Clinical Trials Reporting Program

About CTRP

Who Registers, What Trials & When

How to Register Trials

Frequently Asked Questions - FAQs

CTRP Program - FAQs

Expectations for Grantees - FAQs

Registration - FAQs

CTRP Orientation, Communications, and Support - FAQs

Data Access - FAQs

Resources

Glossary of CTRP Terms

CTRP Acronyms

Guiding You Through the Clinical Trials Registration Process

This site provides information and resources to assist you in understanding NCI's new Clinical Trials Reporting Program (CTRP) and to prepare you for registering clinical trials. It is recommended that you review this site first to become familiar with the program.

Learn more about NCI's new CTRP initiative

Overview of the 2009 phased approach to CTRP reporting

View a 6-step guide outlining the CTRP registration steps and printable worksheet to help you
prepare for registration

Answers questions relating to the purpose of CTRP and specific registration details

Contains a glossary of CTRP terms and acronyms and view an online demo of the new registration tool

Ready to register your trials?

When you are ready to register your trials, go to the
Clinical Trials Registration Tool

Back to Top About CTRP

NCI's new Clinical Trials Reporting Program (CTRP) fulfills a recommendation made by the NCI Clinical Trials Working Group (CTWG) to the National Cancer Advisory Board.

The purpose of the program is to establish a comprehensive database containing regularly updated information on all NCI-funded interventional clinical trials. Grantees will enter specific information about each clinical trial into the database. NCI will use this information to coordinate research efforts to optimize our nation's investment in cancer research.

NCI initiated a phased launch of CTRP, which started January 2009 with a focus on registering interventional trials only. The registration of observational, ancillary and correlative studies will begin in 2010.

Check back regularly for updates.

Back to Top Who Registers, What Trials & When

New interventional trials are to be registered with CTRP using a phased approach in 2009:

Starting 1/5/2009		Five original CTRP sites register new interventional trials Original CTRP sites include: Dana-Farber/Harvard Cancer Center Mayo Clinic Cancer Center Northwestern University, Robert H. Lurie Cancer Center Saint Jude Children's Research Hospital Wake Forest Comprehensive Cancer Center
Starting 7/1/2009		All NCI-Designated Cancer Centers register new interventional trials
Starting 10/1/2009		Grantees other than NCI-Designated Cancer Centers register new interventional trials

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Back to Top How to Register Trials

The following steps are designed to guide you through the registration of trials with NCI's Clinical Trials Reporting Program.

Printable Worksheets

Quick Start Guide - print 6 registration steps

Step 1 Decide whether your organization's interventional trials need to be reported    Step 2 Gather Required Information    Step 3 Create User Account    Step 4 Search Trials    Step 5 Submit Trials    Step 6 Verify Trial Information

Decide whether your organization's interventional trials need to be reported o   Has the trial already been reported to NCI through its Cancer Therapy Evaluation Program (CTEP) or the Division of Cancer Prevention (DCP)? If yes, you do not have to register the trial with CTRP. NCI will transfer data for this trial to CTRP. o   Is your organization an NCI-Designated Cancer Center that is not a CTRP original site? You are scheduled to begin registering new interventional trials beginning July 1, 2009. o   Are you a grantee who is not at an NCI-Designated Cancer Center? You are scheduled to begin registering new interventional trials on October 1, 2009. Gather Required Information Before you begin to register your trials with CTRP, it will be helpful to gather the following information for each trial: o   Lead Organization Trial Identifier o   Trial Title, Type, Phase, Purpose (prevention, treatment, diagnostic) o   Lead Organization and Principal Investigator o   Sponsor / Responsible Party o   Summary 4 Information (Funding Category and Funding Sponsor) o   Status and Status Date (Study Start and Completion Date) o   NIH Grant Information (Funding Mechanism, Institute Code, Serial Number, NCI Division or Program Code) o   IND/IDE Information (Number, Grantor, Holder Type) You will also need to upload the following trial-related documents in support of each trial's registration: o   Protocol Document o   Informed Consent (if not embedded within the protocol document) o   IRB Approval o   List of participating Sites for Multi-Center Studies (if not already described within the protocol document) Create User Account o   Create An Account. Enter an email account and create a password. You will receive a confirmation email. o   Account Profile. Click on the link listed in your confirmation email to activate your account and to enter your Account Profile information. o   Log In. After entering the Account Profile info you will be asked to log in again. If you forgot your password, then reset it. o   Search Screen. You will be routed to a Search Screen after log-in. Search Trials You may want to check if you or someone at your organization has already submitted the trial(s) that you are registering. Also, for multi-center trials you can check if other centers have already registered the trial. Search My Trials. Use this feature to find trials that have been submitted through your account. Search All Trials. Use this feature to view select data on all registered trials within CTRP from all submitting organizations. Submit Trials o   Enter Trial Information. Complete the data fields for each trial. "Drop down" menus can help you make a selection. Fields marked with an asterisk are required. You will not be able to register the trial without completing these fields. o   Upload Trial Documents. The following trial-related documents are required as part of your trial's registration to CTRP:    o   Protocol document    o   Informed consent (if not embedded within the protocol document)    o   IRB approval    o   List of participating sites for multi-center studies (if not already described within the protocol document) You can attach these files just like you attach a file to an email. You can "browse" the files on your computer and select a file. o   Submit. Review the trial information that you have entered and click "Submit." If you need to make any changes after you have submitted the trial, please contact the CTRP staff by email. Verify Trial Information o   Review. You will receive an email within 48 hours letting you whether the trial has been accepted or rejected to CTRP. CTRP will include reason(s) if the trial is rejected in the email (e.g., a duplicate submission, missing documents). The email will also provide you with a unique identifier assigned by NCI for your trial. o   Abstraction. CTRP will abstract information from the protocol and the other supporting documents. CTRP will contact you via email if there are any questions or need for clarification. o   Confirmation. CTRP will send you an email with a Trial Summary Report for your review. You can email us with corrections or questions about the Trial Summary Report. Verify that the trial has been abstracted correctly and respond within 5 business days to let CTRP know if the abstraction is correct. If we have not heard from you within 5 business days, CTRP will assume the Trial Summary Report is acceptable. You will also receive a file that includes the abstracted data elements in a format that may be used to submit the trial to the National Library of Medicine's ClinicalTrials.gov database.

