Essential Components of a Clinical Trial Agreement | Webinar Series
Clinical trials can involve significant risks and liabilities for research sponsors, investigators, and sites, as well as for study participants who may suffer injuries or adverse events as a results of their participation. Therefore, it is essential for those who are involved in drafting, reviewing, negotiating, or supervising the performance of clinical trial agreements to understand the legal and practical aspects of indemnification, subject injury, and insurance clauses. These clauses can determine who is responsible for paying for the costs of diagnosing, treating, compensating, or defending against claims arising from study-related injuries or damages and other risks including intellectual property infringement, violations of the privacy of subjects and other third parties, the appropriateness of study protocols, and future publications and representations made about study protocols and results. While not frequently litigated, indemnification clauses often provide the framework for addressing who will pay particular costs resulting from claims related to the clinical trial.
This webinar will review the types and scope of indemnification clauses in clinical trial agreements, provide strategies and challenges for negotiating indemnification clauses, and review the sources of subject injury clauses. We will also discuss strategies and challenges for negotiating subject injury clauses, the types and scope of insurance clauses, logistics and procedures for making or responding to a claim for indemnification for subject injury coverage, and issues related to Medicare Secondary Payor rules and equity for the non-insured for those trials for which CMS allows payment of a device or other costs.
Knowledge Level: All Levels
Individual Registration:
Member Price: $99
Non-Member Price: $165