Indemnification In Clinical Trial Agreements

Make sure, as a sponsor or organization representing a sponsor in the negotiations, that your compensation clause only compensates those who are actually involved in the study. For example, it may be useful to compensate an affiliated hospital that plays a tangible role in the study, such as providing an institution and staff (for example. B nurses) for the facility. However, if there are other affiliated hospitals in the same network that are not directly involved in the study, the language should not be included to expand the sponsor`s obligation to cover any other institution. In this case, it is industry practice to incorporate a language that explicitly limits the scope of the obligation to companies or associated entities “conducting the study.” However, a compensation clause does not prevent a third party (for example. B a subject in a clinical trial) to sue “B.” Compensation – The ATC`s compensation service should be reviewed: lead investigators should discuss all aspects of the clinical trial with their contract agent before negotiations begin. The involvement of the UCI faculty in the development of protocols and/or the organization of studies creates additional problems that both parties must tackle completely. It is therefore necessary to negotiate different or additional contractual terms. Under this exception, the examiner is not entitled to compensation for the damage caused by his own negligence. While the proponent must compensate the examiner for the losses he may suffer as a result of the negligence of the promoter (for example. B if the drug itself is “defective”), the promoter would be legally liable for the damage, even in the absence of a compensation clause.

In other words, if the member or scientific staff for whom he or she is legally responsible would make an error in prescribing or administering a drug during the clinical trial or during the course of testing in the course of the study, the member and his scientific staff might consider that the association would defend them in a subsequent legal proceeding and pay any compensation that might be awarded to a participant in the study on the basis of a court decision or procedure. THE teachers and UCI staff are involved in numerous clinical study projects to study drugs or test devices.

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