Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring." This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies.