> Contact

Autissier, Isabelle, M.
phone:123-123-1234
Email:ia@domain.com

<location>
<contact>
<first_name>Isabelle</first_name>.<middle_name>M</middle_name><last_name>Auti
<phone>123-123-1234></phone>
<email>ia@domain.com</email>..
</ contact>
</location>

Participating Sites
> Recruitment
Status and Dates

Enrolling by Invitation as of
05/09/2014

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

Participating Sites
> Target Accrual

Not included in the XML file

Participating Sites
> Investigators

Autissier, Isabelle, Principal
Investigator

<investigator>
<first_name>Isabelle</first_name><last_name>Autissier</last_name><role>Princi
Investigator</role>
</investigator>

Trial Summary Report Data Elements by Section
Each of the following sections contain mapping tables, in the order in which they appear in the TSRs.
Trial Identification Data Elements

TSR Data Elements

XML Data Elements

Trial Category

Not included in the XML file

Trial Type

<study_type>

NCI Trial ID

<secondary_id><id>

Other Trial ID

<id_type>

Organization ID

<org_study_id>

ClinicalTrials.gov ID

Not included in the XML file

Amendment Date

Not included in the XML file

Amendment Number

Not included in the XML file

General Trial Details

TSR Data Elements

XML Data Elements

Study Type

<study_type>

Official Title

<official_title>

Brief Title

<brief_title>

Acronym

Brief Summary

<brief_summary>

Detailed Description

<detailed_description>

Keywords

Reporting Dataset Method

Not included in the XML file

Sponsor

<lead_sponsor>

Lead Organization

<overall_official>

Principle Investigator

<resp_party>

Responsible Party

<resp_party_type>

Overall Official

<overall_official>

Status/Dates

TSR Data Elements

XML Data Elements

Current Trial Status

<overall_status>

Trial Start Date

<start_date>

Primary Completion Date

primary_compl_date>primary_compl_date_type>

Completion Date

<last_follow_up_date>

Regulatory Information/Oversight Information

TSR Data Elements

XML Data Elements

Oversight Authorities

<oversight_info>

FDA Regulated Intervention?

<is_fda_regulated>

Delayed Posting Indicator?

<delayed_posting>

Section 801?

<is_section_801>

DMC Appointed?

<has_dmc>

IND/IDE Study?

<is_ind_study>

Human Subject Safety/Regulatory Authority

TSR Data Elements

XML Data Elements

Board Approval Status

<approval_status>

Board Approval Number

<approval_number>

Board

<irb_info>

Affiliation

NIH Grants

TSR Data Elements

XML Data Elements

Funding Mechanism

<secondary_id>

NIH Institute Code

<secondary_id>

Serial Number

<secondary_id>

NCI Division/Program Code

<secondary_id>

Data Table 4 Information

TSR Data Elements

XML Data Elements

Funding Category

Not included in the XML file

Funding Sponsor/Source

Not included in the XML file

Anatomic Site Code

Not included in the XML file

Collaborators

TSR Data Elements

XML Data Elements

Collaborator Name

Role

Not included in the XML file

Disease/Condition

TSR Data Elements

XML Data Elements

Disease/Condition Name

Trial Design

TSR Data Elements

XML Data Elements

Type

<study_type>

Primary Purpose

<interventional_subtype>

Phase

<phase>

Intervention Model

Number of Arms

<number_of_arms>

Masking

Allocation

Classification

Target Enrollment

Eligibility Criteria

TSR Data Elements

XML Data Elements

Accepts Healthy Volunteers?

<healthy_volunteers>

Gender

Minimum Age

<minimum_age>

Maximum Age

<maximum_age>

Inclusion Criteria

Exclusion Criteria

Intervention(s)/Intervention(s)

TSR Data Elements

XML Data Elements

Type

<intervention_type>

Name

<intervention_name>

Alternate Name

<intervention_other_name>

Description

<intervention_description>

Arm and Group(s)

TSR Data Elements

XML Data Elements

Number of arms

Not included in the XML file

Primary and Secondary Outcome Measures

TSR Data Elements

XML Data Elements

Title

<outcome_measure>

Description

<outcome_description>

Time Frame

<outcome_time_frame>

Safety Issue?

<outcome_safety_issue>

Participating Sites

TSR Data Elements

XML Data Elements

Facility

Contact

Recruitment Status and Dates

Target Accrual

Not included in the XML file

Investigator(s)

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

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

</pre><Table class="table"><tr><Td>File Type</td><td>application/pdf</td></tr><tr><Td>File Modified</td><td>2016-01-21</td></tr><tr><Td>File Created</td><td>2016-01-21</td></tr></table></div></div></div><hr>
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