17 Jan 2023
Contract Research Organization Agreements
Learn how to negotiate and draft agreements between drug or medical device companies (sponsors) and contract research organizations (CROs) to design, monitor, and audit clinical trials. Sponsors routinely retain CROs to handle administrative and oversight responsibilities for clinical trials. The CRO agreement sets the ground rules for the sponsor-CRO relationship. Read this practice note to understand CRO fundamentals, sponsor and CRO responsibilities, and key elements of the CRO agreement.
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Use this template to obtain informed assent for clinical trials when the subjects are children or minors. Under federal law, children are those persons who have not yet reached the legal age for consent to treatments that are a part of research. This age can vary by jurisdiction. When your clinical trial involves children or minors, you must obtain the child's assent as well as the permission of the child's parent or legal guardian. This template includes guidance, drafting notes, and alternate clauses. - Medical Treatment and Informed Consent State Law Survey
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