| The Food and Drug Administration Code of Federal Regulation (FDA CFR) and International Conference of Harmonisation Good Clinical Practices Guidelines (ICH GCP Guidelines) provide the clinical investigator (CI) with the quality standards to follow when conducting clinical trials. The quality standards, however, do not provide CIs with the tools necessary to apply these standards to achieve or sustain quality or to manage compliance issues. It is important for the CI to develop a quality management system (QMS) to ensure proper tools are in place, such as standard operating procedures (SOPs), training, and corrective and preventative action (CAPA) programs, to manage all aspects of the clinical trial at the CI institution. This paper analyzes the FDA CFR, applicable FDA guidance documents, and ICH GCP Guidelines to outline the regulatory requirements and the application of ISO 9001: 2008 (ISO 9001) principles to develop a CI QMS. |
