Attach_6_CTRP-Registration-UsersGuide

1. NCI Clinical Trials Reporting Program Registration Site User's Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 1 - Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 About the CTRP Registration Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2 What's New in This Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3 About Clinical Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4 Creating CTRP Registration Site Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4.1 Creating New CTRP Registration Site Accounts Using NIH or NCI Credentials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4.2 Creating New CTRP Registration Site Accounts via Email . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5 Requesting Organization Admin Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.6 Logging In to the CTRP Registration Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 2 - Searching for Trials, Organizations, and Persons in the CTRP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1 Searching for Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2 Searching for Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.3 Searching for Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.4 Working with Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.5 Viewing Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.6 Viewing Trial-Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.7 Exporting Search Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 3 - Registering New Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.1 Main Steps for Registering Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.2 Recording Trial Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.3 Recording Trial Identification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.4 Recording Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.5 Recording Lead Organizations and Principal Investigators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.6 Recording Sponsors and Responsible Parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.7 Recording Summary 4 Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.8 Recording NIH Grant Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.9 Recording Trial Statuses and Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.10 Recording Site Recruitment Statuses and Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.10.1 Trial Status Rules for Start and Primary Completion Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.11 Recording IND and IDE Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.12 Recording Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.13 Recording Trial-Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.14 Editing Trial Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.15 Printing Trial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.16 Completing and Deleting Saved Drafts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.17 Registering Multiple Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.17.1 Registering Multiple Complete Trials in Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.17.2 Registering Multiple Abbreviated Trials in Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 4 - Updating Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.1 About Trial Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2 Updating Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.3 Reviewing and Submitting Trial Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.4 Editing Updated Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.5 Printing Updated Trial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.6 Changing Trial Status Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 5 - Amending Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.1 About Trial Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.2 Amendment Process Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.3 Amending Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.4 Reviewing and Submitting Trial Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.5 Editing Amended Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.6 Printing Amended Trial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 6 - Adding Your Site to Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 7 - Managing Participating Site Record Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8 8 - Managing Site Administration Within Your Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.1 Granting and Revoking Administrative Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.9 9 - Displaying Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.10 10 - Managing Trial Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11 11 - Managing Access to Subject Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11.1 Assigning and Un-Assigning Subject Accrual Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11.2 Viewing Accrual Assignment History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11.3 Viewing Accrual Assignment History by Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.12 12 - Managing Your Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.12.1 Resetting Your NCI Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.12.2 Retrieving Your Username . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.12.3 Managing Your User Account Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.13 13 - Using CTRP Registration Templates and Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.13.1 Downloading Trial Registration Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.13.2 Using the Complete Trial Participating Sites Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.13.3 Using the Abbreviated Trial Participating Sites Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.13.4 Using the Abbreviated Trial Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.14 A - Working With Persons and Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.14.1 Looking Up Registered Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.14.2 Adding Persons to CTRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.14.3 Looking Up Registered Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.14.4 Adding Organizations to CTRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.15 B - Common Tasks and Data Element Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.15.1 Navigating Search Results Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.15.2 Requesting Trial Summary Reports and XML Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.15.3 Selecting and Entering Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.15.4 Entering Phone and Fax Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.16 C - Funding Mechanism Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.17 D - Institute Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.18 E - NCI Division and Program Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.19 F - Trial Processing Statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.20 G - Trial Phase Value Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.21 H - Trial Summary Reports and XML Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.22 I - Clinical Trial Summary 4 Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.23 CTRP Registration Credits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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NCI Clinical Trials Reporting Program Registration Site
User's Guide
NCI Clinical Trials Reporting Program Registration Site User's
Guide
Contents of this Page
About this Guide
Audience
Topics Covered
Application Support
CTRP Registration Links
NCI Clinical Trials Registration Site
Overview of CTRP Applications
Templates for batch trial or accrual submissions
CTRP Registration Site video tutorials
CTRP Resources
CTRP Issue Tracker (JIRA) (Login required)
CTRP Website
Dictionary of cancer terms
Terminology resources

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Application Support
If you have problems with the program or have suggestions for any of the CTRP User 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 the NCI Clinical Trials Reporting Program Trial Registration Site (CTRP
Registration Site) and instructions for using its tools and resources to search for and view details of existing clinical
trials. Additionally, users can submit new clinical trials and amend and/or update those currently registered and

verified in the CTRP.

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

Topics Covered
If you are new to NCI Clinical Trials Reporting Program Trial Registration Site, read this brief overview, which
explains what you will find in each chapter and appendix.
1 - Getting Started introduces you to the CTRP Registration Site and provides instructions for registering for
an account and for logging in to the system.
2 - Searching for Trials, Organizations, and Persons in the CTRP System provides instructions for searching
for existing trials, persons, and organizations that have been registered the CTRP system.
3 - Registering New Trials describes how to register, Institutional, National, and Externally Peer-Reviewed
trials using the CTRP Registration Site. It also provides instructions for registering multiple trials in batches.
4 - Updating Trials describes how to update complete and abbreviated trials that are currently registered and
verified in CTRP.
5 - Amending Trials describes how to submit amendments to complete trials currently registered and verified
in the CTRP.
6 - Adding Your Site to Abbreviated Trials provides instructions for adding your organization as a participating
site to Industrial (abbreviated) trials.
7 - Managing Participating Site Record Ownership provides instructions for assigning and un-assigning
participating site record ownership to other registered CTRP users from your organization for abbreviated
trials in which your organization is a participant.
8 - Managing Site Administration Within Your Organization introduces you to site administration management
and provides instructions for granting and revoking administrative authority.
9 - Displaying Trial Ownership provides instructions for site administrator to view trial ownership.
10 - Managing Trial Ownership provides instructions for managing trial ownership.
11 - Managing Access to Subject Accruals provides instructions for assigning and un-assigning access to the
Subject Accruals application.
12 - Managing Your Account provides instructions for modifying your CTRP Registration Site account.
13 - Using CTRP Registration Templates and Resources provides instructions for submitting participating site
information for complete and abbreviated trials; and disease/condition and intervention information for
abbreviated trials.
A - Working With Persons and Organizations provides instructions for looking up persons and organizations
registered in the CTRP system, and for adding new persons and organizations to it.
B - Common Tasks and Data Element Formats provides detailed instructions for tasks that are common to
many of the procedures for recording trial information in the Clinical Trials Reporting Program (CTRP). It also
provides a key to the user interface (icons, buttons, etc.) and valid formats for entering information such as
dates and phone numbers.
C - Funding Mechanism Codes provides the values for funding mechanism codes, the NCI codes used to
identify areas of extramural research activity applied to various funding mechanisms.
D - Institute Codes provides the values for institute codes, the NCI codes used to identify the name of the
primary organization responsible for funding the trial.
E - NCI Division and Program Codes provides the values for Division codes, the NCI codes used to identify
the name of the NCI Division responsible for a grant.
F - Trial Processing Statuses provides definitions for 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.
G - Trial Phase Value Definitions provides definitions for each of the trial phases.

H - Trial Summary Reports and XML Files provides definitions and examples of the system-generated Trial
Summary Report and XML files.
I - Clinical Trial Summary 4 Categories provides definitions of CTRP trial categories.

Application Support
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 as per the instructions below.
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

1 - Getting Started
1 - Getting Started
This section introduces you to the NCI Clinical Trials Reporting Program Trial Registration Site (CTRP Registration
Site) and provides instructions for registering for an account and logging in to the system. It also provides
information for accessing templates and other resources.
This section includes the following topics:
About the CTRP Registration Site
What's New in This Release
About Clinical Trial Details
Creating CTRP Registration Site Accounts
Requesting Organization Admin Rights
Logging In to the CTRP Registration Site
Browser Support
This version of the application supports Firefox 14.0.1, and Internet Explorer 8. Although tested
on these browsers alone, CTRP applications should work with all popular browsers. However, if
you use another browser to access CTRP applications, you may experience problems.

About the CTRP Registration Site
About the CTRP Registration Site
The CTRP Registration Site provides cancer clinical trial access to researchers who have Clinical Trials Reporting
Program (CTRP) accounts. It enables these users to view details of existing trials submitted by members of the
cancer research community, and to register, amend, and update trials one-at-a-time or in batches consisting of
multiple trials. Currently you can register complete and abbreviated interventional trials. Future releases of this
product will enable you to register observational, ancillary, and correlative studies as well.

Related Topics
About Clinical Trial Details
Accessing Registered Trials

What's New in This Release
What's New in This Release
This version of the CTRP Registration Site has the following new features and improvements:
Accrual Access Management
You can now assign and un-assign access to the CTRP Subject Accrual application to users in your
organization
Email Messages and Trial Ownership
Email messages that are sent to trial owners who have updated or amended their trials contain details
of the changed elements
You can now indicate whether a user would like to receive system notifications, including TSRs and
XML files, on a trial-by-trial basis
Navigation and User Interface Improvements
A "Back to Search Results" button enables you to return to your search results after leaving the Search
Results page
Person and Organization Search Features and Improvements
You can now search for organizations and persons by their PO IDs

About Clinical Trial Details
About Clinical Trial Details
The CTRP Registration Site captures clinical trial details, a sanctioned set of key data elements, entered into the
system by trial protocol submitters. This set of recorded data enables the research community to share and analyze
standardized clinical trial details.
Tip
The glossary on the CTRP web site at http://www.cancer.gov/clinicaltrials/ctrp/page12 provides
definitions, attributes, and examples of metadata associated with trials.

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).

Creating CTRP Registration Site Accounts
Creating CTRP Registration Site Accounts
To search for and submit individual clinical trial protocol details, you must have an NIH (or NCI) account and a
Clinical Trials Reporting Program account. You can create both types of accounts using the Registration

application's account creation feature. The way in which you create a new account in the CTRP Registration Site
depends on whether you have a current NIH account, as follows:
If you are a new user AND you do not have an NIH account, request one via the CTRP Registration Site.
Follow the instructions in Creating New CTRP Registration Site Accounts via Email.
If you are a new user AND you have an NIH account, use your current credentials to register for a CTRP
account via the CTRP Registration Site. Follow the instructions in Creating New CTRP Registration Site
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.

Creating New CTRP Registration Site Accounts Using NIH or NCI Credentials
Creating New CTRP Registration Site Accounts Using NIH or NCI Credentials

Although you already have an NIH (or NCI) account, you
must register for an associated CTRP Registration Site
account. The CTRP account identifies your organization
affiliation, whether or not you own a particular trial, and
other such details specific to the NCI Clinical Trials
Reporting Program Trial Registration Site.
How to Create New CTRP Registration Site Accounts Using NIH Credentials
1. Navigate to the CTRP Registration Site home page at http://trials.nci.nih.gov/registration.
2. Click Create an account.
The Register for a CTRP Account page appears.

Register for a CTRP Account Page
3. Because you already have an NIH account, click the here link.
The Register for a CTRP Account page displays username and password fields.

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

My Account Page
5. Select or enter the appropriate information in the text fields and drop-down lists in Your Account Profile.
Fields with an asterisk (*) are required.
Privacy concerns
Contact information is required for internal administrative use only. Your information is not
revealed to the public.

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 Persons. Once
organization affiliation is assigned, 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 access. Otherwise
the View Admins link that enables you to display
the name of the current admins appears. (The link
appears only if the organization you are affiliated
with already has one or more registered admins.)

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.

Submit

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

Contact information is required for internal administrative use only. Your information is not
revealed to the public.

Related Topics

Creating CTRP Registration Site Accounts
Logging In to the CTRP Registration Site

Creating New CTRP Registration Site Accounts via Email
Creating New CTRP Registration Site Accounts via Email
If you are new to the NCI Clinical Trials Reporting Program Trial Registration Site and you do not have an NCI
account, request a CTRP Registration Site account via the CTRP Registration Site account creation feature.

How to Create a New CTRP Registration Site Account
1. Navigate to the CTRP Registration Site home page at http://trials.nci.nih.gov/registration.
2. Click Create an account.
The Register for a CTRP Account page appears.

Register for a CTRP Account Page
3. In the Email Address field, type the email address you will use for registering trials (this should be your
business email address), and then click Next.
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 ncicb@
pop.nci.nih.gov or by calling 888-478-4423.
4. Open the account information email when it arrives, and click the embedded link to the My Account page.
The My Account page appears, pre-populated with the email address you provided.

My Account Page--Your Account Profile
5. Select or enter the appropriate information in the text fields and drop-down lists in Your Account Profile.
Fields with an asterisk (*) are required.
Privacy concerns
Contact information is required for internal administrative use only. Your information is not
revealed to the public.

Field Name

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 Persons. Once
organization affiliation is assigned, 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 access. Otherwise
the View Admins link that enables you to display
the name of the current admins appears. (The link
appears only if the organization you are affiliated
with already has one or more registered admins.)

