Clinical Trials Reporting
CTRP & ClinicalTrials.gov
Government agencies and the International Committee of Medical Journal Editors have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinically directive trials are publically available. As members of an NCI-designated Comprehensive Cancer Center, Cancer Consortium investigators are responsible for ensuring registration of their interventional trials with ClinicalTrials.gov. CRS staff registers most investigator-initiated trials with ClinicalTrials.gov; other trials are registered by the investigator, the industry sponsor or the coordinating center. CRS registers all interventional trials with NCI’s Clinical Trials Reporting Program (CTRP).
The National Library of Medicine's ClinicalTrials.gov website offers information for a wide range of diseases and conditions. Registering trials with ClinicalTrials.gov is a federal requirement for certain trial types, and is necessary for any trial if you intend to publish research results in a medical journal. Registration must be complete prior to enrolling the first study participant.
NCI's Clinical Trials Reporting Program (CTRP)
CTRP is a comprehensive database containing all NCI-funded clinical trials. NCI supports all Cancer Consortium trials through the Cancer Center Support Grant (the Core grant).
How CRS Assists Investigators
Clinical Research Support will register most investigator-initiated, interventional trials with CTRP and ClinicalTrials.gov following initial SRC approval, and will continue to update these registries whenever modifications to the protocol or changes in recruitment status are approved by the IRB. CRS also helps investigators determine whether they are required to report results and adverse events data in the CT.gov database, providing guidance and support as needed.
Which trials does Clinical Research Support register on ClinicalTrials.gov and CTRP?
Clinical Research Support registers trials that meet all of the following criteria:
- Trial has received SRC approval from FHCRC/UW Cancer Consortium
- Trial will be undergoing IRB review at FHCRC/UW Cancer Consortium
- Cancer Consortium (FHCRC or UW) is the Sponsor/Coordinating Center
- Trial is Interventional (any phase) [Excluding ancillary or correlative trials]
- Trial documents (protocol and consent) are managed by Clinical Research Support for IRB submission [cancer-related trials]
- Trial is Investigator Initiated
Who should register a trial on ClinicalTrials.gov if it will not be registered by Clinical Research Support?
Industry-sponsored trials and multi-center trials coordinated by another institution should be registered on ClinicalTrials.gov by the industry or institutional sponsor; however, the PI is ultimately responsible for determining that registration requirements are met.
How do I register my trial on ClinicalTrials.gov?
If your Cancer Consortium study is not registered by Clinical Research Support or by an outside sponsor and you need to register it, contact the ClinicalTrials.gov Administrator in Clinical Research Support (206-667-4520) for an individual ClinicalTrials.gov account.
Where can I find more information?
- Medical Journal Publishing Requirements: For more information about the Medical Journal Editors registration requirement, see the 2007 ICMJE editorial entitled "Clinical Trial Registration: Looking Back and Moving Ahead" (June, 2007)
- FDA Amendments Act (Section 801) Requirements: http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa
- FDA Amendments Act: For more information about the FDAAA, see http://grants.nih.gov/ClinicalTrials_fdaaa/
- FDA Amendments Act: Frequently Asked Questions: http://grants.nih.gov/ClinicalTrials_fdaaa/faq.htm
- Reporting Results and AEs: For more information about reporting basic results in ClinicalTrials.gov, see: http://chestjournal.chestpubs.org/content/136/1/295.full?sid=5bf6541b-d31a-4bc2-9460-35a4a3172186
- Reporting Results and AEs: Presubmission checklist for reporting results: http://prsinfo.clinicaltrials.gov/pre-submission-checklist.pdf
- General Info: Call Clinical Research Support at 206-667-4520 and ask to speak with the ClinicalTrials.gov Administrator
- ClinicalTrials.gov reporting timeline