What insurance is required by a clinical trial agreement?

A clinical trial agreement (CTA) between sponsor, CRO, and investigative site routinely includes an insurance schedule with three distinct coverage tiers. Sponsor-side: clinical trial liability scaled to study phase and enrollment, naming the site, principal investigator, and institution as additional insureds. CRO-side: professional liability and errors-and-omissions at $2 million to $5 million, naming the sponsor as additional insured. Site-side: institutional general liability and professional liability for the site's own scope of work.

The negotiation question that drives the most pushback is whether the CRO's E&O responds to claims arising from its own monitoring errors, source document review failures, or protocol deviation reporting failures - even if the underlying injury falls within the sponsor's clinical trial liability. Sponsors increasingly demand explicit CRO E&O coverage for these scenarios; CROs whose E&O policies have exclusions for clinical trial work cannot satisfy a strict CTA read.

CTAs with European sites trigger additional requirements: ICH E6(R3) GCP compliance verification, EU GDPR-aligned cyber for subject data, and EU-domiciled insurance for sites in some member states. A US-domiciled CRO with US-only insurance cannot directly satisfy these requirements without an EU-extension placement.