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.

Submit

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

Requesting Organization Admin Rights
Requesting Organization Admin Rights
You can request Admin rights for your affiliated organization to take advantage of the following features:

Site Administration - Enables you to accept or reject requests for Admin rights from other users within your
organization.
Trial Ownership management - Enables you to assign and un-assign ownership of your organization's trials to
other registered users within your organization.
Condition
The Request for Admin Access check-box on the My Account page is displayed if no one in
your organization has been granted administrative (admin) access.

How to Request Admin Access
Do one of the following on the My Account page to request admin access:
Select the Request for Admin Access check box, and then click Submit.
-orClick the View Admins link, and contact one of the current Affiliated Organization Administrators to request
admin aceess.
The CTRO will send you an email message when your request has been approved or rejected. If
approved, you can access all trials for your affiliated organization, review and update trial
ownership, and assign new administrator status to other users in your organization.

Logging In to the CTRP Registration Site
Logging In to the CTRP Registration Site
Once you have created a CTRP Registration Site account, you can log in to search for and submit clinical trial
details.
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 also 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 NCICB Support at ncicb@pop.nci.nih.go
v , or phone: 301-451-4384 or toll free: 888-478-4423. If you have forgotten your password, see
Resetting Your NCI Password.

How to Log In to the CTRP Registration Site
1. Navigate to the CTRP Registration Site home page at http://trials.nci.nih.gov/registration.
2. On the Home page, click the Log In link.
You can also display the Login page by clicking Log In on the navigation pane on the left
side of the page or on the banner at the top of the page on the right side.

The Login page appears.

CTRP Registration Site – Login page
3. Type your username and password in the fields provided. If you do not have a registered username and
password, see Creating CTRP Registration Site Accounts. If you have forgotten your password or username,
or have been locked out of your account, see the instructions in Managing Your Account.
4. Click Log In.
The notification regarding respondent burden appears.
5. After you read the public reporting burden notice, click Accept.
The Search Trials page appears.
6. After you have logged in to CTRP Registration Site, you can proceed to search for and/or add clinical trials in
the system.
Related Topics
Searching for Trials
Registering New Trials

2 - Searching for Trials, Organizations, and Persons in the CTRP
System
2 - Searching for Trials, Organizations, and Persons in the CTRP System
The CTRP Registration Site enables you to search for trials, persons, and organizations that have been registered
with the CTRP system. In each case you are presented with a pre-defined set of search criteria that is appropriate
for the type of search you are conducting. For example, when you search for a trial, the set of criteria includes Title,
Trial Phase, and Purpose, whereas a set of criteria for searching for a person will include Last name and First
Name.
All criteria are presented as fields in which you type attributes, or as drop-down lists from which
you select them. You can run your search once you have selected or typed an attribute for at
least one criterion.

This section includes the following topics:
Searching for Trials
Searching for Organizations
Searching for Persons
Working with Search Results
Viewing Trial Details
Viewing Trial-Related Documents
Exporting Search Results
Related Topics

Working With Persons and Organizations
About Clinical Trial Details

Searching for Trials
Searching for Trials
You can retrieve existing interventional trials once you have registered for an account. See Creating CTRP
Registration Site 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 have submitted or 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.
Use the Search On Hold Trials to search for trials that the CTRO has placed on hold.
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 All Trials

Types of Trials Returned

All trials

Search My Trials
Trials on hold
Trials for which you are
the trial submitter or
owner

Search Saved Drafts
Partial Submissions

Actions Permitted

View Trial Details
Add/Update My Site
(Abbreviated trials only)
If
you
are
the
trial
sub
mitte
r or
own
er of
a
trial
in
the
sear
ch
resul
ts,
you
can
perf
orm
the
sam
e
actio
ns
as
you
woul
d
whe
n
usin
g
the
Sear
ch
My
Trial
s fe
atur
e.

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

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 trials that you registered or own which have not been validated.
These trials are indicated by the "Submitted" status.

How to Search for Existing Trials
1. On the navigation pane on the left side of the page, click Search Clinical Trials.
The Search Trials page appears.

Search Clinical Trials Page
2. Select or enter the appropriate information in the text fields and drop-down lists 1 Fields are described in the
following table.
Tip
If you are searching for a saved draft, search by Phase, Purpose, Title, or Identifier only.
Because the system adds wildcards for you, do not type wildcard symbols in the search
fields.

Trial Search Criteria
To search by this...

Do this...

Title

Type one or more words from the long title or name
of the trial provided by the principal investigator or
sponsor.
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.
See Trial Phase Value Definitions.
* Phase 0
* Phase I
* Phase I/II
* Phase II
* Phase II/III
* Phase III
* Phase IV
* N/A

Pilot Trial?

If the trial is a pilot, select Yes.

Purpose

Select the primary purpose of the trial from the
drop-down menu.
* Treatment
* Prevention
* Supportive Care
* Screening
* Diagnostic
* Health Services Research
* Basic Science
* Other – Any other type of trial not included in this
list

Identifier Type

Select the type of trial identifier from the drop-down
list.
* NCI – NIH National Cancer Institute identifier
* NCT (Exact Match) – National Clinical Trial
identifier (NCT Number). Provide the exact number,
including the NCT prefix. Example: NCT00012345
* Lead Organization – Type the unique identifier
assigned to the trial by the lead organization.
* Other identifier
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

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

Organization Type

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

Organization

Type the initial letter(s) of your organization and
then select the name of your organization from the
drop-down list.
To search for trials by
organization without having to
specify what role the
organization plays in the trial,
select Either or Both from the O
rganization Type list, and then
select the name of the
organization of interest.

Principal Investigator

Type the initial letter(s) of the principal investigator's
last name and then select the investigator's name
from the drop-down list

Search by Trial Category

To restrict your search by trial category, select Abbr
eviated or Complete from the drop-down list.
Otherwise, select Both.

3. Do one of the following:

3.
To search all registered trials in the system, click Search All Trials.
-orTo search only the trials that you submitted or own, click Search My Trials. This feature enables
access to all the trials that you have submitted, including those that are currently on hold 1
-orTo search only the trials that you have saved for later completion, click Search Saved Drafts.
-orTo clear all search criteria and begin a new search, click Reset.
The Search Trials page refreshes and displays a list of search results. For more information on navigating
and working with search results, see Navigating Search Results Lists.
4. To view the trial, click the link corresponding to the NCI Trial Identifier.
The Trial Details page appears. For more information on viewing trial details, see Viewing Trial Details.
Tip
You can create more space on your monitor for the search results list by hiding the search fields.
To do so, select the Hide Search Fields check box at the top left side of the search criteria
section.

null
Related Topics
Working with Search Results
Adding Organizations as Participating Sites to Registered Industrial Trials
Searching for Organizations
Searching for Persons
Exporting Search Results

Searching for Organizations
Searching for Organizations
You can search for organizations that are currently registered with the Clinical Trials Reporting Program.
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. On the navigation pane, click Search Organizations.
The Search Organizations window appears.

Search Organizations Window
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 type 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 (%) between characters of the string as necessary..
3. Click Search.
The Search Organizations window displays the results of your search.

Search Organizations Window – 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 an email link
that you can use to contact the organization.

Organization Details Window

Searching for Persons
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 Look Up Registered Persons
1. On the navigation pane, click Search Persons.
The Search Persons window appears.

Search Persons Window
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 type 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 (%) between characters of the string as necessary..
3. Click Search.
The Search Persons window displays the results of your search.

Search Persons Window – 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.

4.

- 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.

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

Working with Search Results
Working with 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 a status of "accepted," and the system
notifies the site 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 a status
of "rejected," and the system sends the submitter an email message indicating the status and reason for the
rejection.
Reviewers may also reject a trial for the following reasons:
CTEP/DCP/CCR has approved the trial. NCI transfers these trials internally.
The trial is non-interventional. Non-interventional trials will be supported in future releases.
If you have questions about a rejected trial, contact the CTRO at
ncictro@nih.nci.gov.

The trials that match your search criteria are listed in the Submitted Clinical Trials Search Results table. 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 illustrated 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 the CTRP
Registration Site
Public trials – Trials submitted by other registered users
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.

Search Results Table - Columns on the Left Side

Search Results Table - Columns on the Right Side
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. Column headers in bold italic text below indicate the information that is
displayed for Public trials.
NCI Trial Identifier – Unique identifier assigned to the trial by the CTRP
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, usually an accession number or a variation of a grant number. Multiple studies conducted under
the same grant must each have a unique number.
Principal Investigator – Appointed investigator responsible for conducting clinical trial, or for multi-site trials,
the study chair
NCT Number - Number assigned to the trial by PRS (ClinicalTrials.gov) (for trials that have been submitted to
ClinicalTrials.gov previously.
Other Identifiers_ - Identifiers other than Lead Organization Trial Identifier or NCT Number
Current Trial Status – 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 - 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). The documents are sent via email to all trial
owners
The actions available for a trial depend on its processing status and participating
site record ownership.
Participating Sites - One or more organizations participating in the trial. Click View in the Participating
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 - Summary 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
Summary 4 Funding 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 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:
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.

Related Topics
Navigating Search Results Lists
Exporting Search Results

Viewing Trial Details
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 hypert
ext link.
The details provided for a given trial depend on trial ownership (private or public) and Summary 4 Category (complet
e 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.

Related Topics
Viewing Trial Details
Searching for Trials, Organizations, and Persons in the CTRP System
Navigating Search Results Lists

Viewing Trial-Related Documents

Viewing Trial-Related Documents
Only trial owners and system 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 the instructions for your browser and operating system 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.

Related Topics
Viewing Trial Details
Working with Search Results

Exporting Search Results
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 table, 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. Open or save the file.

3 - Registering New Trials
3 - Registering New Trials
This section describes how to register new National, Externally Peer-Reviewed and Institutional interventional
protocols (collectively referred to as complete trials), and Industrial trials, (referred to as abbreviated trials), in the
CTRP system.
This section includes the following topics.
Main Steps for Registering Trials
Recording Trial Identifiers

Recording Trial Identification Information
Recording Trial Details
Recording Lead Organizations and Principal Investigators
Recording Sponsors and Responsible Parties
Recording Summary 4 Information
Recording NIH Grant Information
Recording Trial Statuses and Dates
Recording Site Recruitment Statuses and Dates
Recording IND and IDE Information
Recording Regulatory Information
Recording Trial-Related Documents
Editing Trial Details
Printing Trial Information
Completing and Deleting Saved Drafts
Registering Multiple Trials

Main Steps for Registering Trials
Main Steps for Registering Trials
The CTRP Registration Site provides a user-friendly interface through which you can register and update complete
and abbreviated trials. Additionally, it enables you to amend complete interventional protocols in the CTRP system.
Complete. Trials in this category include the following types of interventional trials:
National. National Cooperative Group Trials. These trials are conducted by the following cooperative
groups:
American College of Radiology Imaging Network
American College of Surgeons Oncology Group
Cancer and Leukemia Group B
Children’s Oncology Group
Eastern Cooperative Oncology Group
European Organization for Research and Treatment of Cancer
Gynecologic Oncology Group
National Cancer Institute of Canada, Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Southwest Oncology Group
Externally Peer-Reviewed. R01s and P01s or other trial mechanisms funded by NIH or supported by
other peer-reviewed funding organizations.
In-house trials authored or co-authored by cancer center investigators and undergoing scientific
peer-review solely by the Protocol Review and Monitoring System of the Center. The center
investigator should have primary responsibility for conceptualizing, designing and implementing the
trial and reporting results. It is acceptable for industry and other entities to provide some support (e.g.,
drug, devices, other funding) but the trial should clearly be the intellectual product of the center
investigator.
Abbreviated. Trials in this category are Industrial trials. The design and implementation of these studies is
controlled by the pharmaceutical company.

Check for duplicate trials first
Before you begin to register a trial, ensure that the trial does not exist in the system already. You
can do this by searching for trials using any of the criteria as per the instructions in Searching for
Trials. The system uses the Lead Organization ID, Lead Organization Trial ID, and the NCT
number to detect duplicates. If a duplicate is detected, the system will not record your trial.

How to Register New Trials
1. On the navigation pane on the left side of the page, click Register Trial.
The Select Trial Submission Category window appears.

Select a Trial Submission Category Window
2. Trials are categorized by Summary 4 Trial Submission Category. Select National, Externally
Peer-Reviewed, Institutional, or Industrial, and then click Submit.
The Register Trial page appears. Information displayed on the Register Trial page differs according to the
category of trial you selected.

Register Trial Page – Complete Trials, Upper Section
For complete trials, 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.
3. 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 CTRP Registration Site 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 trials
Field Label

Description/Instructions

XML required for ClinicalTrials.gov? (complete
trials only)

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 will dictate which other
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:
* Recording Trial Identifiers (complete trials)
* Recording Trial Identification Information (abbrevia
ted trials)
* Recording Trial Details (complete and abbreviated
trials)
* Recording Lead Organizations and Principal
Investigators (complete trials)
* Recording Sponsors and Responsible Parties
* Recording Summary 4 Information for NIH-Funded
Trials (complete and abbreviated trials)
* Recording NIH Grant Information (complete trials)
* Recording Trial Statuses and Dates (complete
trials)
* Recording Site Recruitment Statuses and Dates (a
bbreviated trials)
* Recording IND and IDE Information (complete
trials)
* Recording Regulatory Information (complete trials)
* Recording Trial-Related Documents (complete
and abbreviated trials)

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 CTRP Registration Site
and retrieve your draft later to complete the
registration. The system stores the draft for 30 days.

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 Recording Trial Details.

4. Correct any errors if indicated, and repeat the previous steps as many times as necessary until the trial is
error-free.
5. To continue with the trial registration, scroll to the bottom of the Review Trial Details page, and then click Su
bmit. 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

5.

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.

Related Topics
Printing Trial Information
Completing and Deleting Saved Drafts
Registering Multiple Trials in a Batch

Recording Trial Identifiers
Recording Trial Identifiers
This section pertains to complete trials only. You must provide a Lead Organization trial identifier for each trial you
register. Optionally, provide an NCT number in addition.

Register Trial Page – Trial Identifiers Section
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 Ye
s. 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. Fields are described in the
following table. Items with an asterisk are required fields.
Instructions for recording Trial Identifiers
Field Label

Description/Instructions

Lead Organization Trial Identifier*

Type the ID 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

NCT Number

Type the NCT number in the field provided. This
number is assigned to trials that have been
submitted to ClinicalTrials.gov previously.

Other Trial Identifier

Type 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 Actio
n Column , click Delete.

Recording Trial Identification Information
Recording Trial Identification Information
This section pertains to abbreviated trials only. You must provide a Lead Organization trial identifier for each trial
you register. Optionally, provide an NCT number in addition.

Register Trial Page – Trial Identification Section
How to Complete the Trial Identifiers Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following
table. All fields are required.

Instructions for Recording the Trial Identifiers section
Field Label

Description/Instructions

Lead Organization

Next to Lead Organization, click Look Up Org, and
select the principal administrative organization
responsible for the research protocol from the list of
search results.
Tip
If your trial's lead organization is not
listed, you can register it in the
system at this point. To search for
and register an organization, follow
the instructions in Looking Up
Registered Organizations and Addin
g Organizations to CTRP.

Lead Organization Trial Identifier

Type the unique identification used to identify, name, or
characterize the protocol document, exactly the same
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.
Example: NSABP-B-40

Submitting Organization Name

Next to Submitting Organization Name, click Look
Up Org, and select the name of the organization that
submitted the trial from the list of search results.
Tip
If your trial's lead organization is not
listed, you can register it in the
system at this point.

Submitting Organization Local Identifier

Type the ID exactly the same as it appears in the
protocol document.

NCT Number
Mandatory if an NCT number has been assigned to the
trial.

If the trial has been submitted to ClinicalTrials.gov
previously, enter the number assigned to the trial by
PRS (ClinicalTrials.gov).

Recording Trial Details

Recording Trial Details
This section pertains to complete and abbreviated trials. Not all trial details pertain to them both however, as
indicated in the instructions below.

Add Trial Page – Trial Details Section, Complete Trial

Add Trial Page – Trial Details Section, Abbreviated Trial
How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following
table. All items are required fields.
Instructions for recording Trial Details
Field Label

Trial Category

Description/Instructions

Title

Complete and Abbreviated

Type the trial title up to a maximum
of 4000 characters.
For example: "Study of
Recombinant Vaccinia Virus That
Expresses Prostate Specific
Antigen in Metastatic
Adenocarcinoma of the Prostate"

Trial Type

Complete and Abbreviated

You can not select "Observational"
at this time. 1

Phase

Complete and Abbreviated

Select a phase from the drop-down
list.

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/11 - 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) - For
epidemiologic, cancer
control/behavioral, observational,
ancillary, correlative, or other
biological studies.

Pilot Trial?
(displayed if Phase = NA)

Complete and Abbreviated

If the study is a pilot, as defined
below, select Yes. Otherwise,
select No.

Purpose

Complete and Abbreviated

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

If Primary Purpose is "Other",
describe:
(displayed if Purpose = Other)

Complete and Abbreviated

If the primary purpose is Other,
describe the purpose of the trial.
You do not need to provide a
Purpose Comment for trials with
any other Purpose designation.

Site Principal Investigator

Abbreviated

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

null

Recording Lead Organizations and Principal Investigators
Recording Lead Organizations and Principal Investigators
The Lead Organization is the institution that is the principal administrative organization responsible for the study. In
multi-site trials that do not have a single assigned coordination center, every participating organization can be
named as lead organization.
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.

Add Trial Page – Lead Organization/Principal Investigator Section
How to Complete the Lead Organization/Principal Investigator Section
1. Next to the Lead Organization field, click Look Up, and search for the organization as per the instructions in
Looking up Registered Organizations.
a. If your trial's lead organization is not listed, you can register it in the system at this point. To register an
organization, follow the instructions in Adding Organizations to CTRP.
2. 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 CTRP.

Recording Sponsors and Responsible Parties
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 if you indicated that you do not require an XML document.
The Responsible Party can be either a sponsor or a principal investigator (PI). The term "responsible party" is either
of the following:
Sponsor of the clinical trial (as defined in 21 CFR 50.3 or successor regulation)
- or Principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so
long as the principal investigator is responsible for conducting the trial, has access to and control over the
data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the
requirements for the submission of clinical trial information.
You must complete all fields in the Sponsor/Responsible Party section.

Add Trial Page – Sponsor/Responsible Party Section
If the Responsible Party is the Sponsor, this section expands to display the Responsible Party Personal Contact and
Responsible Party Generic Contact fields.

Add Trial Page – Sponsor/Responsible Party Section, Expanded
How to Complete the Sponsor/Responsible Party Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following
table. Fields marked with an asterisk (*) are required.
Instructions for recording Sponsors/Responsible Parties
Field Label

Description/Instructions

Sponsor*

Click Look Up Sponsor and search for the sponsor as
per the instructions in Looking Up Registered Persons.

Responsible Party*

Indicate the party who is responsible for the trial. Select
one of the following options:
PI (principal investigator). Primary medical
researcher in charge of carrying out a clinical trial's
protocol.
-orSponsor. Name of primary organization that
oversees implementation of study and is responsible
for data analysis. For applicable clinical trials,
sponsor is defined in 21 CFR 50.3. For further
elaboration on the definition of Sponsor with respect
to responsible party, see http://prsinfo.clinicaltrials.go
v/ElaborationsOnDefinitions.pdf.
Selecting the Sponsor option
expands this section and displays
the Responsible Party (a
particular person) and Responsi
ble Party Generic Contact (a
role associated with the
Responsible Party) fields.

Responsible Party Personal Contact

If the sponsor is a particular person rather than a role
(a generic contact), click Look Up Person, and search
for the sponsor as per the instructions in Looking Up
Registered Persons to record the responsible party's
name.

Responsible Party Generic Contact

If the Responsible Contact is a role in the organization,
click Look Up Generic Contact and follow the
instructions in Looking Up Generic Contacts to record
the responsible party's name. The Responsible Party
Email Address and *Responsible Party Phone
Number fields are populated automatically.

Responsible Party Email Address*

Enter the responsible party's contact email address. If
you selected a Generic Contact, these fields are
populated automatically.
Each title or role must be unique.
You can not create one role with
many email addresses and/or
phone numbers.

Responsible Party Phone Number*

Looking Up Generic Contacts

Type the responsible party's phone number. See Enteri
ng Phone and Fax Numbers

Generic contacts are names associated with a role in an organization.
How to Look Up Generic Contacts
1. In the Sponsor field click Look Up Sponsor, and select the appropriate organization.
2. Next to the Responsible Party Generic Contact field, click Look Up Generic Contact.
The Select Responsible Party Generic Contact window appears.

Select Responsible Party Generic Contact Window
3. In the Title field, type the contact's title or part of the title, and then click Search.
The Select Responsible Party Generic Contact window appears.

Select Generic Contact Window
4. In the contact record you searched for, select the contact's email address and phone number from the
drop-down lists, and then click Select.
The title appears in the Generic Contact field, and the contact's email address and phone number appear in
their respective fields below the title.
Correct role or title errors
If the contact role or title you searched for contains an incorrect email address and/or
phone number, do not select an address/number from the drop down list before you click .
Instead, type the correct email address/phone number on the Register Trial page, then
email the CTRO to request a change to the contact role record.

Adding Generic Contacts
If the generic contact is not listed in your search results, you can add the generic contact information.
How to Add Generic Contacts
1.

1. In the Sponsor field click Look Up Sponsor, and select the appropriate organization.
2. Next to the Responsible Party Generic Contact field, click Look Up Generic Contact.
The Select Responsible Party Generic Contact window appears.

Select Responsible Party Generic Contact Window
3. Click Add Generic Contact.
The Add Generic Contact window appears.

Add Generic Contact Window
4. Type the contact's title or role, and contact information in the fields provided, and then click Save.
The record you created appears in the results table at the bottom of the window.

Add Generic Contact Window – Contact Record
5. In the contact record you created, select the contact's email address and phone number from the drop-down
lists, and then click Select.
The title appears in the field, and the contact's email address and phone number appear in their respective
fields below the title.
Correct role or title errors
If the contact role or title you searched for contains an incorrect email address and/or
phone number, do not select an address/number from the drop down list before you click.
Instead, type the correct email address/phone number on the Register Trial page, then
email the CTRO to request a change to the contact role record.

Recording Summary 4 Information
Recording Summary 4 Information
To register complete trials only, the lead organization or at least one participating site must be an NCI-designated
cancer center. Complete all fields in the Summary 4 Information section. The Trial Submission Category or
Summary 4 Funding Sponsor Type fields are pre-populated with the sponsor type (for complete trials) or trial
submission category (for abbreviated trials) you chose at the beginning of the Register Trial process. See I - Clinical
Trial Summary 4 Categories.

Add Trial Page – Summary 4 Information Section for Complete Trials

Add Trial Page – Summary 4 Information Section for Abbreviated Trials
How to Complete the Summary 4 Information Section
1. Click Look up Sponsor, and select the name of the external sponsor or funding source as defined by the
Summary 4 report. See the instructions in Looking Up Registered Organizations.
a. If your trial's funding sponsor is not listed, you can register it in the system at this point. To register an
organization, follow the instructions in Adding Organizations to CTRP.
2. In the Program Code field (for complete trials) or the Site Specific Program Code field (for abbreviated
trials), type the code that includes the study.

Recording NIH Grant Information

Recording NIH Grant Information

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.
An NIH grant identification number consists of several parts, each having a distinct meaning.
For example: 1R01CA009999-08A1S2
where,
1 is the single-digit code identifying the type of application received and processed
R01 (position 2 - 4) is the three-digit code identifying a specific category of extramural activity. It corresponds
to Funding Mechanism element in the NIH grant information section.
CA (position 5 - 6)is the two-letter code identifying the assignment or funding NIH Institute or Center. It
corresponds to Institute Code element in the NIH grant information section.
009999 (position 7 - the dash) is the five- or six-digit number generally assigned sequentially to a series
within an Institute, Center, or Division. It corresponds to the Serial Number element in the NIH grant
information section.
- (dash) separates the serial number from the grant year
08 is the two-digit number indicating the actual segment or budget period of a project The grant year is
preceded by a dash to separate it from the serial number.
A1 is the letter code for a resubmitted application, (commonly referred to as an Amendment) and related
number that identifies a particular amendment record
S2 is the letter code for Revision (for Supplemental funding) and related number identifying a particular
supplemental record.

The Grant Identification Number is also commonly referred to as assignment number, as grant
identification Assignment Number, application number, as grant identification Application
Number, or the award identification number, as grant identification Award Identification Number,
depending upon its processing status.

