Clinical Trial Incidents And How Insurance Responds

What’s in this article

You’ve just received notification of a serious adverse event, a batch contamination alert, or a protocol deviation that’s triggered a regulatory inspection. The immediate question isn’t whether you’re covered—it’s what happens next, who you notify, what evidence you need, and how the insurer actually responds.

This article walks through the most common clinical trial incidents sponsors face and shows you, step by step, how insurance claims unfold in practice. These aren’t theoretical examples—they’re based on real claims patterns underwriters see repeatedly. You’ll understand what triggers coverage, what insurers investigate, and what practical steps preserve both your position and your control.

Serious adverse event: participant injury from investigational product

A phase II diabetes trial participant develops severe hypoglycaemia requiring hospitalisation. Initial causality assessment suggests the investigational product is a possible cause.

How the incident unfolds

The clinical site reports the SAE to the sponsor within 24 hours. The sponsor’s pharmacovigilance team assesses causality, concludes it’s possibly related, and notifies the MHRA and REC within statutory timelines.

The participant’s family retains a solicitor who sends a letter of claim stating intention to pursue compensation for medical expenses, lost earnings and ongoing care costs.

What insurance response looks like for clinical trial incidents

The sponsor notifies their clinical trials insurer immediately, providing:

The SAE report with causality assessment.
Trial protocol and investigator brochure.
Participant informed consent documentation.
Medical records showing the hypoglycaemic event and treatment.
The solicitor’s letter of claim.

The insurer appoints a claims handler who commissions an independent clinical expert to review causation. The expert examines:

Temporal relationship: when did hypoglycaemia occur relative to dosing?
Dose-response: does severity correlate with dose level?
Alternative explanations: diet, concomitant medications, participant’s baseline diabetes control?
Dechallenge evidence: did glucose control normalise after stopping the investigational product?

The expert concludes causation is probable. The insurer engages with the participant’s solicitor to negotiate settlement covering medical costs, rehabilitation, lost earnings and general damages.

You remain in control of trial decisions—whether to continue dosing other participants, whether to amend the protocol, whether to notify investigators of new safety information. The insurer handles the financial claim and provides access to clinical and legal experts who advise you through each decision, but they don’t dictate trial management.

The key preservation step: document your causality assessment contemporaneously, notify promptly, and don’t speculate publicly about causation before expert analysis is complete.

A CRO monitoring visit identifies that consent forms at two sites were signed after participants began trial procedures. The deviation affects 12 participants.

How clinical trial incidents typically unfold

The CRO immediately reports the deviation to the sponsor. The sponsor notifies the MHRA and REC, classifying it as a serious breach of GCP. A corrective action plan is implemented: affected participants are re-consented, site staff are retrained, and monitoring frequency is increased.

Six months later, three participants claim they would not have participated had they been properly informed of risks. They seek compensation for distress and time lost.

What insurance response looks like for clinical trial incidents

The sponsor notifies their clinical trials insurer and sponsor legal liability insurer. The consent failure falls under sponsor legal liability because it relates to protocol oversight and regulatory compliance, not participant injury from the investigational product itself.

The insurer’s claims team investigates:

What information was missing or misrepresented in the consent process?
Did participants suffer actual harm or just procedural violation?
Were participants re-consented properly?
What does the corrective action plan demonstrate about the sponsor’s response?

The insurer appoints solicitors to respond to the claims. Two claims settle for modest sums reflecting distress and inconvenience but no physical harm. The third claim is defended successfully because evidence shows the participant was fully informed verbally even though the written consent was signed late.

Your rapid corrective action and transparent regulatory notification strengthen your defence. Insurers view prompt disclosure and systematic correction favourably—it demonstrates competence and reduces the risk of punitive findings in regulatory inspections or litigation.

Regulatory penalties for the breach itself are typically excluded from cover, but defence costs and participant compensation are covered under sponsor legal liability policies.

Investigational product contamination: microbial contamination in biologics trial

Quality control testing identifies bacterial contamination in three vials of investigational product at a phase III site. The batch was distributed to five sites across the UK.

