Points to Consider When Implementing a Clinical Quality Assurance Program

Abstract

Implementation of an effective quality assurance (QA) program for good clinical practices (GCPs) requires a full understanding of applicable regulations and an upper management commitment to provide training for personnel and to modify company procedures as deficiencies are discovered. This paper will address differences in the approach depending on the limits set by the scope of the clinical program and the extent of transferred obligations to outside vendors. Global clinical programs introduce country-specific differences that must be effectively addressed. The effectiveness of QA programs for GCPs is dependent on the degree of understanding upper management has of these differences and its commitment to a team approach to effective resolution. Three scenarios are presented.