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Medical Devices, Pharmaceuticals

Financial Disclosure by Clinical Investigators

About the Course

This online course provides a summary of Title 21 of the Code of Federal Regulations (CFR) Part 54 entitled “Financial Disclosure by Clinical Investigators.” This course discusses which financial arrangements must be disclosed, as well as investigator and sponsor responsibilities when disclosing financial information. Topics in this eLearning course include: Requirements, Responsibilities, and FDA Evaluation. After completing this online training, learners will be able to identify the types of financial arrangements that must be disclosed and recognize how FDA evaluates the submitted financial information and the actions they may take if it is inadequate.