How clinical trial incidents proceed

The sponsor immediately halts dosing across all affected sites and quarantines remaining vials. The MHRA and REC are notified. A root-cause investigation identifies a seal failure during the fill-finish process at the contract manufacturer.

Four participants who received potentially contaminated product are monitored closely. Two develop localised infections requiring antibiotic treatment and additional hospitalisation.

What insurance response looks like for clinical trial incidents

Multiple policies are potentially engaged:

Clinical trials insurance responds to participant injury claims.
Product liability (held by the manufacturer) may respond if the contamination arose from manufacturing defects.
Recall costs may be covered under sponsor first-party insurance or the manufacturer’s product recall policy.

The sponsor notifies their clinical trials insurer and provides:

SAE reports for the two participants with infections.
Root-cause investigation report from the manufacturer.
Batch records, fill-finish validation data and quality control test results.
Telemetry showing cold-chain integrity during transport.
Contracts showing the manufacturer’s indemnity obligations.

The insurer’s claims team investigates the chain of causation. Because the root cause is manufacturing failure, they pursue contribution from the manufacturer’s product liability insurer based on contractual indemnities.

The two participants’ claims settle covering medical costs, extended hospitalisation and general damages. The insurers negotiate allocation: the clinical trials insurer settles with participants promptly, then recovers a substantial proportion from the manufacturer’s insurer.

Your trial is protected by insurance, but you also have contractual recovery rights against the manufacturer. The practical consequence: document manufacturer contractual obligations clearly, require evidence of their insurance, and preserve all contamination investigation evidence.

Rapid response—halting dosing, quarantining product, notifying regulators—demonstrates duty of care and reduces the risk that injuries worsen or that additional participants are exposed.

Data breach: ransomware attack compromises participant data

A ransomware attack on the sponsor’s clinical data management system encrypts trial databases containing participant identifiable information. The attackers demand payment and threaten to publish data.

How clinical trial incidents, of a data breach unfolds

The sponsor’s IT team isolates affected systems and engages a cyber forensics firm to assess the scope. The breach affects 350 participants’ personal and medical data.

The sponsor notifies the ICO within 72 hours as required by GDPR, notifies affected participants, and notifies the clinical trials insurer and cyber insurance carrier.

What insurance response looks like

The cyber insurance policy responds to:

Forensic investigation costs.
ICO regulatory defence if enforcement action follows.
Participant notification and credit monitoring costs.
Crisis communications and legal advice.
Business interruption if trial operations are suspended.

The insurer appoints a cyber breach response panel including forensic investigators, data protection solicitors and crisis communications specialists. They advise the sponsor through each step:

Whether to pay the ransom (generally discouraged, but the sponsor decides).
How to communicate with participants, the ICO and trial sites.
Whether data has been exfiltrated or just encrypted.
Steps to prevent recurrence.

The ICO investigates and ultimately issues a reprimand but no financial penalty, citing the sponsor’s rapid response and transparent reporting. Several participants claim distress and anxiety; these claims are settled through the insurer.

You control operational decisions—whether to restore from backups, whether to suspend the trial temporarily, how to communicate with investigators. The insurer provides specialist expertise and covers financial costs, but you make the calls on trial continuity and participant communication.

The key preservation step: notify promptly, engage forensics before restoring systems (to preserve evidence), and document your response decisions contemporaneously.

Regulatory inspection failure: MHRA identifies systemic monitoring deficiencies

An MHRA inspection identifies that the sponsor’s oversight of CRO monitoring was inadequate—monitoring visit reports weren’t reviewed systematically and identified protocol deviations weren’t escalated.

How the incident unfolds

The MHRA issues a notice of non-compliance requiring corrective actions within 90 days. The sponsor implements systematic review procedures, retrains staff, and appoints an independent auditor to verify compliance.

Eighteen months later, a participant injured in the trial argues that the monitoring failure caused delayed identification of a safety signal, worsening their outcome. They file a claim against the sponsor.

What insurance response looks like

The sponsor notifies their sponsor legal liability insurer. The claim alleges that inadequate safety monitoring—a sponsor oversight failure—contributed to participant harm.

The insurer investigates:

Was there actually a safety signal that monitoring should have caught earlier?
What does the timeline show about when deviations were identified vs when they should have been?
Did the delayed identification materially affect the participant’s outcome?

The insurer appoints medical causation experts and monitoring specialists to assess whether earlier identification would have changed the outcome. If the expert opinion is that the outcome would have been the same regardless, the claim is defended. If causation is uncertain, settlement negotiations reflect the balance of probabilities.

MHRA penalties and enforcement costs for the regulatory breach itself are excluded from insurance. But claims arising from the breach—participant compensation, defence costs—are covered under sponsor legal liability.

The corrective actions you took after the inspection strengthen your position. Insurers and courts view systematic remediation favourably—it shows you took the finding seriously and reduced future risk.

Site negligence: investigator administers wrong dose to multiple participants

A site investigator misreads the protocol and administers twice the intended dose to five participants over three weeks before the error is identified during a monitoring visit.

How the incident unfolds

The CRO identifies the error, reports it to the sponsor, and the sponsor notifies the MHRA and REC immediately. All five participants are examined; three show elevated liver enzymes potentially related to the overdose.

Claims emerge from four participants. One experienced significant liver toxicity requiring hospitalisation and ongoing monitoring.

What insurance response looks like

Liability is potentially shared between sponsor (protocol clarity, site selection, oversight), CRO (monitoring frequency) and site (misreading protocol, failing to clarify dosing).

The sponsor’s clinical trials insurer is notified and begins investigating. The CRO’s professional indemnity insurer is also notified. The site’s medical malpractice insurer may be engaged depending on contractual arrangements.

The sponsor’s insurer takes the lead on participant claims because the sponsor holds primary legal liability. They then pursue contribution from the CRO and site based on contractual indemnities and proportional fault.

The investigation examines:

Was the protocol dosing section clear and unambiguous?
Did the site have adequate training on dosing?
Should monitoring visits have identified the error earlier?
Did the site seek clarification before dosing?

Settlement occurs with the sponsor’s insurer paying participants promptly, then recovering portions from the CRO’s and site’s insurers based on negotiated fault allocation.

Your participant-facing liability is covered, but you have rights to recover from other parties. The practical steps that preserve those rights: clear contracts with sites and CROs showing indemnity obligations, documentation of training provided, and monitoring visit records showing oversight frequency.

Good protocol design—clear dosing instructions, decision trees, worked examples—reduces the risk of site errors and strengthens your position if errors do occur.

Bottom line for Clinical Trial Incidents

Clinical trial incidents follow predictable patterns: participant injuries, contamination events, data breaches, regulatory compliance failures and site errors. Insurance responds to each differently based on causation, contractual allocation and policy triggers.

The practical lessons across all scenarios:

Notify insurers promptly. Late notification can prejudice coverage.
Preserve evidence immediately. Spoliation weakens both claims defence and recovery rights.
Document decisions contemporaneously. Reconstruction months later is less credible than real-time records.
Act transparently with regulators. Rapid disclosure and systematic correction strengthen your position.
Understand your contractual recovery rights. You may have multiple insurers involved with contribution disputes to navigate.

When clinical trial incidents occur, you remain in control of trial management decisions. Insurance gives you access to clinical experts, regulatory solicitors, forensics specialists and claims professionals who advise you through each step. They support your decisions; they don’t make them for you.

External Resources

MHRA Clinical Trial Deficiency Reports. Public data on inspection findings and regulatory non-compliance.
British Medical Journal (BMJ) – Clinical Trials Series. Peer-reviewed articles and case studies on trial incidents.
Schroll, J. B., Maund, E., & Gøtzsche, P. C. (2012). Challenges in coding adverse events in clinical trials: a systematic review. PloS one, 7(7), e41174. https://doi.org/10.1371/journal.pone.0041174

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