Quality assurance in phase II and III studies.
Quality control participates in the clinical research process by providing an auditing function to evaluate compliance with company standards and regulatory requirements. Additionally, quality control support is provided for the proper manufacture and release of clinical supplies and a day-to-day involvement in the clinical operation for the review of selected clinical documents, interactions with regulatory agencies, and the creation/review of clinical systems. The quality of the clinical study is the result of the combined efforts of the clinical personnel that perform the study and the support groups such as quality assurance.
Wood
D J
DJ
G. D. Searle & Co., Skokie, Illinois 60077.
D002985:Clinical Protocols / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D017277:Drug Approval / Q000379:methods; D006801:Humans; D008485:Medical Audit; D017712:Peer Review, Research / Q000592:standards; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control