Clinical trial disclosure
Clinical trial disclosure requirements are creating a secondary compliance burden for Trade and Geopolitical Risk teams, particularly where cross-border data sharing, export-controlled research, and foreign government-sponsored trials intersect with sanctions regimes. The U.S. Food and Drug Administration's 2023 final rule on clinical trial data submission under 42 CFR Part 11, combined with oversight activity from the European Medicines Agency and the U.S. Department of Health and Human Services Office for Human Research Protections, means disclosure obligations now touch supply chain provenance, foreign principal relationships, and technology transfer in ways most risk functions have not fully mapped. Cresthaven tracks every relevant agency action across this intersection so compliance teams are not reconstructing the picture from scratch.
Watch
- 42 CFR Part 11 final rule: deadline compliance for foreign-site trial registrations
- EMA transparency policy on trials conducted in sanctioned-country research facilities
- HHS OHRP guidance on foreign government co-sponsorship disclosure requirements
- Dual-use research of concern disclosures flagged in ClinicalTrials.gov filings
- BIS export control overlap with biologics trial data shared to APAC affiliates
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