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FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
Frequently Asked Questions
A. What is ClinicalTrials.Gov?
ClinicalTrials.gov is the largest clinical trial registry & results database, it’s run and overseen by The National Institutes of Health (NIH). Main functions include trial registration, trial updates, and results reporting. There are over 330,000 studies that are registered with over 40,000 project that have results reporting.
B. Why is it important to register my clinical trial?
The main purpose of this registry is to disclose key information of clinical trials to the general public. Other purposes include:
− Ethical obligation to study participants who volunteer to join clinical trials. − Evidence Based Medicine – Offers transparency, scientific validity,
replicability of the research and results, eliminates publication bias, EMB for
policymakers
− Aligns with federal laws: FDAAA-801, 42 CFR 11, 45 CFR 46 116(h) - posting
of an approved ICF on CT.gov, 21 CFR §50.25(c) - CT.gov statement included
in ICF
− Publication Requirement - ICMJE policy (registration and data sharing plan) − Serves as a resource to patients, physicians, researchers, granting agencies,
and policy makers
− Other – NIH policy, CMS policy, NCI policy, WHO policy
− Other – Funding Source requirements – Gates Foundation, Global Alliance,
Welcome Trust
C. Howdoresearcherssubmitarequestforuserlog-infromPRS administrator?
For institutions/organizations with a PRS organization administrator(s), researchers can submit a request for user log-in from the PRS by submitting a PRS Administrator Contact Request Form.