42 CFR Part 11 Flashcards
(ClinicalTrials.gov)
What is 42 CFR Part 11?
A regulation that establishes registration and reporting requirements for clinical trials on ClinicalTrials.gov.
What is the purpose of 42 CFR Part 11?
To ensure public access to information about clinical trials and their results, promoting transparency and accountability in research.
What types of studies must be registered?
Applicable Clinical Trials (ACTs), including:
- Drug and biologic trials regulated by the FDA.
- Device trials that are controlled, interventional, and FDA-regulated.
- Pediatric post-market surveillance studies ordered by the FDA.
What key information must be included in trial registration?
Study title and summary.
- Study design, interventions, and outcome measures.
- Eligibility criteria and recruitment status.
- Contact information and study location.
When must clinical trials be registered?
Within 21 days of enrolling the first participant.
What is required for results reporting?
Summary results must be submitted within 12 months after the trial’s primary completion date.
Data should include:
- Participant flow
- Baseline characteristics
- Outcome measures and statistical analyses
- Adverse event information
What is the ‘Primary Completion Date’?
The date when the last participant completes data collection for the primary outcome.
What penalties exist for non-compliance with 42 CFR Part 11?
Civil monetary penalties.
- Possible suspension or termination of NIH grant funding.
- Public notices of non-compliance on ClinicalTrials.gov.
What is the role of the Responsible Party in 42 CFR Part 11?
The sponsor or designated investigator must ensure accurate registration and timely result reporting.
Why is 42 CFR Part 11 important?
It improves research transparency, allows public access to clinical trial information, and helps prevent selective reporting of outcomes.
