Clinical Quality Management plans and review tools

The following tools are used to assist QM reviewers in developing Clinical Quality Management Plans and conducting both the regulatory and participant chart reviews. These tools are available in a Word document for convenience but must be completed in the Clinical Quality Management (CQM) Database in REDCap as part of the plan development and study review process. Access to the CQM Database is provided to personnel who complete the QM reviewer training.

CQM Plan creation tools
Regulatory file review tools
Participant chart review tools
RCA and CAPA plans

The Duke Office of Scientific Integrity provides training and support with Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) planning, upon request. This support is not limited to clinical research being conducted under the CQMP Policy. Please send a message to the mailbox to request help for your research team.

Review closeout request forms