Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring." This guidance is intended to assist 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. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities when conducting investigational new drug (IND) or investigational device exemption (IDE) studies.