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The course examines law and regulation pertaining to the initiation of research projects involving human and animal subjects by both universities and manufacturers. It examines the pertinent government regulations, guidance documents and enforcement initiatives forming the framework for the conduct of clinical trials and focuses upon the practical aspects of clinical trial contracting, application of regulatory guidelines, quality system compliance and corresponding documentation requirements. The course will provide experience in drafting and negotiating clincal trial contract provisions, addressing publication rights, intellectual property ownership, indemnification and confidentiality.
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