PhRMA BioResearch Monitoring Committee Perspective on Acceptable Approaches for Clinical Trial Monitoring

Abstract

The integrity of clinical research data is critical for making sound regulatory decisions regarding the approval and use of medications. Equally important is the safeguarding of human subjects in clinical trials. A key element in the generation of high-quality data and protection of research participants during clinical research is sponsor monitoring of the clinical investigator site. This article provides the current thinking of the PhRMA BioResearch Monitoring Committee on acceptable approaches to clinical trial monitoring, taking advantage of risk-based decision making and modem technological tools. The intent is to provide flexibility in approaches—given the broad diversity of types of clinical research—while maintaining high standards for quality and integrity. The PhRMA BioResearch Monitoring Committee believes such approaches are applicable to all types of clinical research, regardless of who is sponsoring or conducting the research (industry, academia, or government agency).