ABSTRACT
The quality assurance unit as established by the Good Laboratory Practices regulations serves as a means by which management ensures that the facilities, equipment, personnel, methods, practices, records, and controls used in a study are in conformance with the regulations. Based on the broad scope of quality assurance responsibilities, both in preclinical and clinical research, research quality assurance can also provide senior research management with an unbiased evaluation of the efficiency of systems and procedures used throughout research operations. Finally, the research quality assurance unit may serve as an educational resource for medical monitors and clinical research associates insofar as it can point out commonly encountered problems in monitoring and work with the medical monitors to try to solve these problems. While research quality assurance is mandated by regulation, it can be a very powerful management tool for both clinical research personnel and senior management.