Step 1: Decide whether your organization's interventional trials need to be reported

o	Has the trial already been reported to NCI through its Cancer Therapy Evaluation Program (CTEP) or the Division of Cancer Prevention (DCP)? If yes, you do not have to register the trial with CTRP. NCI will transfer data for this trial to CTRP.
o	Is your organization an NCI-Designated Cancer Center that is not a CTRP original site? You are scheduled to begin registering new interventional trials beginning July 1, 2009.
o	Are you a grantee who is not at an NCI-Designated Cancer Center? You are scheduled to begin registering new interventional trials on October 1, 2009.

Step 2:Gather Required Information

Before you begin to register your trials with CTRP, it will be helpful to gather the following information for each trial:

o	Lead Organization Trial Identifier
o	Trial Title, Type, Phase, Purpose (prevention, treatment, diagnostic)
o	Lead Organization and Principal Investigator
o	Sponsor / Responsible Party
o	Summary 4 Information (Funding Category and Funding Sponsor)
o	Status and Status Date (Study Start and Completion Date)
o	NIH Grant Information (Funding Mechanism, Institute Code, Serial Number, NCI Division or Program Code)
o	IND/IDE Information (Number, Grantor, Holder Type)

You will also need to upload the following trial-related documents in support of each trial's registration:

o	Protocol Document
o	Informed Consent (if not embedded within the protocol document)
o	IRB Approval
o	List of participating Sites for Multi-Center Studies (if not already described within the protocol document)

Step 3: Create User Account

o	Create An Account. Enter an email account and create a password. You will receive a confirmation email.
o	Account Profile. Click on the link listed in your confirmation email to activate your account and to enter your Account Profile information.
o	Log In. After entering the Account Profile info you will be asked to log in again. If you forgot your password, then reset it.
o	Search Screen. You will be routed to a Search Screen after log-in.

Step 4: Search Trials

You may want to check if you or someone at your organization has already submitted the trial(s) that you are registering. Also, for multi-center trials you can check if other centers have already registered the trial.

Search My Trials. Use this feature to find trials that have been submitted through your account.

Search All Trials. Use this feature to view select data on all registered trials within CTRP from all submitting organizations.

Step 5: Submit Trials

o	Enter Trial Information. Complete the data fields for each trial. "Drop down" menus can help you make a selection. Fields marked with an asterisk are required. You will not be able to register the trial without completing these fields.
o	Upload Trial Documents. The following trial-related documents are required as part of your trial's registration to CTRP:

	o	Protocol document
	o	Informed consent (if not embedded within the protocol document)
	o	IRB approval
	o	List of participating sites for multi-center studies (if not already described within the protocol document) You can attach these files just like you attach a file to an email. You can "browse" the files on your computer and select a file.

o	Submit. Review the trial information that you have entered and click "Submit." If you need to make any changes after you have submitted the trial, please contact the CTRP staff by email.

Step 6: Verify Trial Information

o	Review. You will receive an email within 48 hours letting you whether the trial has been accepted or rejected to CTRP. CTRP will include reason(s) if the trial is rejected in the email (e.g., a duplicate submission, missing documents). The email will also provide you with a unique identifier assigned by NCI for your trial.
o	Abstraction. CTRP will abstract information from the protocol and the other supporting documents. CTRP will contact you via email if there are any questions or need for clarification.
o	Confirmation. CTRP will send you an email with a Trial Summary Report for your review. You can email us with corrections or questions about the Trial Summary Report. Verify that the trial has been abstracted correctly and respond within 5 business days to let CTRP know if the abstraction is correct. If we have not heard from you within 5 business days, CTRP will assume the Trial Summary Report is acceptable. You will also receive a file that includes the abstracted data elements in a format that may be used to submit the trial to the National Library of Medicine's ClinicalTrials.gov database.

