Sponsor Education of Clinical Investigators in the Clinical Research Process

Abstract

Since the advent of FDA's Bioresearch Monitoring Program, the pharmaceutical industry has carefully reviewed and revised procedures related to the conduct of clinical research. This review process has occurred with vigor over the past 10 years, particularly with regard to the monitoring of clinical studies by sponsor companies. Despite these efforts, problems in clinical research continue and the level of regulatory noncompliance at the sites of clinical investigation appears to remain static.