Clinical Trial Insurance Unpacked: CTIMP, Non‑CTIMP and Device Trials

You’re placing insurance for a trial, reviewing a policy wording, or answering an investor’s question about what’s actually covered when a participant is injured. The answer depends on what you’re testing—medicinal products require CTIMP insurance with strict regulatory alignment, observational studies need non-CTIMP cover with different triggers, and device trials introduce mechanical and software risk that neither adequately addresses.

This article explains how each type of clinical trial insurance actually works: what triggers coverage, how claims are assessed, what underwriters scrutinise and where exclusions create gaps. It’s written from the underwriting perspective—what matters when policies are placed and claims are paid.

What is CTIMP insurance and when is it required?

CTIMP insurance covers liability to trial participants for injury or death arising from a Clinical Trial of an Investigational Medicinal Product.

It’s mandatory under UK law. The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) require sponsors to hold participant injury insurance before the first dose is administered. Without it, the MHRA won’t grant a Clinical Trial Authorisation and Research Ethics Committees won’t approve the trial.

The policy responds when a participant suffers injury or death that’s attributable to the investigational medicinal product or trial procedures. Causation is key—underwriters and claims handlers examine whether the harm arose from the trial intervention or would have occurred regardless.

What CTIMP clinical trial insurance typically covers:

• Injury or death caused by the investigational medicinal product.
• Injury arising from protocol-mandated procedures (biopsies, imaging, blood draws).
• Harm from protocol design defects that make the trial inherently unsafe.
• Costs of treating trial-related injuries.
• Compensation for pain, suffering and loss of earnings.

What clinical trial insurance typically excludes:

• Pre-existing conditions unrelated to the trial.
• Known side effects disclosed in informed consent where the participant accepted the risk.
• Harm caused by the participant’s non-compliance with trial requirements.
• Injury from approved standard-of-care treatments unrelated to the investigational product.

Underwriters price CTIMP insurance based on trial phase, participant numbers, product safety history, protocol complexity and the sponsor’s regulatory compliance track record. A phase I first-in-human trial attracts more scrutiny and higher premiums than a phase III trial with established safety data.

How does non-CTIMP insurance differ—and what does it actually cover?

Non-CTIMP insurance covers trials that don’t involve investigational medicinal products: observational studies, registry trials, surgical procedure studies, some early-phase device work and non-interventional research.

The regulatory burden is lighter—non-CTIMP trials don’t require MHRA authorisation, though they still need ethics approval from a Research Ethics Committee. Insurance isn’t legally mandatory, but sponsors carry it because participants, sites and funders expect it.

The coverage triggers differ. Non-CTIMP policies respond to harm caused by trial participation, not necessarily by a medicinal product. The risk profile skews toward procedural harm, data collection errors and participant burden rather than drug toxicity.

What non-CTIMP clinical trial insurance typically covers:

• Injury from study procedures (additional blood draws, imaging, questionnaires that cause psychological harm).
• Harm from protocol-related interventions (surgical techniques being studied, diagnostic procedures).
• Negligence in data collection or study conduct that causes participant harm.

What underwriters scrutinise when offering clinical trial insurance:

• Invasiveness of procedures. A study requiring bone marrow biopsies carries more risk than one analysing existing blood samples.
• Participant vulnerability. Trials involving children, pregnant women or cognitively impaired participants attract stricter underwriting.
• Observational vs interventional design. Pure observation has lower risk than studies requiring participants to change behaviour or undergo additional procedures.

Practical consequence: don’t assume a “non-CTIMP” label means simple or low-risk. Underwriters assess actual participant exposure, not regulatory classification.

What makes device trial insurance different—and harder to place?

Device trials introduce risk that doesn’t exist with pharmaceuticals: mechanical failure, software faults, human factors errors and long-term implant complications.

Underwriters treat device trials separately because the risk assessment is fundamentally different. With a drug, you’re modelling pharmacology, toxicity and biological response. With a device, you’re assessing engineering failure modes, software reliability, user error and post-market surveillance data.

What device clinical trial insurance typically covers:

• Injury from device malfunction during the trial.
• Harm from software errors in active devices (pacemakers, insulin pumps, diagnostic algorithms).
• Complications from implanted devices (infection, migration, rejection).
• Injury from inadequate instructions for use or training.
• Mechanical failure of diagnostic or therapeutic equipment.

What underwriters want to see when offering clinical trial insurance:

• Design controls and validation. Evidence of systematic design verification, risk analysis (ISO 14971) and validation testing. Underwriters want to see Failure Mode and Effects Analysis documentation.
• Post-market data. For devices with prior commercial use, complaint logs, field performance data and recall history matter more than preclinical testing.
• Human factors testing. Evidence that the device interface has been tested with representative users. Many device injuries stem from use errors, not technical failures.
• Software verification. For software-based devices, evidence of systematic testing, version control and cybersecurity controls.
• Implant-specific risk. For implantable devices, underwriters examine biocompatibility testing, sterilisation validation and long-term performance data.

Exclusions to watch for in clinical trial insurance policies:

• Known design defects. If you proceed with a trial knowing a design flaw exists, that’s typically excluded.
• Unapproved modifications. Changes to the device during the trial without proper validation can void cover.
• Off-label use beyond protocol. If investigators use the device in ways not covered by the protocol, exclusions may apply.

Practical consequence: device trial insurance is harder to place and often more expensive than equivalent CTIMP cover. Underwriters want engineering evidence, not just clinical protocols.

How do claims actually get assessed under each policy type?

Claims assessment differs fundamentally across CTIMP, non-CTIMP and device clinical trial insurance policies because causation standards and evidence requirements vary.