If you have questions or comments regarding this document, or other CTRP topics, please contact NCICB Applications Support at:

Email:	ncicb@pop.nci.nih.gov
Web site:	http://ncicb.nci.nih.gov/NCICB/support
Toll-free:	888-478-4423
Phone:	301-451-4384
Live telephone support is available Monday to Friday, 8 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

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Back to Top Frequently Asked Questions - FAQs

CTRP Program >>

• What is the purpose of the Clinical Trials Reporting Program (CTRP)?
• How will CTRP be connected to other databases within NCI and NIH?
• Will CTRP support the Cancer Centers Summary 4 Report?
• Will CTRP register my trials with clinicaltrials.gov for me?
• If I register a trial with CTRP, will CTRP send the trial to PDQ?

• How do I register trials with CTRP?
• What trials does NCI expect to be registered in CTRP?
• What data do I need to report and when?

• Are usernames and passwords required to register trials to CTRP?
• Is batch registration available?
• Will NCI work with us and/or our vendor to develop a link to CTRP?
• How do I know that my trials have been registered successfully?
• When can I view a trial?
• How do I modify trials or handle errors?
• How do I know if a trial has been previously submitted to NCI?
• What formats are acceptable for uploaded supporting trial documents?
• What is the NCI Division/Program Code?
• What should be in the NCI Grant Information section?

• How does NCI intend to notify grantees about CTRP reporting?
• Is there a mailing list to receive CTRP communications?
• What type of training or orientation will be provided?
• How do I get support and find further information?
• Whom can I contact for assistance?

• Will I have access to data from my submissions?
• Will it be shared with grantees or others outside of NCI?

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Back to Top CTRP Program - FAQs

• What is the purpose of the Clinical Trials Reporting Program (CTRP)?
• How will CTRP be connected to other databases within NCI and NIH?
• Will CTRP support the Cancer Centers Summary 4 Report?
• Will CTRP register my trials with clinicaltrials.gov for me?
• If I register a trial with CTRP, will CTRP send the trial to PDQ?

What is the purpose of the Clinical Trials Reporting Program (CTRP)?
In January 2004, the Director of the National Cancer Institute (NCI) established the Clinical Trials Working Group (CTWG) to advise the National Cancer Advisory Board (NCAB) on whether and in what ways the NCI-supported national clinical trials enterprise should be restructured to realize the promise of molecular medicine for advancing oncologic clinical practice in the 21st century. The result of the CTWG's work was a compendium of 22 initiatives detailed in the group's 2005 report "Restructuring the National Cancer Clinical Trials Enterprise" (http://integratedtrials.nci.nih.gov). First and foremost in the report is a series of coordination initiatives. As the report notes:

"The CTWG envisions an enhanced cancer clinical trials enterprise in which increased participation by the extramural community in the prioritization process more effectively focuses resources on those trials judged most likely to facilitate advances in treatment. The success of this strengthened prioritization process depends on a shared foundation of comprehensive, up-to-date information about the status of cancer clinical trials."

The Clinical Trials Reporting Program (CTRP) fulfills a major initiative of the CTWG report: to provide this shared foundation of information by establishing a comprehensive database containing regularly updated information on all NCI funded clinical trials. The database will provide a centralized repository of trials with information collected using standardized data entry fields. NCI will use these data to coordinate efforts to optimize our nation's investment in cancer research.

How will CTRP be connected to other databases within NCI and NIH?
The CTRP informatics system is based on NCI Enterprise Services, a set of common, shared information services. CTRP will receive data from databases maintained within the Cancer Therapy Evaluation Program (CTEP), the Division of Cancer Prevention (DCP) and the Center for Cancer Research (CCR), using NCI Enterprise Services where possible and file transfer where not. It is expected over time that synchronization between all systems will be seamlessly migrated to NCI Enterprise Services.

In addition, CTRP will send data to NCI's Physician Data Query (PDQ) database. It will also generate and deliver files to submitters in formats suitable for upload to clinicaltrials.gov in fulfillment of reporting obligations under the FDA Amendments Act of 2007.

Will CTRP support the Cancer Centers Summary 4 Report?
CTRP is working with the NCI Cancer Centers Branch to address the reporting requirements for Summary 4. It is anticipated that this will be available in 2010.

Will CTRP register my trials with clinicaltrials.gov for me?
No. It is not possible for NCI to continue to offer this service that PDQ has provided for a number of years, either through CTRP, PDQ or any other system. The Office of the General Counsel within the National Institutes of Health (NIH) has determined that the FDA Amendments Act of 2007 (FDAAA) no longer allows NIH, or any agency, to submit data to clinicaltrials.gov on the behalf of grantees. As a result, NCI will have to phase out the service currently made available by PDQ and transform the capability into one compliant with FDAAA.

FDAAA uses the concept of "responsible party" to describe the individual legally responsible for making the submission of a clinical trial report to clinicaltrials.gov. The NIH definition of "responsible party" can be found at http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf. NCI cannot make a submission to clinicaltrials.gov on behalf of the "responsible party". Accordingly, and to make submission as easy as possible, CTRP generates, as part of its abstraction process for registered trials, an extended markup language (XML) file in a format suitable for use by the grantee in posting to clinicaltrials.gov. This file can easily be uploaded to clinicaltrials.gov by the grantee. Grantees will have an opportunity to review the XML file (and supporting CTRP information) and request changes to it.

NCI intends to wait until the phased deployment of CTRP includes all NCI grantees before eliminating the ability to submit from PDQ to clinicaltrials.gov.

If I register a trial with CTRP, will CTRP send the trial to PDQ?
Yes. CTRP is intended to act as a "one stop shop" for reporting. Data entered into CTRP will be sent to PDQ.

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Back to Top Expectations for Grantees - FAQs

• How do I register trials with CTRP?
• What trials does NCI expect to be registered in CTRP?
• What data do I need to report and when?

How do I register trials with CTRP?
Trials may be submitted online via the NCI Clinical Trials Registration Portal, available at http://trials.nci.nih.gov/registration.

Registration requires the entry of approximately 15-20 data elements and upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites.

Alternatively, registration of trials may be achieved with batch upload, using a standard .xls (Microsoft Excel) format. The specification of this format may be found at http://ctrp.nci.nih.gov/CTRP%20Trial%20Registration_batch_upload_spec_v1_1.xls. Technical support is available at NCI Application Support, by phone (301-451-4384 or toll free at 888-478-4423) or by e-mail (ncicb@pop.nci.nih.gov).

What trials does NCI expect to be registered in CTRP?
NCI expects CTRP registration for all NCI-supported interventional clinical trials that were opened to accrual on, or after, January 1, 2009.

In addition to registration of new trials, NCI will expect grantees to register all existing NCI-supported trials that were open to accrual as of January 1, 2009. NCI is asking grantees to begin registering existing trials one quarter after they began entering new trials. For instance, the first five sites that began entering new trials in January 2009 will start entering existing trials in April 2009; Early Adopter sites that began entering new trials in April 2009 will start entering existing trials in July 2009, and so on.

"NCI-supported" means "all trials sponsored or otherwise financially supported by NCI". For instance, NCI expects all interventional clinical trials, however sponsored, conducted in NCI-designated cancer centers to be registered (with the below exception). Put another way, trials that NCI-designated cancer centers would report as interventional trials in the Cancer Center Summary 4 Report to NCI are included in the CTRP expectations. This includes industry-sponsored and investigator-initiated trials at NCI-designated Cancer Centers.

For grantees outside NCI-designated Cancer Centers, NCI expects CTRP registration of NCI-sponsored trials only (again with the below exception). The exception is that trials reviewed and monitored by NCI CTEP, DCP and CCR need not be registered, as this information will be transferred within NCI. This includes all CTEP trials submitted via the Clinical Data Update System (CDUS), including all Cooperative Group trials, and all early phase trials submitted to the Clinical Trials Monitoring System (CTMS) operated by Theradex.

Registration of observational, ancillary and correlative studies will not take place until 2010 at the earliest.

What data do I need to report and when?
CTRP is being launched in phases. A six-month operational pilot involving five NCI-designated Cancer Centers took place in the second half of 2008. Beginning in January 2009, the same five sites began registering new trials in the production CTRP. Starting in April 2009, solicited "Early Adopter" sites will begin registering new trials in CTRP. It is envisaged that all NCI-designated Cancer Centers will begin registering new trials to CTRP in July 2009, with non-NCI-designated Cancer Centers starting to register new trials in October 2009.

You can submit trials using the NCI Clinical Trials Registration Portal (http://trials.nci.nih.gov/registration). Registration requires the entry of approximately 15-20 data elements and the upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites.

CTRP will begin accepting the entry of study amendments in the second calendar quarter of 2009.

CTRP will begin accepting the entry of accrual data in the fourth calendar quarter of 2009.

It is expected that in early 2010 CTRP will begin a pilot project to accept outcome and adverse event data, with a transition to production later in 2010.

Back to Top Registration - FAQs

• Are usernames and passwords required to register trials to CTRP?
• Is batch registration available?
• Will NCI work with us and/or our vendor to develop a link to CTRP?
• How do I know that my trials have been registered successfully?
• When can I view a trial?
• How do I modify trials or handle errors?
• How do I know if a trial has been previously submitted to NCI?
• What formats are acceptable for uploaded supporting trial documents?
• What is the NCI Division/Program Code?
• What should be in the NCI Grant Information section?

Are usernames and passwords required to register trials to CTRP?
The NCI Clinical Trials Registration Portal requires a username and password, however, it is a self-registering process and the user sets up their own account and password.

Is batch registration available?
Yes. The Microsoft Excel specification for batch registration is available at http://ctrp.nci.nih.gov/CTRP%20Trial%20Registration_batch_upload_spec_v1_1.xls. Technical support is available at NCI Application Support, by phone (301-451-4384 or toll free at 888-478-4423) or by e-mail (ncicb@pop.nci.nih.gov).

Will NCI work with us and/or our vendor to develop a link to CTRP?
No "link" is required. The data submission specification for CTRP is a simple Extended Markup Language (XML) file. Technical support is available at NCI Application Support, by phone (301-451-4384 or toll free at 888-478-4423) or by e-mail (ncicb@pop.nci.nih.gov).

An alternative approach is possible, involving system developers and vendors making their applications able to consume of NCI Enterprise Services. The NCI Center for Biomedical Informatics and Information Technology can supply further information via NCI Application Support, by phone (301-451-4384 or toll free at 888-478-4423) or by e-mail (ncicb@pop.nci.nih.gov).

How do I know that my trials have been registered successfully?
Once you have submitted your trial for registration, you will receive an automated e-mail acknowledgment from NCI confirming the submission. The NCI Clinical Trials Reporting Office (CTRO) will then review your submission. After a successful registration, the NCI CTRO will abstract additional data elements from the protocol and create a Trial Summary Report. You will receive an e-mail notice from CTRP along with the Trial Summary Report as an attachment. You will be asked to verify the accuracy of the abstracted information within the Trial Summary Report and respond to the CTRO with your corrections or acceptance. After 5 business days with no response, the Trial Summary Report will be assumed to be acceptable. Once the Trial Summary Report has been accepted, an XML file suitable for posting trial information to ClinicalTrials.gov will be sent to you.

You will receive an e-mail message from CTRP if your registration cannot be accepted, along with the reason(s) for this (e.g., missing information, missing attached documents, etc.).

When can I view a trial?
Once a trial has been reviewed and successfully registered in CTRP, the limited set of registration data elements can be viewed by all CTRP users with a valid account. Trial Summary Reports and the clinicaltrials.gov file can only be reviewed by the submitter for the given trial.

How do I modify trials or handle errors?
Modifications to data entered (but not submitted) may be made by trial submitters at any time during an online session prior to clicking on the "Submit to NCI" button in the NCI Clinical Trials Registration Portal. Once a trial has been submitted to NCI, direct access to the data elements for editing is not possible. Submitted trial modifications may be done through direct communication with the Clinical Trials Reporting Office (CTRO).

The ability to directly submit amendments to trials will be available during the second calendar quarter of 2009.

How do I know if a trial has been previously submitted to NCI?
Before submitting a trial, it is recommended that you search previously submitted trials to avoid duplication. The following steps outline how to search submitted trials:

1. Go to https://trials.nci.nih.gov/registration
2. Click "Search Trials" on the left menu sidebar
3. Login using your registration account. If you do not have a registration account; click "New Account/Reset Password" and follow the online instructions.
4. Once you have successfully logged in, the Search Trials page will appear.
5. Click "Search My Trials" for all trials you have submitted; click "Search All Trials" to view all trials you have submitted, as well as those trials that have been successfully registered in CTRP (registration data elements only).
6. Provide one or more search criteria for the trial you want to retrieve.
7. The search results page will appear with a list of trials that met your criteria.

NOTE: Only the submitter will be able to view their submitted trials prior to their validation by the Clinical Trials Reporting Office (CTRO). Once they have been validated by the CTRO and registered in CTRP, a limited set of registration data elements will be able to be viewed by all CTRP users who have a valid account.

What formats are acceptable for uploaded supporting trial documents?
CTRP accepts Microsoft Word, Adobe PDF and WordPerfect formats.

What is the NCI Division/Program Code?
NCI Division/Program Code refers to acronyms and corresponding names for organizational units within the NCI (Divisions, Program and Offices) that provide funding. If this information is not known, consult your grants/contracts contacts or the NCI Office of Grants Administration. NCI organizational units that provide funding include the following:

• CCR: Center for Cancer Research
• CTEP: Cancer Therapy Evaluation Program
• DCB: Division of Cancer Biology
• DCCPS: Division of Cancer Control and Population Scientists
• DCEG: Division of Cancer Epidemiology and Genetics
• DTP: Developmental Therapeutics Program
• DCP: Division of Cancer Prevention
• DEA: Division of Extramural Activities
• OD: Office of the Director
• OSB/SPOREs: Organ Systems Branch / Specialized Programs of Research Excellence
• CIP: Cancer Imaging Program
• CDP: Cancer Diagnosis Program
• TRP: Translational Research Program
• RRP: Radiation Research Program

What should be in the NCI Grant Information section?
The information requested in the grant section consists of several elements that identify the funding mechanism. Additional information on grants can be found by accessing the website: http://deais.nci.nih.gov/Query/search/

A decomposition of a complete sample grant number follows; however, you only need to enter the Funding Mechanism, Institute Code and Serial Number into the NCI Clinical Trials Registration Portal:

Grant number example: 1Y01CM009999-01A1S2

Type	Funding Mechanism	Institute Code	Serial Number	Year	Suffix
1	Y01	CM	009999	01	A1S1

Type: A single-digit code that appears at position 1 of the example. It identifies the type of application received and processed. Note: this is not required for CTRP.

Funding Mechanism: A three-character code, located at positions 2-4. It is used to identify areas of extramural research activity applied to funding mechanisms.

Institute Code: A two-character code (positions 5-6) which identifies the NIH Institute that directly funded the award. It identifies the first major-level subdivision and the organization that supports a grant, contract, or inter-agency agreement. The support may be financial or administrative.

Serial Number: A 6 digit number (positions 7-12) that is assigned sequentially to a series within an Institute, Center, or Division. Used as an identifier for the grant.

Year: A two-digit number (positions 13-14) that specifies the current year within an award. Indicates the actual segment or budget period of a project. Note: this is not required for CTRP.

Suffix: A numeric or alphanumeric string, beginning in position 15. It is the code that identifies grant supplement, amendment or a fellowship's institutional allowance. Suffix designation follows the grant year. Note: this is not required for CTRP.

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Back to Top CTRP Orientation, Communications, and Support - FAQs

• How does NCI intend to notify grantees about CTRP reporting?
• Is there a mailing list to receive CTRP communications?
• What type of training or orientation will be provided?
• How do I get support and find further information?
• Whom can I contact for assistance?

How does NCI intend to notify grantees about CTRP reporting?
NCI has developed a communications plan to routinely communicate CTRP information to grantees and the NCI community. Methods of communication include e-mail, listservs, conferences, websites and articles in the NCI Cancer Bulletin articles. Visit http://cancer.gov/ncictrp for comprehensive information about CTRP.

Is there a mailing list to receive CTRP communications?
Yes. Please send an email to the CTRP mailbox (ncictrp@mail.nih.gov) and request to be added to the CTRP communications e-mail list.

What type of training or orientation will be provided?
No special certification is required to submit trials to CTRP. An online, self-guided tutorial and a start-up guide for registering clinical trials in CTRP will be available to the NCI cancer community on the http://cancer.gov/ncictrp web site. The NCI Clinical Trials Registration Portal also contains extensive online instructions. If you have questions or comments on CTRP, you may also contact NCICB Applications Support at:

• E-mail: ncicb@pop.nci.nih.gov
• Web: http://ncicb.nci.nih.gov/NCICB/support
• Toll-free: 888-478-4423 Phone: 301-451-4384
• Live telephone support is available Monday to Friday, 8 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

How do I get support and find further information?
Additional support is available on the CTRP informational website at http://cancer.gov/ncictrp.

Whom can I contact for assistance?
NCICB Applications Support offers live telephone support, Monday to Friday, 8 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

• Email: ncicb@pop.nci.nih.gov
• Toll-free: 888-478-4423
• Phone: 301-451-4384
• Web: http://ncicb.nci.nih.gov/NCICB/support

Back to Top Data Access - FAQs

• Will I have access to data from my submissions?
• Will it be shared with grantees or others outside of NCI?

Will I have access to data from my submissions?
Yes. In response to requests from users, NCI is developing reporting systems to allow submitting organizations to use CTRP for their own clinical research portfolio management.

Will it be shared with grantees or others outside of NCI?
Protocol documents, IRB approval, Informed Consent forms, and Trial Summary Reports will not be shared with anyone other than the submitter.

Once a trial has been successfully registered with CTRP, the initial set of data elements supplied by the submitter when registering the trial, can be viewed by all CTRP users who have a valid user account.

Trial data elements abstracted by NCI's CTRO that correspond to clinicaltrials.gov data elements may be shared to the same extent they are on clinicaltrials.gov.

Back to Top Resources

Here are helpful tools to guide you through CTRP registration:

• Glossary of CTRP Terms and Acronyms
• Online Demo of the CTRP Registration Application

If you have questions or comments regarding this document, or other CTRP topics, please contact NCICB Applications Support at:

• Email: ncicb@pop.nci.nih.gov
• Web site: http://ncicb.nci.nih.gov/NCICB/support
• Toll-free: 888-478-4423; phone 301-451-4384
• Live telephone support is available Monday to Friday, 8 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

Back to Top Glossary of CTRP Terms

Terms [ A - D ] [ E - J ] [ K - O ] [ P - Z ] and Acronyms

A - D Terms

Abstraction (trial) - Identification and extraction (“abstraction”) of information from the submitted protocol document by the NCI Clinical Trials Reporting Office (CTRO) staff to complete data element fields in the CTRP database.

