Trial Insurance and Indemnity Section
ICH E6(R3) treats insurance/indemnification as a distinct sponsor responsibility subject to applicable requirements. A concise section can identify coverage arrangements while leaving participant-care and compensation procedures to their appropriate related documentation.
A Trial Insurance and Indemnity section states the insurance or indemnification arrangements that apply to trial conduct and identifies the governing sponsor, contractual, or regulatory framework.
Key details
Important caveats
Scope Boundary
Insurance, indemnity, injury treatment, and participant compensation are jurisdiction- and contract-dependent. Do not present regulatory guidance as legal advice or duplicate the separate ancillary/post-trial care and harm-compensation discussion.
Further guidance
Content
State whether trial insurance or indemnification applies, who provides it, what agreements or policies govern it, and where authoritative details are maintained when relevant.
Purpose
Make relevant risk-transfer and institutional protection arrangements transparent without inventing legal guarantees.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification