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.
CTgov@fredhutch.org for assistance with ClinicalTrials.gov and FDAAA regulations
CTreporting@fredhutch.org for assistance with CTRP and NCI reporting requirements
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.
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.
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