For a complete guide to NIH grant information, see the following web pages:
http://ocga.ucsd.edu/Proposals/NIH/Grants/Proposal_Preparation.htm
http://grants.nih.gov/grants/funding/funding_program.htm

Add Trial Page – NIH Grant Information Section
How to Complete the NIH Grant Information Section
1. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the
following table. All items are required fields if your study is funded by NIH.
Instructions for recording NIH Grant Information
Field Label

Description/Instructions

Funding Mechanism

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

For a list of NIH grant 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 inter-agency
agreement. The support may be financial or
administrative.
For a list of valid codes, see Institute Codes.

Serial Number

Type the five- or six-digit number generally
assigned sequentially to a series within an Institute,
Center, or Division, for example, 009999.

NCI Division/Program Code

Type the initial letter(s) of the division or program
code, and then select the code for the
organizational unit that provides funding for the
study, from the drop-down list.
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.

Recording Trial Statuses and Dates
Recording Trial Statuses and Dates
This section pertains to complete trials. 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.
It includes the following topics:
Recording Trial Statuses and Dates
Trial Status Transitions
Status Rules for Start and Primary Completion Dates
How to Complete the Status/Dates Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following
table. Items with an asterisk are required fields.
Field Label

Description/Instructions

Current 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 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.

Current Trial Status Date*

Enter the date on which the current trial status became
effective. See Selecting and Entering Dates and Rules
for Status/Dates relationships.

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.

Trial Start Date*

Enter the date on which the trial started, or is expected
to start.
Indicate whether the start date is the one on which the
trial is expected to start, or the date on which it actually
started by selecting Anticipated or Actual. See Rules
for Status/Dates Relationships.

Primary Completion Date*

Select the date on which the trial ended, or is expected
to end.
Indicate whether the start date is the one on which the
trial is expected to be primarily completed, or the date
on which it actually was primarily completed, by
selecting Anticipated or Actual. See Rules for
Status/Dates relationships.

Completion Date*

Select the date on which the trial was completed, or is
expected to be complete.
Indicate whether the start date is the one on which the
trial is expected to be completed, or the date on which
it actually was completed, by selecting Anticipated or
Actual. See Rules for Status/Dates relationships

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.

Valid trials used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values as listed in the table below.
ClinicalTrials.gov status definitions are provided in Recording Site Recruitment Statuses and Dates.

Trial Status Transitions
The table and diagram below illustrate the relationships between statuses. Statuses are recorded in the order
indicated by the arrows.
Trial Status Flow Relationships
A trial can proceed from this
status…

Directly to this status

Or to this status

In Review

Approved
Withdrawn

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

Closed to Accrual and Intervention

Closed to Accrual and Intervention

Completed
Administratively Completed

NA

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

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

Relationships Between Trial Statuses

Status Rules for Start and Primary Completion Dates
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 Anticipated (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 at the bottom of the diagram represent the date rules, relative to the statuses, for
trial Start Dates compared with Primary Completion Dates and Completion Dates.

Status Rules for Start and Primary Completion Dates
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 equal to or greater than the Trial Start Date
The Completion Date is always equal to or greater than the Primary Completion Date
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

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated

Current Trial Status is Complete

All date types must be actual

Recording Site Recruitment Statuses and Dates
Recording Site Recruitment Statuses and Dates
This section pertains to abbreviated trials. Trial status refers to the current stage or state of participant/patient
enrollment at the participating site level.
Valid trial statuses are listed in the table below.
Current trial status definitions
Trial Status in the CTRP
Registration Site

Trial Status in ClinicalTrials.gov

Definition

In Review

Not yet recruiting

Trial is currently under IRB review.

Withdrawn

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

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 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.

Add Trial Page – Status/Dates Section, Abbreviated Trial
How to Complete the Status/Dates Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the
following table. Items with an asterisk are required fields.
Instructions for recording Site Recruitment Statuses/Dates
Field Label

Description/Instructions

Site Recruitment Status*

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

Site Recruitment Status Date*

Enter the date on which the current trial status became
effective. See Trial Status Rules for Start and Primary
Completion Dates.

Date Opened for Accrual

If appropriate, enter the date on which the trial was
opened for accrual.

Date Closed for Accrual

If appropriate, enter the date on which the trial was
closed for accrual.

Trial Status Rules for Start and Primary Completion Dates
Trial Status Rules for Start and Primary Completion Dates
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 Anticipated (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 at the bottom of the diagram represent the date rules, relative to the statuses, for
trial Start Dates compared with Primary Completion Dates and Completion Dates.

Status Rules for Start and Primary Completion Dates
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 equal to or greater than the Trial Start Date
The Completion Date is always equal to or greater than the Primary Completion Date

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

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated

Current Trial Status is Complete

All date types must be actual

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

Add Trial Page – IND/IDE Section
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:
For IND trials:
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
For IDE trials:
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

IND/IDE Holder Type*

Select one of the following typesholder types:
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.
See Institute Codes and NCI Division/Program Codes f
or valid values.

Expanded Access?

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

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

Select one of the following access statuses:

Exempt?

Select the Yes check box in the Exempt? column if the
trial is associated with the U.S. FDA and does not
require IRB approval.

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

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.

Recording Regulatory Information
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.

Regulatory Information Section
How to Complete the Regulatory Information Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following

table. Items with an asterisk are required fields. 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.
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.

Section 801 Indicator*

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.
If you indicated that the trial is
applicable under Section 801, you
are required to complete the Delaye
d Posting field.

Delayed Posting Indicator*

Indicate whether the release of trial information on
ClinicalTrials.gov is being delayed until after an
interventional device has been approved or cleared by
selecting Yes or No.
Select No if the trial does not include a device.

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.

Recording Trial-Related Documents
Recording Trial-Related Documents
You must include each of the following types of documents in order to register your trial:
For complete trials
Complete protocol document
Participating sites (if not included in the protocol document). Multi-site trials require a list of
participating sites and contact information.
Informed Consent (complete trials only, if not included in the protocol document)
If the Informed Consent and/or Participating Sites are not included as part of the
protocol document, upload them separately as "Trial-Related Documents."
For abbreviated trials
Abbreviated Trial Template (if you do not provide an NCT number)
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. Please see the information about creating PDFs in C
onverting Documents to PDFs .

Add Trial Page – Trial Related Documents for Complete Trials

Add Trial Page – Trial Related Documents for Abbreviated Trials

The procedure for uploading documents is the same for all document types.

How to Submit Trial Related Documents
1. Next to the document-type field, (e.g., Protocol Document), click the Browse button.
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 these steps above for each type of document.
Adding Multiple "Other" Documents
You can upload more than one (1) "Other" document. After you have uploaded the first of
your "Other" documents, click the Add More link. A new Other document field is
displayed.

Converting Documents to PDFs
Abstractors use the information provided in the documents you upload in the Registration site to validate and
complete trial data. To facilitate data entry, the abstractors may copy and paste information from your documents
into fields provided in the Protocal Abstraction interface.
Trial-related documents uploaded as Microsoft Word (.doc), Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb), and
WordPerfect files, contain text that can be copied and pasted directly. Documents uploaded as PDFs (portable
document format) contain text that can be copied if the content was created from other text-based applications such
as Word or Excel.
Abstractors are not able to copy and paste text from _scanned_ document pages
PDFs of scanned documents can not be edited, copied, or read with OCR (optical character
recognition) applications, and should therefore be avoided.

Converting Text-Based Files to PDFs in Windows OS
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".

Converting Text-Based Files to PDFs in Mac OSX
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 location, rename your PDF file, and then click Save.

Related Topics
Using CTRP Registration Templates and Resources
Using the Complete Trial Participating Sites Template

Editing Trial Details
Editing Trial Details
You can edit trial details after you have reviewed them at any time before you submit the trial to the CTRP. If you
want to edit a 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.
Related Topics
Registering Multiple Trials in a Batch
Amending Trials
Updating Trials

Printing Trial Information
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.

2. Scroll to the bottom of the Review Trial Details page, and then click Print.

Completing and Deleting Saved Drafts
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.
The systems deletes drafts after 30 days
If you do not complete the registration, the system will automatically delete the draft 30 days after
you have saved it.

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 in the Saved Draft Search Results table.

Saved Draft Record
2. Do one of the following in the appropriate columns on the right side of the table:
To delete the record, click Delete. The draft record is deleted from the system permanently.
- or 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 Main Steps for Registering Trials.
Related Topics
Printing Trial Information
Amending Trials
Reviewing and Submitting Trial Amendments

Registering Multiple Trials
Registering Multiple Trials
You can submit multiple trials for registration by recording trial data in batch templates, preformatted Excel
spreadsheets. There are separate templates for complete and abbreviated trials. Additionally, the way in which you
submit the data differs between the two types of trials.
This section includes the following topics:

Registering Multiple Complete Trials in Batch Files
Registering Multiple Abbreviated Trials in Batch Files

Registering Multiple Complete Trials in Batch Files

Registering Multiple Complete Trials in Batch Files
This section includes the following topics:
Registering Multiple Complete Trials in Batch Files
Main Steps for Uploading Your Complete Trial Data
Preparing Trial Data Files
Trial Requirements
Data Specification Requirements
Template Requirements
Preparing Complete Trial Document ZIP Files
Trial-Related Document Requirements
Submitting Trial Registration Batch Files
As an authorized CTRP submitter you can use the CTRP Registration Site's 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
Registration Site's batch upload feature. CTRO staff 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 CTR
O. 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:
Data documents – Documents that contain all the requisite information about the trial.
Trial-related documents – Protocol and IRB documents, among others.
Main Steps for Uploading Your Complete Trial Data
1. Prepare the trial data file. See Preparing Trial 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 application batch upload web page at http
s://trials.nci.nih.gov/registry/admin/batchUpload.action. See Submitting Complete Trial Registration Batch
Files.
Preparing Trial 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 and Resources.

You must provide trial data in the Microsoft Excel format, .xls.

How to Prepare Trial Data Files
1. Download the batch upload template (Excel spreadsheet) containing the mandatory and optional data for the
trial(s) from http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources.
2. Enter the trial data elements as specified in the template.

The .xls file that contains the trial data you want to register via the CTRP Registration
Site’s batch upload feature, and the trial-related documents associated with it, must meet
certain requirements for successful registration. Refer to the specifications below and in Pr
eparing Trial Document ZIP Files.

Trial Requirements

To ensure successful submission, ensure that your trials conform to the following criteria:
How to Prepare Trial Data Files
1. Download the batch upload template (Excel spreadsheet) containing the mandatory and optional data for the
trial(s) from https://ncisvn.nci.nih.gov/svn/coppa/trunk/documents/trial_batch_templates/current_templates/.
The .xls file that contains the trial data you want to register via the CTRP Registration
Site’s batch upload feature, and the trial-related documents associated with it, must meet
certain requirements for successful registration. Refer to the specifications below and in Pr
eparing Trial Document ZIP Files.

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

Complete
Interventional only

Summary 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

Data Specification Requirements

Accepted and beyond

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

Contact
Generic Contact
Multiple

Data Submission Options

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

Person and Organization Information Options

PO-ID for the person or organization
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 nci
ctro@mail.nih.gov.
Or, you can use the search
organization/person feature in the
CTRP Trial Registration
application to ascertain PO-IDs.

Template Requirements
You must adhere to the following requirements:
List trial elements required for registration in the order specified in the Batch Upload Data Element Spec tab
in the batch upload template.
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".
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.
Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.

You can enter dates in the following formats:
MM/dd/yyyy
MM-dd-yyyy
yyyy/MM/dd
yyyy-mm-dd

Study Type

Complete
Interventional only

Summary 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

Data Specification 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
Data Submission Options

Contact
Generic Contact
Multiple
XML file is required for trial submission to
ClinicalTrials.gov
XML file is not required for trial submission to
ClinicalTrials.gov

Person and Organization Information Options

PO-ID for the person or organization
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 the
CTRP Trial Registration
application to ascertain PO-IDs.

Template Requirements

You must adhere to the following requirements:
List trial elements required for registration in the order specified in the Batch Upload Data Element Spec tab
in the batch upload template.
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.
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.
Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.

Preparing Complete 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.
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. 1
The trial document Zip file that you intend to upload MUST NOT include folders or other Zip files.

Trial-Related Document Requirements
Basic criteria for trial-related documents include the following:
File Types

Microsoft Word (.doc)
Adobe PDF 1

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

null
Submitting Trial Registration Batch 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. For details, see Trial-Related
Document Requirements.
How to Upload Trial Registration Batch Files
1. Navigate to the batch upload URL that you received from the CTRO.
The Batch Upload page appears. All fields are required.

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 the trial data.

Use the most current batch upload template
To ensure that you use the version of the batch upload template that is valid for the
version of the CTRP Registration Site you are using, click the here link, which directs you
to the CTRP web site.

