Clinical trials liability insurance responds to bodily injury claims brought by human subjects who participate in a device study. It is a separate placement from products liability, and sponsors are generally required to carry it before a site will enroll a single patient.
The requirement is contractual as much as regulatory. Institutional review boards, site agreements, and sponsor obligations all reference insurance, and the specific terms vary by site and by country. This page covers what the coverage responds to, what sites and IRBs typically require, and how to structure a program across a multi-site study.
What Clinical Trials Liability Covers
The policy responds to injury sustained by an enrolled subject arising from the investigational device or the study procedures, along with the cost of defending those claims. Coverage is normally arranged per study rather than as a blanket corporate policy.
Sites almost always require additional insured status for the institution and its personnel, and they require a certificate before activation. Those requirements are specific, and a certificate that does not match the language in the clinical trial agreement will hold up site activation.
What Sites And IRBs Require
The insurance schedule inside the clinical trial agreement is the controlling document. It sets the limits, the additional insured wording, and the notice provisions. Some institutions also require subject injury or compensation provisions that go beyond what a standard policy contemplates.
Requirements are not uniform. Academic medical centers, community sites, and international institutions each carry their own standards, and a program built to satisfy the first site may not satisfy the fifth.
Structuring Coverage Across A Multi-Site Study
Limits are usually arranged per study with an aggregate across the trial. As sites are added mid-study, the program has to be endorsed to reflect them, and each new site brings its own certificate and additional insured requirements.
The transition out of the trial matters as much as the trial itself. Clinical trials coverage does not convert into the commercial program, and claims from study subjects can arrive after the study closes. That is what makes the tail arrangement worth deciding before the study ends rather than after.
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