Covers bodily harm to a subject from clinical trials or volunteer studies by sponsors, CROs and IRBs on a no-fault basis. A standard wording compliant with KGCP, ICH-GCP and MFDS guidelines.
N2N Insurance Brokerage does not represent any single insurer — it independently represents the client as an FSS-registered broker (Reg. No. 2026-012201). We compare the wordings, rates and service of AIG · Chubb · DB · Hyundai · KB · Meritz to propose the cover and price best suited to your risk. Each insurer's full wording is provided at application and binding.
Clinical trials liability insurance is no-fault cover that compensates bodily harm to a subject during a trial or volunteer study run by a sponsor, CRO (contract research organisation) or IRB (institutional review board), regardless of whether the investigator was at fault.
Under the MFDS's KGCP (Korean Good Clinical Practice) and ICH-GCP, cover is effectively required to run a trial, and the informed-consent form states that this insurance is in place. For multinational trials, simultaneous country-by-country cover is available through the Chubb Global Network.
Compensates subject bodily harm regardless of sponsor, CRO or IRB fault.
A wording compliant with MFDS guidelines and global standards.
Combined cover for Phase 1–4 trials plus volunteer studies.
Simultaneous cover for multi-country trials — managing country wordings together.
Pharma and biotech companies commissioning or sponsoring trials.
Contract research organisations and site-management organisations.
Institutional review boards and conducting institutions.
Human volunteer studies in health screening, exercise, nutrition, etc.
| Limit | USD 250K per subject / USD 5M per trial |
|---|---|
| Key endorsements | Multi-country simultaneous cover + follow-up compensation |
| Limit | KRW 100m per subject / KRW 500m per trial |
|---|---|
| Key endorsements | KGCP standard wording |
| Limit | KRW 50m per subject / KRW 200m per study |
|---|---|
| Key endorsements | Volunteer-study endorsement |
※ The above are general design examples; actual premium and limits may differ according to the risk profile of the business, past claims history and the insurer's assessment.
| Policy period | The trial period or 1 year, renewable |
|---|---|
| Payment | Single payment |
| Insurers | Chubb (dedicated Life Sciences team) · AIG |
| Channel | Individual consultation with our broker |
| Turnaround | 7–14 business days after protocol review |
If the insured event has already occurred at the time the contract is made, the contract is void. However, where the contract is void due to the company's intent or negligence, or where the company knew or could have known of the nullity before acceptance yet did not refund the premium, the company refunds the premium with interest at the policy-loan rate published by the Korea Insurance Development Institute, compounded annually, for the period from the day after payment to the day of refund.
The specific losses not covered (exclusions) are set out in each insurer's policy wording and product description; on this page, see the “Cover” tab(or the “Losses not covered” section) for the main exclusions. For other cover-specific grounds on which claims are not paid, please refer to the policy wording.
The company provides cover, in accordance with the policy, from the time it accepts the application and receives the first premium. Where the company accepts the application after receiving the first premium with it, cover also begins from the time the first premium was received.
The application must be completed by the policyholder, and the policyholder and the insured must sign it by hand. Failure to sign by hand may result in disadvantages regarding the validity of the contract. On an internet cyber-mall, an electronic signature may be used instead.
The policyholder has the right to be given and have explained the information needed about the product they wish to buy.
The insurer and N2N Insurance Brokerage must explain the important matters of the product to ordinary financial consumers.
When applying, the policyholder, the insured or their agent must disclose truthfully the facts they know regarding the questions in the application (including the questionnaire). Otherwise the claim may be declined or the contract cancelled. Where insurance is taken out by telephone or other means of communication, the duty is performed by answering the seller's questions, which are recorded, without a separate written questionnaire, so answers must be given with particular care.
If, after the contract is made, any of the following arises in respect of the subject-matter insured, the policyholder or the insured must notify the company in writing without delay and obtain endorsement on the policy.
The surrender value is the amount paid if the contract is cancelled early. Unlike bank savings, insurance combines risk protection and savings: part of the premium is paid out as claims to other policyholders who suffer accidents, and part covers the insurer's operating expenses, so the surrender value on early cancellation may be less than the premiums paid, or nil.
Under Article 59-4(1) of the Income Tax Act (special tax credit), for protection-type insurance taken out by an employee only, a tax credit of 12% of the premium paid (capped at KRW 1 million per year) is available. Tax matters may change with amendment or repeal of the relevant tax law.