4. Next to the Documents Zip field, click Browse and navigate to the .zip file that contains all the trial-related
documents.
5. Click Upload Trials.
The Batch Trial Upload Confirmation window appears.

Batch Trial Upload Confirmation Window
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.

Related Topics
Registering Multiple Abbreviated Trials in Batch Files
Recording Trial-Related Documents
Searching for Persons
Searching for Organizations

Registering Multiple Abbreviated Trials in Batch Files
Registering Multiple Abbreviated Trials in Batch Files
This section includes the following topics:
Registering Multiple Abbreviated Trials in Batch Files
Main Steps for Submitting Your Abbreviated Trial Data
Preparing Abbreviated Trial Data Files
Trial Requirements
Data Specification Requirements
Template Requirements
Submitting Abbreviated Trial Registration Batch Files
As an authorized CTRP submitter, you can use the CTRP Registration Site's abbreviated batch template to register
multiple new trials that were conducted at a given site, and to update them as necessary. The abbreviated batch
template, a predefined Excel spreadsheet, provides the structure for recording your trial data. Once you have
recorded the trial data, email the spreadsheet to the CTRO. CTRO staff use the information you provide in these
documents to register your trials.

Before You Begin
Contact the CTRO at ncictro@mail.nih.gov to request approval for sending batch files to CTRP.
Include your login name, first and last names, and email address stored in your CTRP profile.
Once you have received approval, you do not have to request approval for subsequent batches.

Main Steps for Submitting Your Abbreviated Trial Data
1. Prepare the trial data file. See Preparing Abbreviated Trial Data Files.
2. Email the file to the CTRO at ncictro@mail.nih.gov as an attachment.
Preparing Abbreviated Trial Data Files
The CTRP web site provides a batch template, valid data values, data definitions, examples, and rules for
registering batches of abbreviated trials.
How to Prepare Trial Data Files for Abbreviated Trials
1. Download the abbreviated trial batch template (Excel spreadsheet) containing the mandatory and optional
data for the trial(s) from http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources.
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. Refer to the specifications below.

Trial Requirements

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

Abbreviated Interventional

Trial Submission Category

Industrial

Processing Statuses for Trial Updates

Accepted and beyond

Data Specification Requirements

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

100 maximum

Person and Organization Data

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 ncict
ro@mail.nih.gov.
Or, you can use the
organization/person lookup features
in the CTRP Trial Registration
application to search for PO-IDs.

Primary purpose, Phase, Disease and Intervention
Data

If you provide an NCT number, the primary purpose,
phase, disease and intervention data are optional.

Template Requirements

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, 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.
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.
Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.
If more than one disease or intervention is included, list them on additional lines, one per line.
Submitting Abbreviated Trial Registration Batch Files
The CTRP website provides an abbreviated trial batch template, valid data values, data definitions, examples, and
rules for registering batches of abbreviated trials.
How to Submit Abbreviated Trial Batch Files
1. In Microsoft Excel, list the trial elements required for registration in the order specified in the
Registry_Abbreviated_Trial_Template.xls file. To access the Registry_Abbreviated_Trial_Template
.xls file, see Downloading Trial Registration Templates.
2. Email the file to CTRO at ncictro@mail.nih.gov as an attachment.
CTRO staff process your file and register your trials.
Trial Ownership
Make sure to clearly indicate, using the appropriate fields in the batch file, which user from your
institution you want assigned as trial owner for each of the trials you are submitting.

Duplicate Trial Management
If the CTRO identifies a trial as a duplicate to an existing trial, you can request that they add your
organization information to the existing trial as a participating site instead of creating a duplicate.
You can send a request to the CTRO to add your organization information to the existing trial as
a participating site using the same template, or, you can create a separate request using the Abb
reviated Participating Sites Template.

Related Topics
Registering Multiple Complete Trials in a Batch
Recording Trial-Related Documents

4 - Updating Trials
4 - Updating Trials
This section describes how to update trials that are currently registered and verified in CTRP.
This section contains the following topics:
About Trial Updates
Updating Trials
Reviewing and Submitting Trial Updates
Editing Updated Details
Printing Updated Trial Information
Changing Trial Status Information

About Trial Updates
View Source

About Trial Updates
The CTRP Registration Site 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 Updating Trial Statuses 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.
Tip
You can also update trials in batches. See Registering Multiple Complete Trials in Batch Files.

Updating Trials
å

Updating Trials
As trial owner, you can update a subset of the information included with the original trial submission, including the
following:
Other trial identifier
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 Recor
ding NIH Trial Statuses/Dates, their definitions in the CTRP Registration Site, and equivalents in
ClinicalTrials.gov.
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.
Updating trial statuses from the Search Results table
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.

How to Update Trials
1. On the navigation pane on the left side of the page, click Search 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" Column - Select Action List
3. In the Available Actions column, click Select action > Update.
The Update Trial page displays the data currently registered with CTRP.
4. Make changes to the fields as necessary. Instructions for recording each of the fields are provided in Register
ing New Trials.
5. 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).
6. To review the information you provided, click Review Trial.
The system checks the updated information for errors, and displays the results at the top of the Update Trial
page.
7. If necessary, correct any errors, and click Review Trial. Repeat this cycle until your update is error-free.
8. Submit the trial update.
The system sends you an update notification — with the details of what has changed — whenever you
update accepted trials.

Reviewing and Submitting Trial Updates
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.

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.

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.

Changing Trial Status Information
Changing Trial Status Information
You can update the trial status and trial status start/completion dates for trials you own without having to update
other trial details.
Processing Requirements
You can change the accrual status of trials that have reached the processing status Accepted or
beyond. Refer to Recording Site Recruitment Statuses and Dates for status definitions.

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.

"Available Actions" Column - Select Action List
2. In the Select action drop-down list, click the Change Status link.
The Update Status window appears.

2.

Update Status Window
3. Make changes to the status information as necessary. If you changed the status to Administratively
Complete, Withdrawn, or Temporarily Closed, enter the reason for status change.
4. Click Save. See Recording Trial Statuses and Dates for detailed instructions.
Related Topics
Rules for Trial Status Start and Primary Completion Dates
Recording Trial Statuses and Dates

5 - Amending Trials
5 - Amending Trials
This section describes how to amend trials currently registered and verified in CTRP.
This section includes the following topics:
About Trial Amendments
Amendment Process Life Cycle
Amending Trials
Reviewing and Submitting Trial Amendments
Editing Amended Details
Printing Amended Trial Information

About Trial Amendments
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 status.
(See the trial processing diagram.) 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.
A trial may have more than one owner. Review the recorded information carefully to see if
another owner has modified the trial.

Most of the information, including documentation, that is required for original submissions is also required in
amendments. To ensure that these requirements are met, you can review, edit, and print your amended data using
the CTRP Registration Site features prior to submission.
You can also amend trials in batches. See Preparing the Trial Data File for Complete Trials.

Related Topics
Amendment Process Life Cycle
Amending Trials
Reviewing and Submitting Trial Amendments

Amendment Process Life Cycle
Amendment Process Life Cycle
The CTRP processes submissions in much the same way as it processes original trial data. You may need to submit
an amendment more than once during the course of your study, and the process is repeated each time you submit
an amendment.
The progression of your trial throughout the phases of the life cycle relies on a series of communications—in the
form of email messages—between you and the system at certain milestone events as follows:
1. The system sends you a submission confirmation letter.
2. The CTRO validates the new data and documents you provided, and the system sends you an acceptance
(or rejection) message. If rejected, the system provides the reason for rejection and reinstates your latest
verified trial.
3. If your amendment is accepted, the CTRO abstracts all the trial details and sends you a Trial Summary
Report (TSR) and XML document that include all the newly-modified data in the CTRP.
4. You review and validate the new TSR and email your approval to the CTRO.
5. If you request a change, the CTRO makes corresponding modifications and re-sends the TSR and XML
documents.
6. 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.

Related Topics
Amending Trials
Reviewing and Submitting Trial Amendments

Amending Trials
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 1
Change Memo 1 – Contains a summary of changes to the original, or last amended, trial submission
Protocol Highlighted Document
IRB Approval for the amended protocol
null
How to Amend Trials
1. On the navigation pane on the left side of the page, click Search 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" Column - Select Action List
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

4.
provided in Registering New Trials.
You are required to provide information for all fields marked with an asterisk (*).
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.
Related Topics
About Trial Amendments
Updating Trials

Reviewing and Submitting Trial Amendments
Reviewing and Submitting Trial Amendments
After you have finished amending the trial information, review the information for errors and edit any details that do
not match the changes in your change memo, amended protocol document, or other source. You can print a copy of
the Amendment Trial and 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 Details.
4. Click Submit.
Related Topics
Amending Trials
Editing Amended Details
Printing Amended Trial Information

Editing Amended Details
Editing Amended Details
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.

Related Topics
Amending Trials
Printing Amended Trial Information

Printing Amended Trial Information
Printing Amended Trial Information
You can print a copy of the amended trial to facilitate the review and/or keep for your records. You must review the
amendment in order to access the print feature. For instructions on reviewing the trial, see Reviewing and
Submitting 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.
Related Topics
Amending Trials
Editing Amended Details

6 - Adding Your Site to Abbreviated Trials
6 - Adding Your Site to Abbreviated Trials
This section provides instructions for adding your site as a participating site to abbreviated trials. You can add your
organization as a participating site to any Industrial 1 (abbreviated) trial, excluding RSS trials, that has the
processing status Accepted or beyond. Once added, you can update your site's record at any time. See Updating
Participating Site Organization Records .
Information that you can update includes the following:
Organization's local trial identifier
Site principal investigator
Site-specific program code
Site recruitment status and dates
null
This section includes the following topics:

Main Steps for Adding Your Organization as a Participating Site
Updating Participating Site Organization Records

Main Steps for Adding Your Organization as a Participating Site
How to Add Your Organization as a Participating Site
1. Search for the trial that your site is participating in by following the instructions in Searching for Trials.
The Available Actions column in the search results table displays actions currently available for the trial.

Available Actions - Add My Site
2. In the search results table's Available Actions column, click Select action > Change Status.
The Add Your Participating Site dialog box appears. The organization associated with your Registration
account appears in the Organization Name field by default.

Add Your Participating Site
3. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the
following table. Items with an asterisk are required fields.
Field

Description/Instructions

Organization Name*

Name of organization added as a participating site.
The organization associated with your Registration
account appears in the Organization Name field by
default.

Local Trial Identifier*

Enter the identifier used at the participating site.

Site Principal Investigator*

Look up the site principal investigator by following
the instructions in Looking Up Registered Persons.

Site Specific Program Code

Optionally, enter the program code used at the
participating site.

Site Recruitment Status*

Select the current stage or state of the trial or study.
Refer to Recording Site Recruitment Statuses and
Dates.

Site Recruitment Status Date*

Enter the date on which the current trial status
became effective. See Trial Status Rules for Start
and Primary Completion Dates.

Date Opened for Accrual

If appropriate, enter the date on which the trial was
opened for accrual.

Date Closed for Accrual

If appropriate, enter the date on which the trial was
closed for accrual.

4. Click Save. Your information is added to the trial details.

Participating Site Added to a Trial Record

Updating Participating Site Organization Records
Appointed participating site record owner(s) and the trial's owner(s) can update information about their respective
organizations in the same trial record. For information about appointed participating site records, see 7 - Managing
Participating Site Record 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 search results table's Actions column, select Update My Site

2.
The Update Your Participating Site dialog box appears. The organization associated with your Registration
account appears in the Organization Name field by default.

Update Your Participating Site
3. Enter the new information in the fields as appropriate, following the instructions in Adding Organizations as
Participating Sites.
4. Click Save. Your information is updated.

Related Topics
Using CTRP Registration Templates and Resources
Searching for Persons
Adding Persons to CTRP

7 - Managing Participating Site Record Ownership
7 - Managing Participating Site Record Ownership
Site Record ownership applies to Industrial (abbreviated) trials only.

This section provides instructions for assigning and un-assigning participating site record ownership to other
registered CTRP users from your organization for abbreviated trials in which your organization is a participant. This
assignment is for your site only on any given trial.
Participating site record 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.
Information that you can update includes the following:
Organization's local trial identifier
Site principal investigator
Site-specific program code
Site recruitment status and dates

As a Site Administrator, you can assign/unassign participating site record 1 ownership to other registered CTRP

As a Site Administrator, you can assign/unassign participating site record 1 ownership to other registered CTRP
users who are affiliated with your organization. You can assign ownership rights to multiple users and multiple trials
at the same time. For example, you can grant ownership to three users within your organization in a single step. Or,
you can grant one user ownership participating sites on three trial records in a single step.
null

Users must have a CTRP Registration Site account, complete with organizational affiliation, in
order for you to grant them participating site trial record ownership.

