Clinical Quality Management Program (CQMP)

The Clinical Quality Management Program (CQMP) was established to develop and implement a comprehensive, standardized clinical research monitoring program to replace the Quality Assurance Monitoring Review Standards for Clinical Research Policy. The Clinical Quality Management Program pilot CRUs received training in July 2018. The program focuses on helping CRUs develop Clinical Quality Management Plans for all consenting and prospective studies that are not externally or independently monitored and that do not have ongoing approved monitoring plans. These plans focus on identifying key quality indicators, like the informed consent process, participant eligibility, and safety reporting that may affect study conduct. A designated trained Quality Management (QM) reviewer will conduct regulatory file and participant chart reviews at predetermined time points.

For questions regarding the CQMP, please e-mail CQMP@duke.edu.