Except as provided by law, the insurer and N2N Insurance Brokerage do not collect, use, inspect or provide personal data related to this contract — for its conclusion, maintenance and claim payment — without the consent of the policyholder, the insured or the beneficiary. However, for those purposes the insurer may, with the consent of the policyholder and the insured and in accordance with law, provide personal data to other insurers and insurance-related bodies.
The above is a summary and excerpt of the policy wording; for grounds on which claims are not paid and other details, please refer to the policy wording and product description.
Five pre-market trial categories — no-fault subject compensation applies
New-drug Phase 1 (safety), Phase 2 (efficacy) and Phase 3 (large-scale) trials. Proof of cover is effectively required at MFDS trial-plan approval.
Trials for device approval. An area where a separate compensation duty is imposed under the Medical Devices Act's trial standards.
IVD trials under the In-Vitro Diagnostic Medical Devices Act. The cover area for harm from test complications and misinterpretation of results.
Multi-country trials across the USA, EU and Asia. A territory-extension endorsement or a global umbrella wording is essential.
Post-market additional safety assessment (Phase 4), observational studies (real-world evidence), etc. Separate trigger conditions should be checked per wording.
In a biotech sponsor's Phase 1 trial, a subject suffered an unexpected adverse reaction. No direct fault of the investigator was proven, but under KGCP and ICH-GCP the trial sponsor bears a no-fault duty to compensate harm with a recognised causal link to the trial. When the wording responds, compensation is assessed for medical costs, lost income and permanent disability, and — with a territory-extension endorsement for a global trial — US and EU sites are covered under the same wording structure. This case shows that the sponsor's review of the wording at application is key to incident response.
Source: (General industry example) · Commercial insurance from the field #upcoming
Read the full analysis — the Phase 1 adverse-event compensation process (in progress) →The wording and structure points sponsors most often overlook
The two are more than 90% compatible, but there are operational differences in compensation procedure, required documents and notification timing. When applying ICH-GCP to global trials and KGCP to domestic ones, check that the wording satisfies both.
The base wording covers only trials within Korea. US and EU trial sites require a separate territory-extension endorsement or a global umbrella wording, and because US trials in particular carry high litigation risk and compensation cost, reviewing the per-territory limit and exclusion structure in advance is key.
Clinical trials liability is limited to subject harm at the pre-market trial stage. Adverse effects in ordinary patients from a drug marketed after the trial fall under the Drug Adverse-Reaction Relief scheme or the broader No-Fault insurance area, so covering the whole lifecycle requires designing the two wordings together.
The questions asked most when considering clinical trials liability cover
Under the Enforcement Rule of the Pharmaceutical Affairs Act and the MFDS's KGCP and device-trial standards, the trial sponsor bears a duty to compensate subject harm caused by the trial, and taking out insurance or an equivalent compensation arrangement is effectively essential. Proof of cover is required at MFDS trial-plan approval.
The primary party is usually the trial sponsor. A CRO may take its own wording through contractual liability-sharing, and an IRB may be separately covered for its review-and-approval responsibility. In multinational trials, it is usual for the global sponsor to design an umbrella wording covering all participating institutions.
The core scope is bodily harm to a subject during the trial (adverse reactions, complications, test complications, etc.). On the no-fault principle, cover is assessed once a causal link to the trial is shown, without proving investigator fault, and usually includes medical costs, lost income, permanent-disability and death compensation.
Clinical trials liability is limited to subject harm at the pre-market Cover is limited to subject harm at the trial stage. Adverse effects in ordinary patients from a marketed drug fall under the separate Drug Adverse-Reaction Relief programme or the broader No-Fault insurance wording area, and the boundary between the two is clearly drawn.
ICH-GCP is the international clinical-trial standard agreed by major regulators in the USA, EU and Japan, while KGCP is the MFDS's good clinical practice. The two are more than 90% compatible; multinational trials run on ICH-GCP and domestic ones on KGCP. Wordings are usually structured to satisfy both.
A Korean wording basically covers trials within Korea, and overseas trial sites such as the USA and EU need a separate territory-extension endorsement or a global umbrella wording. US trials in particular carry high litigation risk and compensation cost, so reviewing the per-territory limit and exclusion structure in advance is essential.
The insurer calculates it based on the trial phase (1–4), number of subjects, duration, whether the drug is new or established, territory, and past incident history. The exact premium and acceptance are confirmed after underwriting by insurers such as AIG, Chubb, DB, Hyundai, KB and Meritz.
