- Stage
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Scientific Integrity
- Topic
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Clinical Quality Management Program (CQMP)
Need assistance with the Clinical Quality Management Program?
The conduct of rigorous, trustworthy clinical research requires a robust process to monitor research quality. The Clinical Quality Management Program (CQMP) provides a framework to oversee prospective, consenting clinical research studies that do not have external or internal monitoring procedures. The CQMP policy requires that relevant studies overseen within the DUHS IRB receive routine, standardized monitoring by trained quality management (QM) reviewers within their local clinical research unit. Each study that falls within the policy must have an individualized, approved CQMP plan that includes regulatory and participant chart reviews at standardized intervals. QM reviewers receive regular training in how to develop clinical quality management plans, conduct regulatory file and participant chart reviews, and enter quality review reports into a centralized database. CQMP plans and quality reviews focus on key quality indicators including essential regulatory binder documents, participant consent, eligibility, safety reporting, and study data integrity.
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 Plan Complexity Level
High
Studies using procedures or interventions that are generally considered to be moderate to high risk to the participant (or unknown risk) or pose significant regulatory risk to the investigator/institution (e.g., prospective Phase I–III drug/biologic studies, significant risk device studies, surgical procedures). This includes studies under an IND or full IDE (Significant Risk - SR) regulations with the FDA.
Medium
Studies that do not meet high complexity criteria and involve more than low risk to the participant, have a study design that increases overall complexity, or exhibit another characteristic that increases regulatory risk to the investigator/institution. This may include studies using FDA approved drugs/biologics for their labeled indication or investigational devices under abbreviated IDE (Nonsignificant Risk - NSR) regulations with the FDA.
Low
Studies that do not meet high or medium complexity criteria and use procedures generally considered to be minimal or low risk to the participant and investigator/institution (e.g., blood sample collection, imaging not using sedation, questionnaires, and behavioral surveys). This may include studies using medical devices that are minimal risk to the participant and low regulatory risk to the investigator/institution (e.g., FDA cleared/approved devices used for their labeled indication, general wellness products, mobile applications/software that are either unregulated or under enforcement discretion, or diagnostic devices exempt from IDE regulations).
Review frequency
| Complexity Level | Regulatory Reviews | Participant Chart Reviews - by Cumulative Enrollment | ||
|---|---|---|---|---|
| 1-39 | 40-99 | 100 and over | ||
| HIGH | Quarterly (every three months) | Quarterly 3 records | Quarterly 10% of records | Quarterly 10 records |
| MEDIUM | Bi-annually (every six months) | Quarterly 3 records | Quarterly 10% of records | Quarterly 10 records |
| LOW | Annually (once per year) | Biannually 3 records | Biannually 10% of records | Biannually 10 records |
| Regulatory file reviews and participant chart reviews must be completed at this frequency (at a minimum) based on the first participant enrollment date. Reviews may be conducted more frequently at the request of the PI, CRU/OO, or CQMP central office. The number of participant chart reviews required at each monitoring visit may be reduced in unique circumstances at the request of the CRU/OO and with the approval of the CQMP central office (e.g., excessive percentage of participants being monitored when using cumulative enrollment to calculate number of reviews in relation to study design and rate of incremental accrual). | ||||
Clinical Quality Management Plans and Review tools
CQM Plan creation tools
Regulatory file review tools
Participant chart review tools
Review closeout request forms
“Coming Soon - February 2025”
The CQMP Regulatory and Participant review tools have been revised and will be effective in early February 2025. To preview the revised tools, please click on the links below.
Revised Regulatory File Review Tool Instruction Sheet – Preview Only
Revised Participant Chart Review Tool Instruction Sheet – Preview Only
Training
Quality management reviewer training
The CQMP offers monthly training sessions for CRU staff who have been identified by their leadership as a candidate to fill the role of a QM reviewer. Candidates should be a Tier 3 or higher based on the Workforce Engagement and Resilience (WE-R) tier advancement process. Any deviation from this requirement must be reviewed and approved by the CQMP office. CQMP QM Reviewer training is comprised of two sessions; attendance at both sessions is mandatory in order to fulfill the training requirements. At each training session, we will review:
Session 1:
- CQMP Overview & Terminology
- CQMP Policy & Plan Creation
- QM Workflow, Tools, & Reports
- CQMP REDCap database demonstration
Session 2:
- Conduct a sample QM Review using the CQMP tools and mock study documents
CQMP QM Reviewer training is conducted virtually.
Session 1 is offered on the dates listed below from 1:00-4:00 pm (*unless otherwise indicated).
Session 2 is offered twice during the same week, on Thursday (1:00-2:30 pm) or Friday (9:30-11:00 am). To register for a training session, please email CQMP@duke.edu by the Thursday prior to the scheduled training you wish to attend.
If your office has an immediate need for QM Reviewer training and the designated QM reviewer(s) cannot attend a scheduled training listed below, please contact our office at CQMP@duke.edu.
2024
- Monday, November 25, 2024
- Monday, December 16, 2024
2025
- Monday, January 27, 2025
- Monday, February 24, 2025
- Monday, March 24, 2025
- Monday, April 28, 2025
- Monday, May 19, 2025
- Monday, June 23, 2025
- Monday, July 28, 2025
- Monday, August 25, 2025
- Monday, September 22, 2025
- Monday, October 27, 2025
- Monday, November 17, 2025
- Monday, December 15, 2025
2026
- Monday, January 26, 2026
Ongoing quality management reviewer education sessions
The CQMP offers Ongoing Education Sessions for CQMP QM Reviewers.
At this time, all sessions will remain virtual. The recorded session and slide deck are available in the CQMP Box folder following the presentation.
Sessions are offered the 2nd Thursday of alternating months at 2:00 pm (unless otherwise noted).
- January 9, 2025 – CQMP REDCap Revised Tools
- January 23, 2025 – CQMP REDCap Revised Tools (repeated)
- March 13, 2025
- May 8, 2025
- September 11, 2025
- November 13, 2025
Please contact us at CQMP@duke.edu for questions or with topic suggestions!