Clinical Trials Reporting
CTRP & ClinicalTrials.gov
Government agencies and the International Committee of Medical Journal Editors (ICMJE) 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 and the 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 within 21 days of enrolling the first study participant (note that ICMJE requires registration on ClinicalTrials.gov prior to enrollment of first participant). Records must be updated within 30 days of a change in recruitment status or completion date and other updates must occur at least every 12 months. Trial records must be verified for accuracy every 6 months and summary results must be submitted within 12 months of the trial’s primary completion date.
Clinical Trials Reporting Program (CTRP)
NCI’s CTRP is a comprehensive database containing all NCI-supported interventional clinical trials open to accrual as of January 1, 2009. NCI supports all Cancer Consortium trials through the Cancer Center Support Grant (CCSG Core grant). Trials must be submitted prior to enrollment of the first patient, amendments within 20 days of IRB approval, status changes within 30 days of the change, and other updates least every 12 months. Trial records must be verified for accuracy every 6 months. Accrual information must be reported quarterly to CTRP.
How Clinical Research Support Assists Investigators
Clinical Research Support will register most investigator-initiated, interventional trials with ClinicalTrials.gov and CTRP 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. Other trials are registered in ClinicalTrials.gov by the investigator, the industry sponsor or the coordinating center. CRS submits accrual information to CTRP quarterly and also help investigators determine whether they are required to report results and adverse events data on ClinicalTrials.gov. You are welcome to review and verify the ClinicalTrials.gov data at any time. Contact the CRS ClinicalTrials.gov Administrator to request changes or to initiate verification of your trial record.
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 Fred Hutchinson/UW Cancer Consortium
- Trial will be undergoing IRB review at Fred Hutchinson/UW Cancer Consortium
- Cancer Consortium (Fred Hutch or UW) is the Sponsor/Coordinating Center
- Trial is Interventional (any phase)
- 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.
The International Committee of Medical Journal Editors (ICMJE) requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. “The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering.” (Source: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html)
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?
NIH Grantee Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov:
FDA Amendments Act (FDAAA 801) & the Final Rule Registration and Results Requirements:
How to Submit Study results and Adverse Events on ClinicalTrials.gov:
ClinicalTrials.gov Support Materials:
ClinicalTrials.gov Protocol Data Element Definitions:
ClinicalTrials.gov Results Data Element Definitions
ICMJE Information (Medical Journal Publishing Requirements):
HHS Final Rule News Release (September 16, 2016):
Call Clinical Research Support (206-667-4520) and speak with the ClinicalTrials.gov Administrator