Insurance Review in Phase 1 Clinical Trials

The new UK regulations for clinical trials will take effect on 28 April 2026. For clinical trials of investigational medicinal products (IMPs), the research ethics committee (REC) application must include any document providing evidence of insurance to cover the sponsor's or investigator's liability (i.e., proof of insurance, a guarantee, or a similar arrangement).

What are the GCP responsibilities for insurance review?

During recent good clinical practice (GCP) inspections, several instances were identified in which Contract Research Organizations (CROs) and Phase 1 Trial Organizations did not perform an adequate check of the insurance coverage for the trial because they assumed the REC had reviewed the coverage's suitability. However, the REC's review only determines that coverage exists. Sponsors are responsible for ensuring that they have adequate insurance or indemnity to cover potential liabilities arising from the design and management of the clinical trial. Additionally, research sites must make arrangements for insurance or indemnity to cover potential liabilities arising from their conduct of the clinical trial.

Any relevant change to the insurance arrangements constitutes a substantial, study-wide, reviewable amendment (modification from 28 April 2026) and must be notified to the REC and a study-wide reviewer for review. Checks for the acceptability of the coverage and the impact of any exclusions should be documented and signed by a suitably trained and experienced individual. These documents should be filed in the Trial Master File (TMF).

If exclusions mean certain individuals would not be covered if they participated in the trial, robust arrangements should ensure they are not included. This is usually accounted for in the clinical trial inclusion/exclusion criteria, but research sites should be prepared to make additional arrangements where necessary. These checks demonstrate the CRO's and Phase 1 trial organizations' due diligence in ensuring that the insurance arrangements are adequate and sufficiently cover the participant population and investigational medicinal products (IMPs) being administered.

For more information, please see the MHRA Inspectorate Blog on the Insurance Review in Phase 1 Clinical Trials.