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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. 

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.

Key Contacts

CTgov@fredhutch.org for assistance with ClinicalTrials.gov and FDAAA regulations

CTreporting@fredhutch.org for assistance with CTRP and NCI reporting requirements

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.

graphic showing study type on CTRP versus Clinicaltrials.gov

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)

If your Cancer Consortium study is not registered by CRS or an outside sponsor and you need to register it, contact the ClinicalTrials.gov Administrator in CRS for an individual ClinicalTrials.gov account.

Reports from CTRP are used in submitting progress reports to the NCI Office of Cancer Centers (OCC) for the P30 CCSG that evaluate a cancer center’s annual progress.

  • Interventional trials: CTRP Data Table 4 reporting for interventional trials started after October 1, 2017 for non-competing CCSG applications and after May 25, 2020 for competing CCSG applications. 
  • Observational studies: NCI transitioned to CTRP DT4 for observational studies after October 1, 2021 for non-competing applications.
  • Ancillary-Correlative studies: These studies are reported to NCI using the NCI OCC DT4 format.

NIH Grantee Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov:
https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

FDA Amendments Act (FDAAA 801) & the Final Rule Registration and Results Requirements:
https://clinicaltrials.gov/ct2/manage-recs/fdaaa

ClinicalTrials.gov Registration and Results Reporting Guided Tutorials:
https://prsinfo.clinicaltrials.gov/tutorial/content/index.html#/

How to Submit Study results and Adverse Events on ClinicalTrials.gov:
https://clinicaltrials.gov/ct2/manage-recs/how-report

ClinicalTrials.gov Support Materials:
https://clinicaltrials.gov/ct2/manage-recs/resources

ICMJE Information (Medical Journal Publishing Requirements):
http://www.icmje.org/about-icmje/faqs/clinical-trials-registration

HHS Final Rule News Release (September 16, 2016):
https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public

NCI Clinical Trials Reporting Program:
https://www.cancer.gov/about-nci/organization/ccct/ctrp

NCI Office of Cancer Centers:
https://cancercenters.cancer.gov