Accrual submission (trial) - Collection of de-identified participant level data, with a focus on demographical information, that are associated with a particular trial/study by organizations providing information to the NCI Clinical Trials Reporting Office (CTRO).

Activation - In the CTRP, this term usually refers to the official start date of a trial as is determined as follows 1) the date of activation noted in an official clinical trial activation announcement or 2) date of first patient accrual if the trial in question did not have a formal activation announcement.

Arm label - the short name used to identify the arm (Source: http://prsinfo.clinicaltrials.gov/)

Arm description - a brief description of the arm (Source: http://prsinfo.clinicaltrials.gov/)

Arm type -

• Experimental: An arm or group in which an experimental drug or regimen is being administered. This will be used when the trial specifies that one arm is a control arm and the other is experimental, or when the other arm is a placebo arm. In cases where patients are not randomized but assigned to groups according to certain characteristics (e.g., risk characteristics, age, diagnosis), use "experimental" for all groups/strata because they are not being compared.
• Active comparator: An arm or group in which active drugs are given. This will include arms that are mixing active drugs and placebos. This will be used when the term "control arm" is specified in the protocol and when another arm is designated as the experimental arm. There can be more than one active comparator arm.
• Placebo comparator: An arm or group in which ONLY a placebo is given.
• Sham comparator: An arm or group in which ONLY a mock therapy that is not a drug is administered.
• No intervention: An observational arm or group.
• Other: An arm or group which does not fall into any of the above

Clinical Trials Reporting Program (CTRP) - the operational implementation of an initiative proposed by the Clinical Trial Working Group (CTWG), which is compromised of NCI policies and standard operating procedures, the staff in the Clinical Trials Reporting Office (CTRO) and supporting technologies (database & portals for registration, abstraction, accrual & report generation).

Clinical Trials Reporting Office (CTRO) - the functional unit within the NCI that performs the operational work of the Clinical Trials Reporting Program (CTRP)

Diagnostic - Characteristic or indicative of (e.g., a disease). (NCI Thesaurus)

Diagnostic procedure - Methods, procedures, and tests performed to diagnose disease, disordered function, or disability. (NCI Thesaurus)

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E - J Terms

Expanded Access - a study type that addresses the process for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment on a clinical trial or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. (Source: http://prsinfo.clinicaltrials.gov/)

Extensible Markup Language (XML) - A general-purpose markup language for creating special-purpose markup languages. It is capable of describing many different kinds of data. Its primary purpose is to facilitate the sharing of data across different systems, particularly systems connected via the Internet. [Source: NCI] C45967

Grant number (NIH and/or NCI grants) - A grant number is a concatenation of a number of elements that identifies grants specifically funded by NCI or NUH, which provide the monies for the trials or infrastructure associated with the research.

Health Services Research - Protocol designed to evaluate the delivery, processes, management, organization or financing of health care. (Source: http://prsinfo.clinicaltrials.gov/) The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome.

Investigational New Drug (IND) - A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.(NCI Thesaurus C49135).

Interventional Trial - Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic, behavioral or other types of interventions. The assignment of the intervention may or may not be random. The individuals are followed and biomedical and/or health outcomes assessed. (Source: http://prsinfo.clinicaltrials.gov/) A pre-clinical or clinical study in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. The individuals are then followed and biomedical and/or health outcomes are assessed. (NCI Thesaurus C16140).

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K - O Terms

Lead organization - The principal administrative organization responsible for the research conducted. [Source: NCI] C63409.

Lead Organization Trial Identifier - One or more characters assigned by the organization providing oversight for the study which is used to identify, name, or characterize the protocol document.

New - A trial that has just received initial approval from the IRB and has not been reported previously

Observational trials/studies - Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants. [Source: NCI] C16084are defined as studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Other (relative to lists) - NCI Different than the one(s) previously specified or mentioned. (NCI Thesaurus C17649). Includes any other term not included in a list.

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P - Z Terms

Phase (trial) - One in a set of successive stages in a progression or sequence such as:

1. A step in the progression of a therapy from initial experimental use in humans to post market evaluation.
2. A stage in the conduct of a clinical trial NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
3. A distinguishable part, a stage in a series of events or in a process of development, e.g. any of the varying aspects or stages in course of a disease.

Phase 0 (trial) - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) (Source: http://prsinfo.clinicaltrials.gov/). A clinical trial that uses a treatment or investigational agent that is available only in very limited quantities and which has never previously been given to humans or for which there is extremely limited human experience. Phase 0 clinical trials are intended to enable researchers to understand the path of the drug in the body and its efficacy. Adverse event reporting in Phase 0 trials is expedited.

Phase I (trial) - Includes initial studies to determine the metabolism and pharmacologic action of drugs in humans and the side effects associated with increasing dose may include healthy participants and/or patients. (Source: http://prsinfo.clinicaltrials.gov/).

