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Clinical Quality Management Program (CQMP)

Need assistance with the Clinical Quality Management Program?

The Research Quality Programs were developed to provide standardization, monitoring, and a means to implement best practices across research at Duke.

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.

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 LevelRegulatory ReviewsParticipant Chart Reviews - by Cumulative Enrollment
  1-3940-99100 and over
HIGHQuarterly (every three months)Quarterly
3 records
Quarterly
10% of records
Quarterly
10 records
MEDIUMBi-annually (every six months)Quarterly
3 records
Quarterly
10% of records
Quarterly
10 records
LOWAnnually (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

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 CQMP@duke.edu mailbox to request help for your research team.

Review closeout request forms

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
     

At this time, all training sessions will remain virtual. Session 1 is offered on the dates listed below from 1:00-3:30 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.

  • Monday, January 22, 2024
  • Monday, February 26, 2024
  • Monday, March 25, 2024 
  • Monday, April 22, 2024
  • Monday, May 20, 2024
  • Monday, June 24, 2024
  • Monday, July 22, 2024
  • Monday, August 26, 2024
  • Monday, September 23, 2024
  • Monday, October 28, 2024
  • Monday, November 25, 2024
  • Monday, December 16, 2024
  • Monday, January 20, 2025
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).

  • Thursday, January 11, 2024
  • Thursday, March 14, 2024
  • Thursday, May 9, 2024: CANCELED; reschedule date TBD
  • Thursday, September 12, 2024
  • Thursday, November 14, 2024

Please contact us at CQMP@duke.edu for questions or with topic suggestions!