Clinical Trial Insurance

Clinical Trial Insurance

If you are involved in clinical trials then there are 3 types of insurance cover that you should consider:

  1. Clinical trial cover on a no-fault liability basis. This is the insurance cover that is required by the Ethics Committee. It is referred to as ‘no-fault’ cover because it is triggered to respond to a claim by harm/injury suffered by a trial volunteer as a direct result of their participation in that trial. This means that it is not necessary for a volunteer to prove any kind of fault in order to successfully claim under this policy. Cover is intended for the participants of the trial who may suffer injury as a result of their participation in the trial. It is effectively a products’ liability type of insurance for harm caused to volunteers by the ‘product’ that is being clinically tested.

Cover can be structured to provide an overall limit for the trial or a limit for the trial with sub-limits per volunteer.

  1. Depending on the phase and type of trial, you would also need to ensure that all the healthcare practitioners who are involved in the administration of the trial have medical malpractice insurance in place.

In the event that a patient suffers harm and it is established that, for example, a doctor was negligent and administered an incorrect dose to the volunteer, then this will be a medical malpractice claim. The clinical trial insurers who may initially have responded to the claim before the cause of the injury was evident, will seek a right of recourse against the practitioner. It is therefore important that medical malpractice insurance is obtained for all healthcare professionals involved in the trial.

  1. If you are a clinical research organization or involved in the administration and collation of data for a trial, you need to have professional indemnity insurance in place. If you, for example, do not administer the trial correctly or you fail to ensure that the protocol is correctly followed or your fail to collate the trial data accurately, this could result in the trial having to be redone at great cost and a sponsor or other affected party may seek compensation from you for the loss that they have suffered as a result of your alleged professional negligence.

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Clinical Trial Insurance

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