Insurance Review in Phase 1 Clinical Trials

28th November 2025

Insurance Review in Phase 1 Clinical Trials

Summary: A new blog post explains that from 28th April 2026, updated regulations will require sponsors of Clinical Trials of Investigational Medicinal Products (CTIMPs) — including Phase 1 trials — to submit evidence of insurance or indemnity with their ethics application.  Sponsors must ensure adequate cover for liabilities arising from trial design and management. Research sites (especially non-NHS ones) must also verify that the insurance is appropriate, with no unjustified exclusions, and document those checks in the Trial Master File. NHS sites will undergo a UK-wide review of sponsor insurance; any changes to the insurance during a trial will count as a substantial amendment and must be re-submitted for review. 

Link: Insurance Review in Phase 1 Clinical Trials – MHRA Inspectorate

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