How to Manage Participating Site Record Ownership
1. On the navigation pane on the left side of the page, click Manage Site Record Ownership.
The Manage Participating Site Record Ownership page displays the names of registered CTRP users on the
left side, and the trials in which your site is a participant on the right.

2. In the Organization Members table, select one or more of your organization's members.
3. Select the trials to which you want to assign or unassign participating site record ownership.
4. Click Assign Ownership or Unassign Ownership.
Related Topics
Adding Organizations as Participating Sites to Registered Industrial Trials
Managing Trial Ownership
Granting and Revoking Administrative Authority

8 - Managing Site Administration Within Your Organization
8 - Managing Site Administration Within Your Organization
This section introduces you to site administration management and provides instructions for granting and revoking
administrative authority.
Each organization registered in the CTRP system can have more than one site administrator 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. 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. See Creating CTRP Registration Site Accounts. Otherwise, request
administration authority from the current site administrator.
To display the administrator(s) currently assigned to your organization, below the Organization
Affiliation field on the My Account page, click View Admins. This feature is displayed only for
those users whose affiliated organizations currently have registered admins.

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. See Managing Trial Ownership .
A site administrator can do the following:
Assign and remove trial ownership
Grant and revoke administrative rights to other users in the organization
Revoke own administrative rights
Site administrators can view and manage trials only for a site playing the lead
organization role.
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.

This section includes the following topic:
Granting and Revoking Administrative Authority

Granting and Revoking Administrative Authority
Granting and Revoking Administrative Authority
As a site site administrator, you can grant and revoke administrative rights to other users 1 in your organization. Site
administrators are the only CTRP Registration Site users who have access to the Site Administration menus on the
navigation pane. No other user will see these menus.

null

How to Grant and Revoke Site Administrator Rights
1. On the navigation pane on the left side of the page, click Site Administration.
If applicable, the Site Administration page displays the current administrators that you previously have
granted administrator rights to.

Site Administration Page
2. To search for a CTRP Registration Site user you want to promote to site administrator, search for the user by
first name, last name, or email address, and then click Search.
The user's name appears in the Search Results list.
3. To promote the user to site administrator, select the check box in the Allow 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.
4. To revoke administrative access, locate the user in the Search Results section, and clear the check box
under the Allow Site Admin column.
5. Click Save.

Related Topics
Managing Site Administration Within Your Organization
Displaying Trial Ownership
Managing Trial Ownership

9 - Displaying Trial Ownership
9 - Displaying Trial Ownership
As a site administrator, you can display trial ownership for any trial owned by your site for which your organization is
the lead organization. Trial ownership allows a user to view trial details, update trials, and amend 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
TSR and XML documents are sent to all trial owners.

How to Display Trial Ownerhip
1. On the navigation pane on the left side of the page, click Display Trial Ownership.
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 Trial Identifier in the field provided, and then click Search.
All owners of the selected trial are listed in the Search Results list.
4. To indicate whether or not an owner of a trial should receive system-generated email messages, in the Recei
ve Email column, select Yes or No.
5. To revoke ownership of a trial, locate the user/trial in the Search Results list, and then click Remove.
Related Topics
Granting and Revoking Administrative Authority
Managing Site Administration Within Your Organization
Managing Organizational Access Through Trial Ownership

8

10 - Managing Trial Ownership
10 - Managing Trial Ownership
This section provides instructions for managing trial ownership.

As a Site Administrator, you can grant and remove trial ownership rights to multiple users 1 and multiple trials 1 at

As a Site Administrator, you can grant and remove trial ownership rights to multiple users 1 and multiple trials 1 at
the same time. For example, you can grant ownership of one trial to three CTRP Registration Site users within your
organization. Or, you can grant one user ownership of three trials.
Trial ownership of abbreviated trials is limited to the original submitter or another CTRO-appointed person upon
request from the organization.
Additionally, you can indicate which of the owners you assign will receive notifications about the trial(s) via email.
null

Users must have a CTRP Registration Site account, complete with organizational affiliation, in
order for you to grant them trial ownership.

How to Manage Trial Ownership
1. On the navigation pane on the left side of the page, click Manage Trial Ownership.
The Manage Trial Ownership page displays the names of your organization's CTRP Registration Site users
on the left side, and your organization's owned trials on the right.

Manage Trial Ownership Page
2. To assign ownership, select the check box in the Allow as Owner? column for each user you want to assign
to a trial(s).
3. On the right side of the page, select the check box in the Select? column for each trial to which you want to
assign ownership.
4. To enable the user to receive email notifications about the trial, select the check box in the Email
Notifications? column.
5. Click Assign Ownership.

5.

Granting Ownership to All Trials
To assign a user(s) ownership to all listed trials, click Check All, and then click Assign
Ownership. You can use the same process to unassign ownership to all trials.

6. To revoke ownership, clear the check box in the Allow as Owner? column for each user you want to
unassign as an owner.
Do not revoke trial ownership from the original trial submitter.
7. On the right side of the page, select the trial(s) to which you want to unassign ownership, and then click Unas
sign Ownership.

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 Trial Status Definitions.) 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.

Related Topics
Granting and Revoking Administrative Authority
Displaying Trial Ownership
Managing Site Administration Within Your Organization

11 - Managing Access to Subject Accruals

11 - Managing Access to Subject Accruals
This section provides instructions for assigning and un-assigning access to the Subject Accruals application on a
trial-by-trial basis, and for reviewing current assignments and trial details.
This section includes the following topics:
Assigning and Un-Assigning Subject Accrual Access
Viewing Accrual Assignment History
Viewing Accrual Assignment History by Trial
You can assign accrual access only to trials that have been abstracted and verified.

Assigning and Un-Assigning Subject Accrual Access
Assigning and Un-Assigning Subject Accrual Access
You can authorize a user to submit subject accrual data for trials that have been fully abstracted and verified.
The table below outlines the access and trial assignment rules for Non-Industrial (Institutional and Externally
Peer-Reviewed) and Industrial trials.
Access/Assignment

Non-Industrial Trial

Industrial Trial

Access Grantor (Who can grant
access?)

A registered user logged in as the
Lead Organization's site
administrator

A registered user logged in as the
site administrator

Grantee (Who can be granted
access?)

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

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

Accessible Trial Types (What trials
can be assigned?)

Non-industrial trials for which the
grantor's organization is the lead
organization

Industrial trials for which the
grantor's organization is the lead
organization or participating site

Access Assignment (How is access
assigned?)

On a per-trial basis; not at the
participating site level

On a per-trial basis; not at the
participating site level

Accrual Submission (Who can
submit accrual data)

Any assigned user, for any
participating site trials for which the
grantor's organization is the lead
organization

Any assigned user affiliated with the
participating site

Assigning Users Accrual Submission Access
How to Assign Subject Accrual Access
1. On the navigation pane, click Assign & Un-Assign Access.
The Manage Accrual Access page appears.

2. Select the category of trial you want to assign, either Industrial, Non-Industrial, or All.
3. Select the user to whom you want to grant access.
The list of trials available for accrual submission for the user you selected is displayed on 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 you want the user to submit accrual data, and then
click the single arrow ( > ) under Assign.
A comment box appears.
You can select multiple trials
To select multiple trials, click one trial, then press and hold the CTRL key and click one or
more others. Then click the single arrow ( > ) under Assign.
To assign all trials, click the double arrow ( >> ) under Assign.

5. In the Comment box, enter a comment about this assignment, and then click Save.
The trials you selected are moved to the Assigned list. The user will have access to them when logged in to
the Subject Accruals application.

Un-Assigning Users Accrual Submission Access
How to Assign Subject Accrual Access
1. On the navigation pane, click Assign & Un-Assign Access.
The Manage Accrual Access page appears.

2. Select the category of trial you want to assign, either Industrial, Non-Industrial, or All.
3. Select the user to whom you want to grant access.
The list of trials available for accrual submission for the user you selected is displayed on the Not Assigned
list on the left side of the page, and trials to which access had previously been granted appear in the
Assigned list on the right.

4. From the Assigned trial list, select the trial to which you want to un-assign access, and then click the single
arrow ( < ) under Un-assign.
A comment box appears.

4.

You can select multiple trials
To select multiple trials, click one trial, then press and hold the CTRL key and click one or
more others. Then click the single arrow ( < ) under Un-Assign.
To assign all trials, click the double arrow ( << ) under Un-Assign.

5. In the Comment box, enter a comment regarding the un-assignment, and then click Save.
The trials you selected are moved to the Not Assigned list, and the user will no longer have access to them.
Related Topics
Viewing Accrual Assignment History
Viewing Accrual Assignment History by Trial

Viewing Accrual Assignment History
Viewing Accrual Assignment History
As a site administrator, you can view a history of your organization's trials to which users have been granted and
revoked user access.
How to View Accrual Assignment History
1. On the navigation pane, click Assignment History.
The Accrual Assignment History page lists all access assignments and un-assigments.

2. To sort the list, click any of the column headers.
An arrow appears to the right of the column header. Click the arrow to change the sort order.
Related Topics
Assigning and Un-Assigning Subject Accrual Access
Viewing Accrual Assignment History by Trial

Viewing Accrual Assignment History by Trial

Viewing Accrual Assignment History by Trial
As a site administrator, you can view a history of your organization's accrual access assignment on a per-trial basis.
How to View Accrual Assignment History by Trial
1. On the navigation pane, click Assignment by Trial.
The Accrual Access Assignment by Trial page lists all access assignments and un-assigments grouped by
trial type.

2. To sort the lists, click any of the column headers.
An arrow appears to the right of the column header. Click the arrow to change the sort order.
Related Topics
Assigning and Un-Assigning Subject Accrual Access
Viewing Accrual Assignment History

12 - Managing Your Account
12 - Managing Your Account
This section provides instructions for modifying your CTRP Registration Site account.

This section includes the following topics:
Resetting Your NCI Password
Retrieving Your Username
Managing Your User Account Profile

Resetting Your NCI Password

Resetting Your NCI Password

You can reset your NCI password from the NCI Password
Station directly, or from the CTRP Registration application
login page.
How to Reset Your NCI Password
Navigate to the NCI Password Station at http://password.nci.nih.gov, or visit NCICB Application Support at htt
p://ncicb.nci.nih.gov/support. Once you have logged in to the NCI Password Station, use the Change
Password feature to create a new password.
- or On the CTRP 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.
Related Topics
Creating CTRP Registration Site Accounts
Logging In to the CTRP Registration Site
Retrieving Your Username

Retrieving Your Username
Retrieving Your Username

You can retrieve your username from the CTRP Registration
Login page.
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.

Managing Your User Account Profile
Managing Your User Account Profile

You can update your account information after you have
registered for an account and have logged in to the CTRP
Registration Site.
How to Edit Your Account Information
1. On the navigation pane on the left side of the page, click My Account.
The My Account page appears, populated with the information you previously supplied for your account.
2. In the Your Account Profile section, make any changes as necessary.

2.

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.

3. Click Submit to save your changes.

Related Topics
Creating CTRP Registration Site Accounts
Logging in to the CTRP Registration Site

13 - Using CTRP Registration Templates and Resources
13 - Using CTRP Registration Templates and Resources
The CTRP provides templates and other resources on their website that you can use to facilitate trial information
gathering and registration. You can also use the templates to update and amend complete trials, and update
abbreviated trials, that you have registered previously. CTRO staff use the information you provide in these
documents to abstract your trials.
This section provides instructions for submitting participating site information for complete and abbreviated trials;
and disease/condition and intervention information for abbreviated trials.
Additionally, batch upload templates guide you through the process of registering multiple trials at one time using the
CTRP Registration Site's batch upload feature. See Registering Multiple Trials.
Instructions, rules, valid values, and specifications for using each of the templates are provided in
the template files themselves.

