QA Q&A Corner

Abstract

Several misconceptions prevail regarding what constitutes “quality” and a “quality program.” When designing a quality program, one must distinguish between quality, quality system, and compliance. These terms are used pervasively throughout the clinical research arena, and they are often erroneously used interchangeably. Editor’s Note: For this issue, the usual author of this column, Michael R. Hamrell, PhD, RAC, RQAP-GCP, CCRA, is pleased to present Dr. Walters-Herring, a professor and expert compliance consultant in clinical research, as an invited contributor to address the role and importance of quality programs in clinical research.