Clinical trial disclosure
Clinical trial disclosure in Healthcare & Life Sciences is under simultaneous pressure from the U.S. Food and Drug Administration, the European Medicines Agency, and the U.S. Department of Health and Human Services, each operating distinct registration and results-reporting mandates that do not fully align with one another. The FDA's 42 CFR Part 11 requirements under FDAAA 801 set hard deadlines for ClinicalTrials.gov submission, while EMA's Clinical Trials Regulation 536/2014 runs a parallel timeline through CTIS that many sponsors are still operationalizing. Compliance teams are currently reconciling these dual obligations at the protocol level, not waiting for enforcement cycles to force the issue.
Watch
- FDAAA 801 results submission deadlines: 12-month clock post-primary completion date
- EU CTR 536/2014 transition: mandatory CTIS submission for all trials by January 2025
- HHS Office for Human Research Protections consent form posting requirements under 45 CFR 46
- FDA draft guidance on expanded access disclosure and its interaction with IND reporting obligations
- EMA transparency policy revisions affecting redaction standards for published trial data
Recent material activity in Healthcare & Life Sciences
Active monitoring in place across Healthcare & Life Sciences. Material developments related to clinical trial disclosure will appear here as they are published.