Clinical Quality Assurance

Abstract

The Quality Assurance section has the responsibility for assessing all clinical trials conducted by the Division of Medical Affairs (DMA) for compliance with applicable regulations and procedures, and adherence to the protocol. The Quality Assurance section reviews protocols and case report forms, audits internal study files, audits the clinical stockroom, audits data review and computer entry, participates in review of New Drug Applications (NDAs) and audits the sites of clinical studies. Workshops are also conducted to update Medical Monitors and Clinical Research Associates (CRAs) with results of audits, changes in federal regulations and in DMA procedures Auditing functions are performed in accordance with current and proposed regulations. The Food and Drug Administration (FDA) compliance Programs for Sponsors, Monitors and Clinical Investigators are used as guides in conducted audits. The mechanics of performing internal and external auditing will be examined.