Quality assurance operations: good clinical practices.

Abstract

The pharmaceutical industry sponsor bears the ultimate responsibility for the verification of all clinical data submitted to the FDA in support of a New Drug Application (NDA). The author provides an overview of a systematic approach to providing quality assurance for all clinical data collected in the course of human trials with research compounds. This systemic approach includes such features as: Standard Operating Procedures Manuals, the development of a quality assurance function within the organization, detailed documentation for all monitoring activities, careful assessment of all clinical research data collected, and an emphasis on preventive measures that can be introduced to assure the quality of subsequent research data.