Guidance for Industry: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.

摘要

Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high-quality studies. Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA. FDA's regulations require sponsors to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors are to conduct such monitoring and are therefore compatible with a range of approaches to monitoring (see section III) that will vary depending on multiple factors (see section IV.C).