Description
This course covers Overview of 21 CFR Part 54 Financial Disclosure and Part 11 Electronic Data Signatures. This course’s main topics are financial disclosure, electronic records, and electronic signatures under FDA’s 21 CFR Part 54 and Part 11. These topics are applicable to drug, device, and biologic studies. Required by Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. Part 11 describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.
