Financial Disclosure by Clinical Investigators

This 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 course include: Requirements, Responsibilities, and FDA Evaluation. After completing this course, 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.

After this course learners will be able to recognize the types of financial arrangements that must be disclosed and the requirements for proper financial disclosure for covered clinical studies. recognize the responsibilities of the applicant (or sponsor) and the clinical investigator. identify how fda evaluates the submitted financial information and the actions they may take if it is inadequate.