What clinical trial liability insurance covers, and what sponsors ask for first
If you're running a clinical trial in Ontario, you'll likely hear about insurance before anyone else asks about your product.
Before the first participant enrols
Sponsors, hospitals, and research ethics boards commonly want to see proof of coverage before a study starts enrolling. The reason is simple. If a participant is injured because of the study protocol or the product being tested, someone has to answer for it.
What the coverage responds to
Clinical trial liability insurance is designed for claims that arise from the study itself, usually the protocol and the investigational product. It is different from product liability, which applies once a product is on the market. A trial can be paused, a protocol can change, and a participant can be affected in ways a standard business policy never anticipated.
What sponsors and hospitals usually ask for
Expect requests for:
- A certificate or letter confirming coverage, naming the parties that need to be covered
- Limits that match the trial phase, participant numbers, and site list
- Confirmation that the policy responds to claims from participants at each site
- Consent documentation and how participants are informed about risks
The exact requirements differ by sponsor and site. Some university and health-research offices publish their insurance requirements for sponsored trials. Read those first, then compare them with your study agreement.
Questions to answer before you ask for a quote
- What is the trial phase?
- How many participants do you expect, and over what period?
- Where are the sites, and which institutions will be involved?
- Who is the sponsor, and what does the sponsor agreement say about insurance?
- Is the product a device, a diagnostic, or a therapy, and does it have regulatory approval for this use?
Ready to talk it through?
Send your details through the risk review form, or call Elia George at (905) 361-9292.
Coverage descriptions here are general information only and are not a binder, quote or guarantee of coverage. Policy terms, conditions, limits and exclusions govern. Availability is subject to insurer underwriting. Insure The Lab is a marketing initiative operated by Elia George, who is contracted with St. Andrews Insurance Brokers. Insurance products are offered through St. Andrews Insurance Brokers. Elia George is compensated by commission. See the St. Andrews commission disclosure.