Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations; Public Workshop

Streszczenie

The Food and Drug Administration (FDA, we) is announcing the following pubic workshop entitled "Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations." This public workshop is convened by Duke University's Robert J. Margolis, MD, Center for Health Policy and supported by a cooperative agreement with FDA. The purpose of the public workshop is to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring.