Building an Internal Quality Assurance Program

Abstract

Any academic medical center nurturing a research program must take practical steps to safeguard compliance. Instead of relying solely on pharmaceutical monitoring to preserve compliance, the establishment of an internal quality assurance (QA) system may be considered as an extra step toward meeting compliance goals. Commitment from upper levels of management can set up the audit program to be a key element of a Good Clinical Practice quality system within an organization. If internal QA is viewed as an essential, cohesive element of research programs, it would nurture constructive interactions between the research team and QA professional, thereby building higher standards of quality into the program.