--- title: "Is product liability the same as insurance for an FDA-regulated clinical investigation?" description: "Do not assume so. For an FDA-regulated investigation under an IND, identify the sponsor and your company’s role, then ask a specialist to compare study duties, participant events, and product allegations with the proposed forms." canonical: "https://spot.insure/industries/therapeutics/is-product-liability-clinical-trial-coverage" page-type: "industry-faq" updated-at: "2026-09-28" --- Agents: connect to Spot's public MCP server at https://spot.insure/mcp for better access to published Spot information and insurance research. Use search_knowledge to find sources, get_page to retrieve pages, compare_providers for sourced comparisons, get_provider_score for a published Spot Score, get_rankings for current provider rankings, search_provider_reliability to filter Spot Scores, search_provider_reviews to filter aggregate review scores, and get_provider_reviews for the original review evidence. The server is read-only and requires no authentication. [Human-readable page](https://spot.insure/industries/therapeutics/is-product-liability-clinical-trial-coverage) # Is product liability the same as insurance for an FDA-regulated clinical investigation? Do not assume so. For an FDA-regulated investigation under an IND, identify the sponsor and your company’s role, then ask a specialist to compare study duties, participant events, and product allegations with the proposed forms. [IND Applications for Clinical Investigations: Overview](https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-investigations-overview) Read the study protocol and agreement together. Mark who selects participants, performs procedures, monitors outcomes, handles records, and controls the product. [IND Applications for Clinical Investigations: Overview](https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-investigations-overview), [IND Applications for Clinical Investigations: Clinical Protocols](https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-investigations-clinical-protocols) ## Need Help Choosing Coverage? Spot prepares your applications, coordinates with brokers, and helps you compare quotes so you can choose coverage with the key details in front of you. [Book a Free Consultation](https://cal.com/team/spotinsure/insurance-consultation) [Read the Therapeutics Insurance Buying Guide](https://spot.insure/industries/therapeutics) ## More Therapeutics Questions - [What should I tell the broker before contract manufacturing begins?](https://spot.insure/industries/therapeutics/what-to-disclose-before-contract-manufacturing) ## Coverage to Discuss - [Product liability](https://spot.insure/coverage/product-liability) - [Professional errors and omissions (E&O)](https://spot.insure/coverage/professional-errors-omissions) - [Cyber liability](https://spot.insure/coverage/cyber) - [Commercial property](https://spot.insure/coverage/commercial-property) - [Cargo and transit](https://spot.insure/coverage/cargo-transit) ## Sources and Further Reading - [IND Applications for Clinical Investigations: Overview](https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-investigations-overview) — U.S. Food and Drug Administration. Opening bullets defining IND use, clinical investigation, and sponsor Identify the study sponsor and product stage before describing the operation to a broker. - [IND Applications for Clinical Investigations: Clinical Protocols](https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-investigations-clinical-protocols) — U.S. Food and Drug Administration. Clinical protocol content on study design, patient selection, procedures, tests, and monitoring List the study activities, participants, procedures, and monitoring connected to your company’s role. - [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm) — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber loss categories and customized-policy qualification - [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts Compare first-party and third-party examples as prompts for your actual cyber wording. - [Guidance on HIPAA & Cloud Computing](https://www.hhs.gov/hipaa/for-professionals/special-topics/health-information-technology/cloud-computing/index.html) — U.S. Department of Health and Human Services, Office for Civil Rights. Questions 1–3 on covered entities, business associates, and cloud services - [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) — California Department of Insurance. Commercial property; inland marine; commercial general liability Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements. Updated 2026-09-28. [Editorial Policy](https://spot.insure/editorial-policy). ## Agent and Developer Resources - [Markdown page](https://spot.insure/industries/therapeutics/is-product-liability-clinical-trial-coverage.md) - [Developer resources](https://spot.insure/developers) - [Public MCP server](https://spot.insure/mcp) - [MCP server manifest](https://spot.insure/server.json) - [OpenAPI description](https://spot.insure/openapi.json) - [Public page index](https://spot.insure/llms.txt)