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TL;DR

A research site network carries the liability the sponsor’s agreement leaves behind, multiplied by every location and every sponsor. The sponsor generally covers protocol-related injury through a contractual indemnity that excludes the site’s own negligence. Everything else is the network’s program: professional liability that actually covers research, general liability rated for clinical work, cyber for participant data, and EPLI and workers’ compensation in every state, all tied to a location schedule that keeps up with openings and acquisitions.

Site groups · SMOs · Multi-location

Many sites, many sponsors. One program has to answer all of them.

A single research site can manage its insurance one agreement at a time. A group with locations in several cities cannot. Each new site, sponsor, and lease adds a requirement, and the program that started as one clinic’s policies rarely keeps pace.

This page is for the operator of the network. For a single site reading one sponsor agreement, see clinical trial site insurance.

Request the reviewAudit a CTA indemnity clause

The network program

Five lines, and where each one breaks at scale.

Line
What it answers
Where it breaks
Professional / medical liability
Negligence, consent, and protocol-deviation claims against the entity, investigators, and coordinators.
Research exclusions; coordinators and contracted investigators not listed as insureds.
General liability
Premises injury and third-party bodily injury not arising from professional services.
Rated as a general office, with a professional services exclusion.
Cyber and privacy
Breach response, notification, and regulatory defense for participant data.
Limits sized to a clinic, not to the records held across every study.
EPLI
Employment claims from coordinators, nurses, and staff across states.
Acquired staff and new states not reflected in the application.
Workers' compensation
Staff injury, including needlestick and specimen handling.
States missing from the policy; Texas opt-out decisions that conflict with contracts.

01 · Investigators and coordinators

Professional liability has to name the people who do the research.

Most claims against a site allege something a person did: consent obtained badly, an eligibility criterion missed, a dose given wrong. The professional liability policy has to cover the entity and every person doing that work, including coordinators, research nurses, and contracted investigators who are not employees.

Two checks matter. First, the research language: some medical liability forms limit or exclude clinical investigation. Second, contracted investigators: their own malpractice policy may not cover research, and the network's policy may not list them. Either gap leaves the person and the network exposed on the same claim.

02 · The sponsor's policy

The sponsor covers the protocol. It does not cover the site's mistakes.

Site staff are rarely insureds under the sponsor's trial policy. What they have is a contractual indemnity in the CTA, which the sponsor's policy may fund. International GCP describes that indemnity as excluding claims arising from malpractice or negligence, and many CTAs go further, carving out protocol deviations and failure to follow written instructions.

So the sponsor responds to injury from the product or a correctly performed procedure. The allegations a plaintiff actually makes against a site land on the network's own policy. Treat the sponsor's indemnity as a second layer for a narrow set of claims, not as the site's cover.

03 · CTA terms across sponsors

Many sponsors, many insurance clauses, one program.

Each sponsor sends its own template with its own limits, additional insured requests, notice windows, and survival periods. Signed one at a time, they drift: one asks for a higher professional limit, another for cyber, a third for coverage that survives several years after close-out.

Keep a register of every active CTA's insurance and indemnity terms. Build the program to the strictest current requirement, decide in advance what you will accept and what you will push back on, and remember that one aggregate is shared by every study across every location.

04 · New and acquired locations

The location schedule is the policy.

Networks grow by opening sites and buying them. Each new address and each new legal entity has to be added as a named insured and scheduled location, on every line. Automatic coverage for new locations, where it exists, is usually limited in time and conditioned on reporting.

Acquisitions add a claims-made problem. The acquired site's past studies are covered only by tail on its old policies or by prior-acts coverage on yours with a matching retroactive date. Settle which before closing, and update the CTA counterparty names so certificates match.

05 · A failure seen in practice

Office-rated general liability does not fit a clinical operation.

A pattern we see in site groups: general liability written as if the business were a general office, often with a professional services exclusion. On paper it looks complete. In practice the site doses participants, draws and ships specimens, and stores investigational product, and the policy describes none of it.

The result is a policy that may not respond to bodily injury from the work and fails the leases and CTAs it was bought to satisfy. The fix is classification that matches the operation, with professional and general liability written to meet each other rather than leave a gap.

The rest of the program

Data, people, and leases across locations.

Cyber and HIPAA. Sites hold identifiable health information for every participant, often across several sponsor systems. HIPAA permits research disclosures under defined conditions and requires notice to affected individuals after a breach of unsecured information. Size cyber to the records the network holds, and check sponsor CTAs for data-handling and cyber requirements.

EPLI and workers’ compensation. Each state brings its own employment law and its own compensation rules. Texas lets most private employers choose whether to carry workers’ compensation, but sponsors and landlords often require it. List every state on both policies, including states added by acquisition. More on EPLI for research staff.

Leases. Every landlord sets its own terms: additional insured status, waiver of subrogation, minimum limits, and property cover for improvements. A network with leases in several cities needs those terms tracked by location, just like CTAs.

Frequently asked

Common questions from site networks and SMOs

Are our coordinators and investigators covered by the sponsor's clinical trial policy?

Usually only for injury caused by the investigational product or a correctly performed protocol procedure, and usually through the sponsor's contractual indemnity rather than as an insured under the policy. International GCP expects that indemnity to exclude claims arising from the site's malpractice or negligence. Consent failures, protocol deviations, and dosing errors come back to the site's own professional liability.

Does each location need its own policies?

Not necessarily. Most networks are better served by one program with every operating entity as a named insured and every address on the location schedule. What matters is that the schedule is current, that each entity named in a CTA or lease is actually insured, and that certificates show the right legal name.

What happens to coverage when we acquire a site?

The acquired site's past work is insured by its old claims-made policies only if someone buys tail or the new program picks up prior acts with a matching retroactive date. Without one or the other, claims from studies run before closing can fall between the two programs. Check this before closing, not at the next renewal.

Why is an office-rated general liability policy a problem for a research site?

Because it describes a different business. Research sites dose participants, draw and process specimens, store investigational product, and in some cases run overnight units. An office classification, often with a professional services exclusion, may not respond to bodily injury from those activities, and it frequently fails the lease and CTA requirements it was bought to meet.

Do Texas site groups have to carry workers' compensation?

Texas lets most private employers choose whether to carry it, and employers without coverage must report that to the state. Many sponsor agreements and leases still require it, and a network with locations in other states will face mandatory rules there. The decision should be made once for the network and checked against every contract.

What should a site network send for a review?

The location list with legal entities, current policies, the lease insurance sections, and a sample of CTA insurance and indemnity clauses from your main sponsors. That is enough to map the program against what the contracts require.

Next steps

Keep going.

Related deep-dives

Go deeper on the specific clauses and decisions that show up most.

Authoritative references

Primary sources cited on this page

Site network review

Send the location list. We will map the program against every contract.

Send a protocol synopsis from a typical study, your site list with legal entities, and your current policies, plus sample CTA and lease insurance clauses if you have them. A specialist returns a location-by-location read of where the program meets your contracts and where it does not.

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