Clinical Trial Agreements Toolkit
This Toolkit is brought to you by AHLA's Academic Medical Centers and Teaching Hospitals; Life Sciences; and Regulation, Accreditation, and Payment Practice Groups.
- May 27, 2022
The Clinical Trial Agreements (CTA) Toolkit is designed to assist health lawyers with understanding and negotiating clinical trial agreements between industry sponsors and academic medical centers in instances where the industry party is the sponsor of a study involving an investigational drug. The CTA Toolkit is divided into 17 sections that represent key provisions of a CTA and is designed to provide the ideal provisions from both the industry-sponsor and academic medical center-clinical trial site perspective, as well as the reasoning behind those positions. The Toolkit also provides an overview of the business importance of each of these sections; relevant federal, state, or local laws; case law; international laws; other directives and resources; and operational considerations.
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