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.
Clinical Quality Management Plan Policy
The Clinical Quality Management Plan Policy outlines the type of studies and frequency of review for studies that will require monitoring under the CQMP.
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.
- Clinical Quality Management Plan Template
- Clinical Quality Management Plan Template Instruction Sheet
- Regulatory File Review Tool
- Regulatory File Review Tool Instruction Sheet
- Participant Chart Review Tool
- Participant Chart Review Tool Instruction Sheet
Clinical Quality Management Plan Complexity Level and Regulatory File Review Frequency
- Study Type Examples: Prospective Phase I–III interventional procedure, device, and/or drug studies (novel product or indication) and all studies under an IND or IDE with the FDA.
- Frequency of Regulatory File Review: At least quarterly (every three months)
- Study Type Examples: Behavioral intervention, complex observational or sample collection studies that are more than minimal risk. This includes FDA approved drugs, devices, or biologics used for their approved indication.
- Frequency of Regulatory File Review: At least bi-annually (every six months)
- Study Type Examples: Externally-funded studies using procedures generally considered to be minimal or low-risk, such as blood sample collection, imaging (not using sedation), questionnaires, and behavioral surveys (unless determined exempt by the IRB and thus, not subject to the policy)
- Frequency of Regulatory File Review: At least annually (once per year)
Clinical Quality Management Plan Complexity Level and Participant Chart Review Frequency
Please consult with your QM reviewer and/or the CQMP with any questions related to the study’s complexity level or the frequency of participant chart reviews or regulatory file reviews. Regulatory file reviews must be completed at the frequency indicated above based on the Institutional Approval date. Participant chart reviews must be conducted at the frequency indicated above based on the date of first enrollment.
Clinical Quality Management Program QM Reviewer Training
The CQMP is now offering monthly training sessions for QM reviewers. At each training session, we will review:
- CQMP Overview & Terminology
- CQMP Policy & Plan Creation
- QM Workflow, Tools, & Reports
- Conduct a sample QM Review
Please e-mail the CQMP at CQMP@duke.edu with your name, title, and the session you would like to attend.
Training will take place in Erwin Square DOCR Conference Room 1038 on the following days:
- Monday, August 26, 2019 | 1:00 - 4:00 pm
- Monday, September 30, 2019 | 1:00 - 4:00 pm
- Monday, October 28, 2019 | 1:00 - 4:00 pm
- Monday, November 11, 2019 | 1:00 - 4:00 pm
- Monday, December 16, 2019 | 1:00 - 4:00 pm
- Monday, January 27, 2020 | 1:00 - 4:00 pm
- Monday, February 24, 2020 | 1:00 - 4:00 pm
- Monday, March 30, 2020 | 1:00 - 4:00 pm
- Monday, April 27, 2020 | 1:00 - 4:00 pm
- Monday, May 18, 2020 | 1:00 - 4:00 pm
- Monday, June 29, 2020 | 1:00 - 4:00 pm