Phase I/II (trial) - for trials that are a combination of Phases 1 and 2. (Source: http://prsinfo.clinicaltrials.gov/).

A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. CDISC

Phase II (trial) - Controlled clinical studies conducted to evaluate the effectiveness of the drug 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 associated with the drug. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention. (NCI Thesaurus C15601).

Phase II/III (trial) - A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.

A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.

Phase III (trial) - A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo. (NCI Thesaurus C15602)

Phase IV (trial) - Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

Phase-N/A (trial) - For trials without phases. (Source: http://prsinfo.clinicaltrials.gov/). The designation of a phase may not be applicable to all studies, such as observational.

Primary Purpose: Reason for the protocol (Source: http://prsinfo.clinicaltrials.gov/). The objective of the trial, especially with regard to the type of trial and its targeted outcomes. For clinicaltrials.gov the valid value list includes the following:

For summary IV, (please include a brief statement about what summary 4 is. Not everyone reading this glossary will be familiar with it. the valid values list includes the following:

• CDISC definition for INVESTIGATOR - an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

PROGRAM PI for the person who is the head of a coop agreement or grant under which an investigation or series of investigations are being conducted.

Registration ( as it pertains to CTRP trial) - Initial clinical trial profile data that a grantee and/or site provides to NCI's Clinical Trials Reporting Office (CTRO) as part of Clinical Trials Reporting Program (CTRP).

Responsible Party - The sponsor of the clinical trial (as defined in 21 CFR 50.3) or the 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.(Source: 21 CFR 50.3).

Screening - [CT.GOV] 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). A process of active consideration of potential subjects for enrollment in a trial. [Source: NCI] C48262 Clinical studies testing the efficacy of devices, techniques, procedures, or tests for the purpose of detecting the presence of disease, usually before there are any symptoms.

Study type - nature of the investigation that includes interventional, observational and expanded access studies (Source: http://prsinfo.clinicaltrials.gov/).

Submitting organization - Grantee and/or site who is supplying data to NCI's Clinical Trials Reporting Office (CTRO) as part of the Clinical Trials Reporting Program (CTRP).

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. (Source: http://prsinfo.clinicaltrials.gov/) Clinical studies intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions. [Source: NCI] C71486.

Treatment - Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition. (Source: http://prsinfo.clinicaltrials.gov/.

Trial Status - The current stage or state of a clinical trial or study relative to other stages. Trial status types are listed below:

Trial Type - Code to represent an anticipated outcome for a clinical trial or research study that is the meaning or purpose for actions taken, thus guiding planned actions (e.g. efficacy, safety).

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Back to Top CTRP Acronyms

CTRP Acronym		Definition
caBIG		Cancer Biomedical Informatics Grid
caDSR		Cancer Data Standards Repository
CBIIT		Center for Biomedical Informatics and Information Technology (formerly known as the National Cancer Institute Center for Bioinformatics or NCICB)
CCB		Cancer Centers Branch
CCCT		Coordinating Center for Clinical Trials
CCR		Center for Cancer Research
CDE		Common Data Element
CDP		Cancer Diagnosis Program
CGH		Comparative Genomic Hybridization
CIP		CancerImaging Program
CTAC		Clinical Trials Advisory Committee
CTEP		Cancer Therapy Evaluation Program
CTRO		Clinical Trials Reporting Office
CTRP		Clinical Trials Reporting Program
CTWG		Clinical Trials Working Group
DCB		Division of Cancer Biology
DCCPS		Division of Cancer Control and Population Sciences
DCEG		Division of Cancer Epidemiology and Genetics
DCP		Division of Cancer Prevention
DCTD		Division of Cancer Treatment and Diagnosis
DEA		Division of Extramural Activities
DTP		Developmental Therapeutics Program
EBI		European Bioinformatics Institute
EVS		Enterprise Vocabulary Services
FDA		Food and Drug Administration
FDAAA		Food and Drug Administration Amendment Act (2007)
IDE		Investigational Device Exemption
IND		Investigational New Drug
IRB		Institutional Review Board
MedDRA		Medical Dictionary for Regulatory Activities
N/A		Not applicable
NCI		National Cancer Institute
NCICB		National Cancer Institute Center for Bioinformatics (now known as the Center for Biomedical Informatics and Information Technology or CBIIT)
NCTID		National Clinical Trial Identifier (ClinicalTrials.gov identifier)
OCE		Office of Communications and Education
OD		Office of the Director, NCI
PDQ		Physician Data Query
PI		Principal Investigator
PIO		Protocol Information Office
RRP		Radiation Research Program
SPORE		Specialized Program of Research Excellence (Now TRP: Translational Research Program)
TRP		Translational Research Program (Formerly SPORE)
URI		Uniform Resource Identifier
URL		Uniform Resource Locators
XML		Extensible Markup Language

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