This section contains the following topics:
Downloading Trial Registration Templates
Using the Complete Trial Participating Sites Template
Using the Abbreviated Trial Participating Sites Template
Using the Abbreviated Trial Template

Downloading Trial Registration Templates
Downloading Trial Registration Templates
You can download the following templates (MS Excel files) from the CTRP website:

Complete trial templates:
CTRP Registry 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 Registry 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.
Abbreviated trial templates:
CTRP Registry Abbreviated Batch Upload Template. Use this template as a guide to record trial data
required for registering multiple interventional abbreviated trials. See Registering Multiple Abbreviated
Trials in Batch Files.
CTRP Registry Abbreviated Participating Sites Template. Use this template to record interventional
abbreviated trial participating site data.
CTRP Registry Abbreviated Trial Template. Use this template to submit disease and intervention
information for an interventional abbreviated trial that does not have an NCT number (and therefore
has not been published in ClinicalTrials.gov). See Using the Abbreviated Trial Template.
How to Download CTRP Templates
1. On the navigation pane, click Useful Templates and Documentation.
The NCI CTRP website Resources page appears in a new browser window.
2. Click the link for the document you want to download.
3. Save the file to your local hard drive.
If you have difficulty locating or downloading the templates, send a request for the files to
application support at ncictro@mail.nih.gov

Using the Complete Trial Participating Sites Template
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.
This section includes the following topics:
Main Steps for Submitting Your Complete Trial Participating Sites Data
Preparing Complete Trial Participating Sites Data Files
Trial Requirements
Data Specification Requirements
Submitting Complete Trial Participating Sites Files

Main Steps for Submitting Your Complete Trial Participating Sites Data
1. Prepare the trial data file. See Preparing Complete Trial Participating Sites Data Files.
2. Upload the file via the trial-related document feature in the Registration application. See Submitting Complete
Trial Participating Sites Files.

2.

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.

Preparing Complete Trial Participating Sites Data Files
The CTRP web site provides a template that 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) from the CTRP web site at htt
p://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources. 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.

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

Complete
Interventional only

Summary 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

Data Specification Requirements
You must adhere to the following requirements:
List trial elements required for registration in the order specified in the template. Collaborator information is
optional.
Do not change the spelling of data elements, valid values, or the order of the columns in the spreadsheet.
Conform to the valid values guidelines when entering trial data. Valid values for each of the trial elements,
where applicable, are listed in the template.
Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.
Participating site information must include the following data elements:
Organization name and address
At least one study site investigator's name and role in the trial
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/contacts 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 lookup features in the CTRP Trial Registration
application to search for PO-IDs.

Submitting Complete Trial Participating Sites Files
You can submit the data file when you register your trial via the Registration application.
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
CTRP_Registry_Complete_Trial_Participating_Sites_Template.xls file. To access the template, see Downloa
ding Trial Registration Templates.
2. Once you have completed the template, upload it via the Trial Related Documents section on the Register
Trial page in the Registration application. For upload instructions, see Recording Trial-Related Documents.
Related Topics
Recording Trial-Related Documents
Downloading Trial Registration Templates
Using the Abbreviated Trial Participating Sites Template

Using the Abbreviated Trial Participating Sites Template
Using the Abbreviated Trial Participating Sites Template
As an authorized CTRP submitter, you can use the CTRP Registry Abbreviated Trial Participating Sites Template to
submit participating site information for industry-lead trials that do not have NCT numbers (and therefore have not
been published in ClinicalTrials.gov). The template, a predefined Excel spreadsheet, provides the structure for
recording your trial data.
This section includes the following topics:

Main Steps for Submitting Your Abbreviated Trial Participating Sites Data
Preparing Abbreviated Trial Participating Sites Data Files
Trial Requirements
Data Specification Requirements
Submitting Abbreviated Trial Participating Sites Files

Main Steps for Submitting Your Abbreviated Trial Participating Sites Data
1. Prepare the trial data file. See Preparing Abbreviated Trial Participating Sites Data Files.
2. Upload the file via the trial-related document feature in the Registration application or email it the CTRO at
ncictro@mail.nih.gov. See Submitting Abbreviated Trial 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
abbreviated interventional trials only.

Preparing Abbreviated Trial Participating Sites Data Files
The CTRP web site provides a template that includes data element requirements, valid values, and rules for
registering abbreviated trial participating sites information.
How to Prepare Abbreviated Trial Participating Sites Data Files
1. Download the Abbreviated Trial Participating Sites Template (Excel spreadsheet) from the CTRP web site at
http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources. 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.

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

Abbreviated Interventional

Summary 4 Trial Submission Category

Industrial

Processing Statuses for Trial Updates

Accepted and beyond

Data Specification Requirements
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 lookup features in the CTRP Trial Registration
application to search for PO-IDs.

Submitting Abbreviated Trial Participating Sites Files
You can submit the data file when you register your trial via the Registration application. Or, email the file to the
CTRO.
How to Submit Abbreviated Trial Participating Sites Files
1. In Microsoft Excel, list the trial elements required for registration in the order specified in the
CTRP_Registry_Abbreviated_Trial_Participating_Sites_Template.xls file. To access the template, see Downl
oading Trial Registration Templates.
2. Once you have completed the template, do one of the following:
Upload it via the Trial Related Documents section on the Register Trial page in the Registration
application. For upload instructions, see Recording Trial-Related Documents.
- or Email the file to the CTRO as an attachment.
Related Topics
Recording Trial-Related Documents
Downloading Trial Registration Templates
Using the Complete Trial Participating Sites Template

Using the Abbreviated Trial Template
Using the Abbreviated Trial Template

As an authorized CTRP submitter, you can use the CTRP Registration Site's abbreviated trial template to submit
disease and intervention information for industry-lead trials that do not have NCT numbers (and therefore have not
been published in ClinicalTrials.gov). The abbreviated trial template, a predefined Excel spreadsheet, provides the
structure for recording your trial data. Once you have completed the template, upload it via the trial-related
document feature in the Registration application. The CTRO requires this information for trial validation.
This section includes the following topics:
Main Steps for Submitting Your Abbreviated Trial Data
Preparing Abbreviated Trial Template Files
Data Specification Requirements
Template Requirements
Submitting Abbreviated Trial Template Files

Main Steps for Submitting Your Abbreviated Trial Data
1. Prepare the trial template file. See Preparing Abbreviated Trial Template Files.
2. Upload the file via the trial-related document feature in the Registration application.

Preparing Abbreviated Trial Template Files
The CTRP web site provides a template that includes data element requirements, valid values, and examples and
rules for registering abbreviated trial disease and intervention information.
How to Prepare Abbreviated Trial Templates
1. Download the abbreviated trial template (Excel spreadsheet) from http://www.cancer.gov/clinicaltrials/conduct
ing/ncictrp/resources.
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. Ensure that you use this template for single
abbreviated interventional trials only.

Data Specification Requirements
Ensure that the template file conforms to the following criteria:
Number of Trials per File

1

Number of Diseases and Interventions per File

At least one disease/condition and one intervention

Template Requirements
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, 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.
Conform to the valid values guidelines in the template when entering trial data.
Identify each trial uniquely. For example, append a unique trial identifier to the file name.

If more than one disease or intervention is included, list each of them on a separate line.

Submitting Abbreviated Trial Template Files
You can submit the template file when you register your trial via the Registration application.
How to Submit Abbreviated Trial Template Files
1. In Microsoft Excel, list the trial elements required for registration in the order specified in the
CTRP_Registry_Abbreviated_Trial_Template.xls file. To access the file, see Downloading Trial Registration
Templates.
2. Once you have completed the template, upload it via the Trial Related Documents section on the Register
Trial page in the Registration application. For upload instructions, see Recording Trial-Related Documents.
Related Topics
Recording Trial-Related Documents
Downloading Trial Registration Templates
Using the Abbreviated Trial Participating Sites Template

A - Working With Persons and Organizations
A - Working With Persons and Organizations
This appendix provides instructions for looking up persons and organizations registered in the Clinical Trials
Reporting Program (CTRP) system, and for adding new persons and organizations to it.
This appendix includes the following topics:
Looking Up Registered Persons
Adding Persons to CTRP
Looking Up Registered Organizations
Adding Organizations to CTRP

Looking Up Registered Persons
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.

How to Look Up Registered Persons
1. Next to the Principal Investigator field, click Look Up Person. The Search Persons window appears.

Search Persons Window
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.
Using wildcard characters ( % )
You can type a series of characters in any of the search fields 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 (%) between characters of the
string as necessary.
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.
Note
You must enter search criteria in at least one field.
3. Click Search. The Select Persons window displays the results of your search.

Search Persons Window-Results
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.

Adding Persons to CTRP
Adding Persons to CTRP

If you are unable to find the person you searched for, you
can request that a person be added to the system.
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. On the Register Trial page, navigate to the Lead Organization/Principal Investigator section.

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

Search Persons Window
3. Click Add Persons. The Add Person window appears.

Add Person Window
4. Enter the person information in the fields provided. Fields marked with an asterisk are required. 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.
5. 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, 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.

Looking Up Registered Organizations
Looking Up Registered Organizations

The procedure for searching for an organization registered
in the Clinical Trials Reporting Program is the same
throughout the application, whether you are searching for a

lead organization, funding source, or other role. To link an
organization to a role, you select the organization's record
from a list of search results.
The procedure below uses the lead organization role on the Register Trial page as an example.

How to Look Up Registered Organizations
1. Next to the Lead Organization field, click Look Up.
The Select Lead Organization window appears.

Search Organizations Window
2. Provide as much information as you can about the organization you are looking for. Or, enter the
Organization Identifier (PO ID) or Cancer Therapy Evaluation Program (CTEP) Identifier. You must enter
search criteria in at least one field.
Using wildcard characters ( % )
You can type 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.
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 Lead Organization window displays the results of your search.

Search Organizations Window – Search Results
Tip
If the lead organization is not listed, you may have searched too narrowly (that is, you may
have provided too much information about the organization). If the list of results is very
long and contains many organizations that are similar to the one you are searching for,
you can narrow your search by providing more information.
4. If the organization does not appear in the results table, do one of the following to modify your search:
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.
Tip
If you still don’t find your organization in the system, you can add it using the Add
Org feature.
5. To link an organization to the trial, scroll through the results list until you locate the correct organization
record, and then click Select.
The organization’s name you selected appears in the Lead Organization field.

Adding Organizations to CTRP
Adding Organizations to CTRP
If you are unable to find the organization you searched for, you can request that an organization be added to the
system.

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 CTRP.
The procedure below uses the Lead Organization on the Register Trial page as an example. The
same fields may not appear in all Add Organization windows however.

How to Add Organizations to CRTP
1. On the navigation pane, click Register Trial, and then scroll down to the Lead Organization/Principal
Investigator section.

Lead Organization/Principal Investigator Section
2. Next to the Lead Organization field, click Look Up Org.
The Select Lead Organization window appears.

Select Lead Organization Page
3. Click Add Org.
The Add Organization window appears.

Add Organization Window
4. In the Organization Name field, type the full name of your organization.
5. Provide information in the fields provided. Fields marked with an asterisk are required.
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.

B - Common Tasks and Data Element Formats
B - Common Tasks and Data Element Formats
This appendix provides detailed instructions for tasks that are common to many of the procedures for registering
trials in the Clinical Trials Reporting Program (CTRP). It includes a key to the icons used throughout the site, and
valid formats for entering such data as dates and phone numbers.
This appendix includes the following topics:
Navigating Search Results Lists
Requesting Trial Summary Reports and XML Documents
Selecting and Entering Dates
Entering Phone and Fax Numbers

Navigating Search Results Lists
Navigating Search Results Lists

The system lists records satisfying search criteria in Search
Results tables. You can navigate through the search results
in several ways, as detailed in the following table.
Methods for Viewing Search Results and Trial Details

To do this...

Do this...

Additional Notes

Sort your results by column

Click the column heading once to
sort the records in ascending order.
Click the column heading again to
reverse the sort order.

-

Move to the next page of results

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

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

Move to the previous page of
results

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

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

Move to a specific page of results

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

-

Move to the first page of results

Click First above or below the list of
results.

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

Move to the last page of results

Click Last above or below the list of
results.

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

Requesting Trial Summary Reports and XML Documents
Requesting Trial Summary Reports and XML Documents
You can request a copy of a Trial Summary Report (TSR) or the XML document for a trial you own if it meets the
following criteria:
The trial is complete
Requires submission to ClinicalTrials.gov (for XML documents)
Has a processing status Abstraction Verified or subsequent status
How to Request TSR and XML Documents
1. On the navigation pane on the left side of the page, click Search Trials to locate the trial for which you want
to request a TSR or XML document.
The trial you searched for appears in the Submitted Clinical Trials Search Results table. Available actions are
listed (if any) for each record.

Search Results Table Action Column –Send XML/TSR
2. In the Available Actions column, click Select action > Send XML/Send TSR.
The system sends the document you requested to the trial's owner(s) and site administrator(s).

Selecting and Entering Dates
Selecting and Entering Dates

You can enter a date in the field directly, or select a date
from the calendar.
How to Select Dates From a Calendar
1. Click the Calendar icon.
The calendar pop-up window appears.

