Indemnification Clinical Trial Agreement

Indemnification Clinical Trial Agreement

The University of California is self-insured and will retain appropriate insurance for the duration of the contract to cover its compensation obligations. The university cannot cover sponsorship fees; This is why the university requires a minimum down payment of 10 to 20% of the total expected cost for the execution of the contract. If a project has significant start-up costs, the university may require a higher upfront payment. Compensation is a contractual agreement between the parties, in which one party, the unscathed party, undertakes to protect the other party, the party compensated, from damages or losses caused by a third party and likely to occur to the party unscathed. It is important to understand that compensation protects the compensated party from third-party claims against it, not the claims of the compensated party against the compensated party. 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.» The same concepts apply to compensation by a site to the sponsor of the study. Many sponsors will seek similar or reciprocal compensation rights for third-party losses or claims arising from the institution`s particular behaviour. As for the sites mentioned above, they want to think about who they include as an compensated party, while the sponsor will want to consider who should be compensated.

As a general rule, this allowance is limited to the sponsor and its executives, directors, employees and agents, but may also include the CRO, retained by the sponsor for the completion of the study.



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