CTIMP claims: pharmacological causation

A phase II oncology trial participant develops liver toxicity. The question: did the investigational product cause it, or is it disease progression?

The insurer appoints clinical experts to review:

• Temporal relationship: when did toxicity appear relative to dosing?
• Dose-response: does severity correlate with dose?
• Dechallenge/rechallenge: did toxicity resolve when dosing stopped?
• Alternative explanations: disease progression, concomitant medications, pre-existing conditions?
• Comparator data: does the control arm show similar rates?

If causation is established, the claim proceeds. If alternative explanations are more plausible, it’s declined. Where causation is uncertain, settlement negotiations reflect the balance of probabilities.

Non-CTIMP claims: procedural harm

An observational study requires participants to undergo additional MRI scans. One participant suffers a contrast reaction causing renal impairment.

The insurer examines:

• Was the MRI protocol-mandated or standard care?
• Was contrast necessary for the study?
• Were contraindications screened for?
• Was informed consent adequate?

If the MRI was purely for research purposes and contraindications weren’t checked, the claim is covered. If it was standard clinical care unrelated to the study, it’s not.

Device claims: failure mode analysis

A participant in a cardiac device trial experiences device malfunction leading to arrhythmia and hospitalisation.

The insurer commissions engineering analysis:

• Device retrieval and examination: what physically failed?
• Telemetry and event logs: what does device data show?
• User error assessment: was the device used per protocol?
• Design review: was this a known or foreseeable failure mode?
• Manufacturing defect: was this unit defective or a systemic design issue?

If a design defect or manufacturing failure caused the malfunction, the claim proceeds. If user error or protocol deviation caused it, liability may be contested.

What about clinical trial insurance policies that try to cover everything—do they work?

Some insurers offer combined or hybrid policies claiming to cover CTIMP, non-CTIMP and device exposure in a single programme. These can work for sponsors running diverse trial portfolios, but require careful scrutiny.

What to examine in combined policies:

• Sub-limits. Does the policy have separate limits for device vs medicinal product claims? Aggregation across trial types can exhaust limits faster than expected.
• Exclusions. Hybrid policies often have broader exclusion language to accommodate diverse risk. Check whether specific device failure modes or drug classes are carved out.
• Claims triggers. Ensure the policy defines “injury” and “causation” in ways that work for your trial mix. Some policies use narrow pharmaceutical definitions that don’t fit device or procedural risk.
• Regulatory alignment. Combined policies must satisfy CTIMP regulatory requirements where applicable. Check that policy wording explicitly references CTIMPs and regulatory compliance.

Practical advice: hybrid policies suit sponsors with multiple concurrent trials across product types. For single-trial or single-product sponsors, dedicated CTIMP, non-CTIMP or device cover usually offers clearer terms and fewer coverage disputes.

How do underwriters actually price clinical trial insurance policies differently?

Underwriters assess CTIMP, non-CTIMP and device trials using distinct risk models.

CTIMP underwriting focuses on:

• Phase and prior safety data. Phase I first-in-human trials are priced at multiples of phase III trials with established safety.
• Participant numbers and dosing duration. More participants and longer exposure increase aggregate risk.
• Regulatory history. Sponsors with clean MHRA inspection records and no prior serious breaches get better terms.
• Safety monitoring robustness. Evidence of active Data Safety Monitoring Boards, clear stopping rules and rapid SAE reporting reduces premiums.

Non-CTIMP underwriting focuses on:

• Procedural invasiveness. Observational studies with minimal intervention get baseline pricing; studies requiring surgical procedures or high-risk diagnostics attract significant loadings.
• Participant vulnerability. Paediatric, pregnant or cognitively impaired cohorts increase premiums.
• Data handling risk. Studies involving sensitive data, genetic information or long-term follow-up raise GDPR and data breach concerns.

Device underwriting focuses on:

• Prior field performance. Devices with clean post-market surveillance and low complaint rates get favourable terms. Novel devices with no field history face substantial uncertainty loadings.
• Implant vs external use. Implantable devices carry long-tail risk (infection, migration, revision surgery years later) that external devices don’t.
• Software and cyber risk. Active devices with connectivity or autonomous decision-making face cyber and software failure risk that passive devices don’t.
• Regulatory class. Class III devices (high risk) are priced significantly higher than Class I or II devices.

Practical consequence: don’t assume equivalent trials get equivalent pricing. A 50-participant phase II drug trial and a 50-participant device trial with the same budget can have vastly different insurance costs.

Bottom line

Clinical trial insurance isn’t a single product. CTIMP insurance responds to medicinal product harm with regulatory compliance as a precondition. Non-CTIMP insurance covers procedural and observational study risk with lighter regulatory burdens. Device insurance addresses mechanical, software and human factors risk using engineering failure analysis.

Each type has distinct coverage triggers, exclusion patterns and claims assessment processes. Underwriters price them using separate risk models based on product type, participant exposure, regulatory history and prior field performance.

The practical implication: match your clinical trial insurance to your trial type. Don’t force a device trial into a CTIMP policy or assume a hybrid policy adequately covers both. Review policy wordings for specific exclusions, understand how causation will be assessed, and ensure regulatory compliance evidence is prepared for placement.

When incidents occur, the quality of your policy wording and the alignment between trial type and coverage determines whether claims are paid smoothly or disputed for months.

Reference reading

• HRA – Non-CTIMP Studies Guidance. Official UK guidance distinguishing CTIMP from non-CTIMP trials
• ISO 14971 – Medical Devices Risk Management. International standard for device risk management that underwriters reference