Clinical Trial Registries
Clinical Research Support (CRS) provides expertise in federal regulations and policy that govern reporting requirements in ClinicalTrials.gov and NCI's Clinical Trials Reporting Program (CTRP). CRS staff work with Consortium investigators and their staff to ensure registration, accrual reporting, and record maintenance.
As members of an NCI-designated Comprehensive Cancer Center, Cancer Consortium investigators are responsible for maintaining compliance in ClinicalTrials.gov and CTRP.
Key Contacts
CTgov@fredhutch.org for assistance with ClinicalTrials.gov and FDAAA regulations
CTreporting@fredhutch.org for assistance with CTRP and NCI reporting requirements
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 publicly available.
Federal Registry Requirements
ClinicalTrials.gov
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.
- Summary results must be submitted within 12 months of the trial’s primary and study completion dates.
- For studies subject to the revised 2018 Common Rule, a copy of the informed consent must be uploaded to ClinicalTrials.gov after the study closes to accrual and no later than 60 days following the study 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 and observational studies open to accrual as of or after January 1, 2018. 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.
A summary of registry reporting requirements can be found at: CTRP & ClinicalTrials.gov Reporting Timeline
Frequently Asked Questions
CRS will register most cancer-focused investigator-initiated, interventional trials with ClinicalTrials.gov and CTRP following initial SRC approval. Additionally, cancer-focused investigator-initiated observational studies will be registered in CTRP following IRB approval. Other trials are registered in ClinicalTrials.gov by the investigator, the industry sponsor, or the coordinating center.