Calendar Pop-up Window
2. Use the carets (> for month, and >> for year) at the top of the calendar to move forward and backward to the
next/previous month or year.
3. Click the date from the calendar.
4. Click Close.
Selecting a date from the calendar records a date/time stamp.

Entering Phone and Fax Numbers

Entering Phone and Fax Numbers
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.

C - Funding Mechanism Codes
C - Funding Mechanism Codes
This appendix provides the values for funding mechanism codes, the NCI codes used to identify areas of extramural
research activity applied to various funding mechanisms.
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

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

D - Institute Codes
D - Institute Codes
This appendix provides the values for codes used to identify NIH, NCI, and funding mechanisms.

Institute Codes
Code

Organization

AA

National Institute on Alcohol Abuse and Alcoholism
(NAAA)

AE

Office of Assistant Secretary For Planning and
Evaluation

AF

Administration For Children and Families

AG

National Institute on Aging (NIA)

AI

National Institute of Allergy and Infectious Diseases
Extramural Activities (NIAID

AM

National Institute of Arthritis, Diabetes, Digestive &
Kidney Diseases

AO

Niaid Research Support

AR

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

AT

National Center For Complementary and Alternative
Medicine (NCCAM)

BC

Division of Basic Sciences (NCI)

BX

Biomedical Laboratory Research & Development

CA

National Cancer Institute (NCI)

CB

Division of Cancer Biology and Diagnosis (NCI)

CD

Office of The Director, Centers For Disease Control &
Prevention

CE

National Center For Injury Prevention and Control

CH

Coordinating Center For Infectious Diseases

CI

National Center For Infectious Diseases (NCID)

CK

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

CL

Clinical Center (CLC)

CM

Division of Cancer Treatment (NCI)

CN

Division of Cancer Prevention and Control (NCI)

CO

Office of The Director (NCI)

CP

Division of Cancer Epidemiology and Genetics (NCI)

CR

Cooperative Research and Development Agreements,
NCI

CT

Center For Information Technology (CIT)

CU

Cooperative Studies Program

CX

Clinical Science Research & Development

DA

National Institute on Drug Abuse (NIDA)

DC

National Institute on Deafness and Other
Communication Disorders (NICDC)

DD

Centers For Disease Control and Prevention

DE

National Institute of Dental and Craniofacial Research
(NIDCR)

DK

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

DP

National Center For Chronic Disease Prev and Health
Promo

EB

National Institute of Biomedical Imaging and
Bioengineering (NIBIB)

EH

National Center For Environmental Health

EM

Environmental Health Services

EP

Epidemiology Program Office

ES

National Institute of Environmental Health Sciences
(NIEH)

EY

National Eye Institute (NEI)

FD

Food and Drug Administration

GD

Office of Genomics and Disease Prevention

GH

Coordinating Office of Global Health

GM

National Institute of General Medical Sciences (NIAMS)

GW

Genome Association Studies (GAS)

HB

Division of Blood Diseases and Resources (NHLBI)

HC

Ivision of Epidemiology & Clinical Applications (NHLBI)

HD

National Institute of Child Health & Human
Development (NICHD)

HG

National Human Genome Research Institute (NHARI)

HI

Division of Intramural Research (NHLBI)

HK

Office of National Center For Public Health Informatics

HL

National Heart, Lung, and Blood Institute (NHLBI)

HM

National Center For Health Marketing

HO

Office of The Director (NHLBI)

HP

Health Resources and Services Administration/bureau
of Health Professions

HR

Division of Lung Diseases (NHLBI)

HS

Agency For Healthcare Research and Quality

HV

Division of Heart and Vascular Diseases (NHLBI)

HX

Health Services Research & Development

HY

Office of Health and Safety

IP

National Center For Immunization and Respiratory
Diseases

JT

Joint Funding

LM

National Library of Medicine (NLM)

MD

National Center on Minority Health and Health
Disparities (NCMHD)

MH

National Institute of Mental Health (NIMH)

MN

Office of Minority Health

NB

Neuroscience Blueprint (NB)

NH

National Institutes of Health

NR

National Institute of Nursing Research (NINR)

NS

National Institute of Neurological Disorders and Stroke
(NINDS)

NU

Division of Nursing

OA

Office of The Administrator, Samhsa

OC

Office of The National Coordinator For Health
Information Technology, OS, HHS

OD

Office of The Director (NIH)

OF

Office of Research Facilities Development and
Operations (ORFDO)

OH

National Institute For Occupational Safety and Health

OL

Office of Logistics and Acquisition Operations (OLAO)

OR

Office of Research Services (ORS)

PC

Division of Cancer Control and Population Science
(NCI)

PH

Public Health Practice Program Office

PR

Office of Chief Public Health Practice

PS

National Center For HIV, Viral Hepatitis, STDS and TB
Prevention

RD

Office of Research & Development

RX

Rehabilitation Research & Development

SC

Division of Clinical Sciences (NCI)

SF

Superfund Basic Research Program (SBRP)

SH

National Center For Health Statistics

SM

Center For Mental Health Services

SP

Center For Substance Abuse Prevention

SU

Substance Abuse and Mental Health Services
Administration

TI

Center For Substance Abuse Treatment

TP

Coordinating Office For Terrorism Preparedness and
Emergency Response

TS

Agency For Toxic Substances and Disease Registry

WH

Women's Health Initiative (WHI, OD)

RC

Center For Cancer Research (CCR)

RG

Center For Scientific Review (CSR)

RM

Nih Roadmap Initiative, Office of The Director (RMOD)

RR

National Center For Research Resources (NCRR)

TW

Fogarty International Center (FIC)

WT

Worker Education Training Program (WETP)

VA

Veterans Affairs

WC

Office of Workforce and Career Development

E - NCI Division and Program Codes
E - NCI Division and Program Codes
This appendix provides the values for NCI Division codes, the codes used to identify the name of the NCI Division
responsible for a grant.
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

OD

Office of the Director, NCI, NIH

OSB/SPORE

Organ Systems Branch/Specialized Programs of
Research Excellence

RRP

Radiation Research Program

TRP

Translational Research

N/A

Not applicable

F - Trial Processing Statuses
F - Trial Processing Statuses
This appendix provides the definitions of each of the statuses that occur during the course of the trial processing
workflow. It also illustrates the workflow so that you can see the relationships between the trial statuses.
Trial statuses are listed and illustrated below.
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. 1
These trials are displayed in PA but not in trial search
results in the Registration application.

null

Trial Processing Workflow
The following procedure describes how a trial submission is processed and verified.
1. Trial submitter submits the trial; the status is Submitted.
2. Document Specialist validates the submission:
If the submission is not valid, the trial status is Rejected.
If the submission is validated by the Document Specialist, the trial status is Accepted.
If there is insufficient information to validate the submission, or the trial has been delayed, the trial can
be placed On Hold.
3. Document Specialist starts trial abstraction:
Administrative processing is started and completed.
Scientific processing is started and completed.
4. Document Specialist completes the abstraction, and starts the QC.
5. Document Specialist completes QC, and the status changes to Abstracted.
6. Document Specialist sends Trial Summary Report (TSR) to the Principal Investigator, and the status changes
to Verification pending.
7. Submitter Principal Investigator receives the TSR and returns feedback to the Document Specialist.
8. Document Specialist receives the feedback, and the status changes to Abstraction Verified-Response.
If the abstraction is not correct, the Document Specialist performs administrative and scientific
processing again.
If the abstraction is correct, the verification is complete.
The following graphic illustrates the flow of a trial submission.

Trial Processing Life Cycle

G - Trial Phase Value Definitions
G - Trial Phase Value Definitions
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/11 - 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) - For epidemiologic, cancer control/behavioral, observational, ancillary, correlative, or
other biological studies.

H - Trial Summary Reports and XML Files
H - Trial Summary Reports and XML Files
The CTRP system generates two types of trial documents that contain abstracted data as follows:
Trial Summary Report (TSR) – Report that presents all abstracted data in an easy-to-read format. The
report is sent as an attachment in an email to the trial submitter 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
highlights the differences between the original and amended versions.
XML File – File that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. This
document is sent only to trial submitters who indicated that an XML file is required for submission to
ClinicalTrials.gov when they registered the trial.
The following is an example of the first two pages of a TSR:

The following is an example of part of an XML file. It contains all abstracted data in code format that can be
submitted to CT.gov for registration.

I - Clinical Trial Summary 4 Categories
I - Clinical Trial Summary 4 Categories
This appendix provides definitions of CTRP trial categories.
Clinical trials in the CTRP are categorized as follows:
Complete. Trials in this category include the following types of interventional trials:
NationalCooperative Group.
American College of Radiology Imaging Network

American College of Surgeons Oncology Group
Cancer and Leukemia Group B
Children’s Oncology Group
Eastern Cooperative Oncology Group
European Organization for Research and Treatment of Cancer
Gynecologic Oncology Group
National Cancer Institute of Canada, Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Southwest Oncology Group
Externally Peer-Reviewed. Externally Peer-Reviewed. R01s and P01s or other trial mechanisms
funded by NIH or supported by other peer-reviewed funding organizations.
Institutional.In-house trials authored or co-authored by cancer center investigators and undergoing
scientific peer-review solely by the Protocol Review and Monitoring System of the Center. The center
investigator should have primary responsibility for conceptualizing, designing and implementing the
trial and reporting results. It is acceptable for industry and other entities to provide some support (e.g.,
drug, devices, other funding) but the trial should clearly be the intellectual product of the center
investigator.
Abbreviated. Abbreviated. Trials in this category are Industrial trials. The design and implementation of
these studies is controlled by the pharmaceutical company.

CTRP Registration Credits
CTRP Registration Credits
The following technical and domain experts contributed to the development of this document.
This section lists the current members of the CTRP Project Team.

NIH/NCI Project Sponsors
Role

Name

Email

Affiliation

Program Officer

Christo Andonyadis

andonyac@mail.nih.gov

NCI-CBIIT

Program Officer

Jose Galvez

galvezjj@mail.nih.gov

NCI-CBIIT

Technical Project Management
Role

Name

Email

Affiliation

Technical Project
Manager

Hemant Undale

hemant.undale@nih.gov

SAIC-Frederick

Technical Project
Manager

Kathleen McCormick

mccormickka@mail.nih.go
v

SAIC-Frederick

CTRP Program Management
Role

Name

Email

Affiliation

CTRP Program Director

Gene Kraus

gene.kraus@nih.gov

NCI-CCCT

Acting Program Manager

Joe Martucci

joseph.martucci@nih.gov

Essex Management

Team Lead, Clinical Trials
Informatics

Gisele Sarosy, MD

gsarosy@mail.nih.gov

NCI-CCCT

Clinical Trials Reporting
Office (CTRO) Manager

Kimberly Eckley

kimberly.a.eckley@lmco.c
om

Lockheed Martin

Software Development Team
Role

Name

Email Address

Affiliation

Project Manager

Edmond Mulaire

mulairee@mail.nih.gov

SemanticBits

Architect/Developer

Hugh Reinhart

hugh.reinhart@macksonc
onsulting.com

Mackson Consulting

Developer

Denis Krylov

denis.krylov@semanticbit
s.com

SemanticBits

Developer

Monish Dombla

monish.dombla@semanti
cbits.com

SemanticBits

Developer

Reshma Koganti

reshma.koganti@semanti
cbits.com

SemanticBits

Developer

Kalpana Guthikonda

kalpana.guthikonda@mac
ksonconsulting.com

Mackson Consulting

Lead Analyst for PA and
Registry

Charles Yaghmour

charles.yaghmour@nih.go
v

Samvit Solutions

Analyst for PA

Sulekha Avasthi

savasthi@samvit-solution
s.com

Samvit Solutions

Analyst for Registry

Farhan Khan

fkhan@samvit-solutions.c
om

Samvit Solutions

UI Engineer

Ben Traynham

ben.traynhamk@semantic
bits.com

SemanticBits

Technical Writers
Role

Name

Email Address

Affiliation

Senior Technical Writer

Lauren Anthone

anthonel@mail.nih.gov

Independent

Technical Writer

Patrick McConnell

patrick.mcconnell@sema
nticbits.com

SemanticBits

Role

Name

Email Address

Affiliation

QA

Vivek Ramani

vivek.ramani@nih.gov

SAIC-F

QA

Paula Brown

brownph2@mail.nih.gov

ESI

QA Team

</pre><Table class="table"><tr><Td>File Type</td><td>application/pdf</td></tr><tr><Td>File Modified</td><td>2012-11-01</td></tr><tr><Td>File Created</td><td>2012-11-01</td></tr></table></div></div></div><hr>
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