GCP Duties for Reviewing Clinical Trial Insurance

Under the updated UK clinical trial regulations effective 28 April 2026, sponsors and delegated organizations must carry out thorough checks of insurance arrangements rather than relying on Research Ethics Committee (REC) confirmation. The REC only verifies that insurance exists; it does not assess whether the coverage is appropriate for the study. Sponsors are accountable for ensuring sufficient insurance or indemnity to address liabilities linked to trial design and oversight. Research sites must also secure coverage for risks arising from their trial activities. CROs and Phase 1 units must independently review the adequacy of insurance, assess exclusions, and document these evaluations in the Trial Master File (TMF), signed by qualified personnel. Any significant change to insurance terms is considered a substantial, study-wide amendment and must be submitted for REC and study-wide review. Where exclusions affect participant eligibility, sites must implement safeguards to prevent the inclusion of individuals lacking adequate coverage.

11-12-2025