TR EN
Discuss Your Risk
Home › Clinical Trials Liability Insurance
Clinical Trials — TITCK Compliant Cover

Clinical Trials Liability Insurance:
Sponsor, CRO & Investigator Site Cover

Interventional clinical trials in Turkey typically require insurance as part of TITCK authorisation and Ethics Committee approval — the specific obligation depends on study classification, type and risk level under the Klinik Araştırmalar Yönetmeliği. We arrange sponsor liability, CRO cover, no-fault participant compensation and multi-centre trial programmes aligned with ICH GCP standards and Turkish regulatory requirements.

Request Trial Cover → +90 444 83 84
SEDDK Licensed Insurance & Reinsurance Broker Independent — no insurer ties TITCK & Ethics Committee compliant Multi-market competitive placement
Regulatory Context

TITCK Requirements & Ethics Committee Obligations

In Turkey, interventional clinical trials on human subjects are regulated by TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency). For interventional trials within the scope of the Klinik Araştırmalar Yönetmeliği (Article 2), TITCK typically requires the sponsor to provide evidence of adequate insurance before a trial may commence. Additionally, the relevant Ethics Committee (Etik Kurul) — whether a hospital ethics committee or the central Clinical Research Ethics Committee — will require a copy of the insurance certificate as a condition of its approval. Specific requirements depend on the study's TITCK classification, research type, and risk level.

Mandatory Condition Precedent

For interventional clinical trials within the scope of the Klinik Araştırmalar Yönetmeliği (Article 2), insurance is a key requirement for TITCK authorisation and Ethics Committee approval under Article 54. The insurance requirement under Article 54 does not apply to low-risk scientific studies expressly exempted under that Article. Under Article 2(2), observational studies fall outside the scope of this Regulation; this does not preclude obligations that may arise under other applicable legislation. Sponsors should verify the applicable obligations with TITCK and the relevant Ethics Committee before commencement. The policy should remain in force for the duration of the trial and for a specified extended period thereafter — commonly one to three years — to address adverse effects that may not become apparent during the active trial period.

ICH GCP Alignment

The International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines establish the global standard for clinical trial conduct. Turkish regulations incorporate ICH GCP principles, and insurers active in this market require that trials are conducted in full compliance with the approved protocol and ICH GCP. Significant protocol deviations are exclusion grounds in most clinical trials liability policies.

Cover Structure

Sponsor, CRO & Investigator Site — Who Needs Cover?

Sponsor Liability

The sponsor bears primary legal responsibility for the trial. Sponsor liability policies cover legal liability to participants for injury or death arising from trial procedures, including no-fault compensation.

CRO Liability

Where a Contract Research Organisation conducts the trial on behalf of the sponsor, the CRO's own liability exposure — particularly for activities it has taken full responsibility for — may require separate or additional cover.

Investigator Site

Individual hospital or clinic sites where procedures are conducted carry their own liability exposure. Site-level cover or inclusion as additional insured under the sponsor's policy must be confirmed.

No-Fault Compensation

Compensation payable to participants who suffer injury as a result of trial procedures, without requiring proof of negligence — an ethical and often regulatory requirement.

Policy Trigger: Injury During Trial vs. Long-Term Adverse Effects

Clinical trials liability policies typically cover injury that occurs during the trial or is attributable to the trial's procedures, but the timing of when adverse effects become apparent may vary considerably. A participant receiving an investigational medicine may not experience adverse effects until months or years after the last dose. The policy's extended reporting period — the time after trial completion during which claims may still be notified to the insurer — must be adequate to capture this tail risk. Underwriters assess this tail on the basis of the therapy's mechanism of action and the nature of the investigational product.

Condition Precedent — Ethics Committee Approval: Most clinical trials liability policies include Ethics Committee approval as a condition precedent to cover. This means the trial must have been approved by the relevant Ethics Committee in accordance with applicable law, and the trial must be conducted in accordance with that approval. A trial conducted without proper ethical approval, or materially in breach of it, may not be covered.
Exclusions

Key Exclusions in Clinical Trials Liability Policies

  • Intentional or deliberate deviation from the approved protocol
  • Injury arising solely from risks that were clearly disclosed in the informed consent form and accepted by the participant
  • Fraudulent data, concealed results or research misconduct
  • Known adverse effects of the investigational product that were concealed from the ethics committee or regulatory authority
  • Liability assumed under contract beyond standard legal liability
  • Injury to participants in countries not specified in the policy schedule

Frequently Asked Questions

Is clinical trial insurance compulsory in Turkey?
For interventional clinical trials within the scope of the Klinik Araştırmalar Yönetmeliği (Article 2), insurance is a key requirement under Article 54. TITCK typically requires evidence of adequate cover before a trial commences, and the Ethics Committee also requires it as a condition of approval. The insurance requirement under Article 54 does not apply to low-risk scientific studies expressly exempted under that Article. Under Article 2(2), observational studies fall outside the scope of this Regulation; this does not preclude obligations that may arise under other applicable legislation. Sponsors should verify applicable obligations with TITCK and the relevant Ethics Committee before commencement.
Can a CRO rely on the sponsor's clinical trials policy?
This depends on the policy wording and the contractual arrangement. Some sponsor policies extend cover to named CROs as additional insureds. Where the CRO has substantial delegated responsibilities or its own negligence is the primary cause of harm, a dedicated CRO liability policy is advisable. CROs operating independently for multiple sponsors should always maintain their own policy.
How are multi-centre clinical trials structured for insurance?
The most common approach is a global master policy issued to the sponsor, with country-specific endorsements where required by local regulation. In Turkey, TITCK may require a local policy or endorsement confirming Turkish law jurisdiction. The broker coordinates coverage across all sites to ensure no gaps between the master policy and local requirements.
What are the typical exclusions in clinical trials liability policies?
Common exclusions include: intentional or deliberate deviation from the approved protocol; known and accepted risks that the participant acknowledged in the informed consent form (where injury arises solely from a risk disclosed as inherent to the procedure); fraudulent data or results; injury arising from use of a placebo as the control arm where this is properly disclosed; liability assumed under contract beyond legal liability; and risks known before the trial commenced and deliberately concealed from the ethics committee or regulatory authority.
What is no-fault participant compensation?
No-fault compensation provides payment to trial participants who suffer injury or death from trial procedures, without requiring proof of sponsor or investigator negligence. It reflects the ethical principle that participants who accept experimental risk in the public interest should not bear the financial consequences of trial-related injury. Ethics committees frequently require this as a condition of approval.

Related Coverage Lines

General Liability Third-party bodily injury and property damage liability for pharmaceutical and healthcare businesses. D&O Insurance Directors and officers liability cover for pharmaceutical and biotech company executives. Employers' Liability Workplace injury liability for research and clinical trial site employees in Turkey.

Browse all terms: Insurance & Reinsurance Glossary →