Clinical Trial (Professional Liability) Insurance

Key Feature

This policy can be taken by Sponsor, Clinical Research Organization (CRO), Institution or investigator(s) either jointly or severally Clinical Trial (Professional Liability) Insurance covers

Liability arising out of Personal damages
Liability arising out of Material damages
Liability arising out of Damages arising from breaches of data protection.

Cost of expert evaluations and reports.
Other insurance benefits like
Default interest
Mitigation
Expert, Legal, Court, Arbitration, and Commission Costs etc.

Coverage

Clinical Trial (Professional Liability) Insurance covers Liability arising out of
Personal damages
Liability arising out of Material damages
Liability arising out of Damages arising from breaches of data protection
Cost of expert evaluations and reports.
Other insurance benefits like
Default interest
Mitigation
Expert, Legal, Court, Arbitration, and Commission Costs etc.

Exclusion
Personal damages and a deterioration of the existing state of health which would have occurred or persisted even without participation in the clinical trial.
Personal damages that occurred because the trial subject deliberately, or apparently deliberately, contravened the express instructions of the people in charge of carrying out the clinical trial.
Compensation for punitive damages.
Damages arising from substances/formulations or preparations listed by the insurer (the insurance company). These substances/formulations or preparations must be listed by name in the "Insurance certificate for the attention of the ethics committees". Should contraceptive drugs be used as the trial drug or as a compulsory co- medication in the context of a clinical trial, any damages attributable to these contraceptives shall be covered.
Personal damages to a patient in the control group, insofar as they are attributable to the application of a Drug product that has already been licensed for this indication. However, this does not exclude claims for personal damages attributable to a breach of the obligation to exercise due care by the policyholder or a third party commissioned by it to carry out the clinical trial.
Personal damages to a patient that do not exceed a certain degree of adverse reactions that are to be expected from the trial drug according to the current state of medical knowledge, insofar and to the extent that comparably serious damages could have occurred if the patient had undergone a standard therapy to treat his illness.
Personal damages to a patient that do not exceed a certain degree of adverse reactions that are to be expected from the trial drug according to the current state of medical knowledge, in the case of illnesses that ordinarily have a fatal outcome and insofar as no standard therapy exists to treat that illness.