Clinical Trials Liability Insurance

Clinical Trials Liability Insurance

Clinical Trial Liability Insurance (CTLI) basically covers legal liability arising out of lack of care, negligence resulting in injury or death of the subject. Insufficient/improper disclosure and conflict of interest may also become subject matter of suit. This policy generally covers legal expenses also. Territorial limit is prescribed in the policy. The policy can be single trial policy or it may be multi-trial policy covering several trial of the policyholder. The policy is on “Claim made” basis. Cover can be extended for post-trial liabilities up to 60 months. For the purpose of rating the most important aspect to look into is the track record of the sponsoring company and others involved in conducting the trial. The company must establish and maintain a policy of adherence to the required clinical trials protocol and must not stray from safety norms. Fulfillment of informed consent rules must be ensured. Parties to the clinical trial must sign clinical trial agreement for strict adherence to the protocol and to take care of other concerns.

INDUSTRY NEWS