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Scientific Integrity
Topic

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. 

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

The frequency for ongoing QM reviews must be included in the Plan and is dependent on the study’s complexity level, as follows:

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; however, they 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

Review Closeout and Adjusted Visits

The QM Reviewer, in consultation with the study team and CRU, should determine when to close out reviews and is responsible for notifying and providing the CQMP central office with applicable information at that time. Review Closeout Request forms should be submitted via the CQMP REDCap Database for CQMP approval.

Low complexity studies are eligible for Adjusted Participant Chart Reviews following 3 Participant Chart visits, even if accrual is open. At a minimum, the consent process should be reviewed; other sections may be reviewed as needed. Closeout forms should NOT be submitted for adjusted visits.
Review Closeout Requirements

A study must be closed to accrual with all participants off-study or reach one of the following milestones, at a minimum, before reviews are closed:

Complexity LevelRegulatory Closeout RequirementsParticipant Closeout Requirements
Low
  • Closed to accrual with pts still on-study; OR
  • After 2 regulatory visits, following the date of open to accrual, even if accrual is open
  • Closed to accrual with participants still on-study
Medium
  • Closed to accrual AND all pts off-study; OR
  • After 3 regulatory visits, following the date of open to accrual, even if accrual is open
  • Closed to accrual with participants still on-study as long as the intervention phase of the study is complete (e.g., all participants have completed treatment)
High
  • Closed to accrual AND all pts off-study AND the study is either closed with the IRB or only open for analysis purposes
  • Closed to accrual AND all participants off-study*

*unless the only reason participants are "on-study" is passive evaluation of medical records for clinical outcomes/endpoints, e.g., mortality, disease progression that doesn't involve adjudication, re-hospitalization, MI, etc., i.e., all direct interactions with participants for study purposes should be complete.

Review Closeout Request Forms

These tools are available in a Word document for convenience; however, they must be completed in the Clinical Quality Management (CQM) Database in REDCap as part of the closeout process.

Tip Sheet: Timing of CQMP Review Closeout

Tip Sheet: Timing of CQMP Review Closeout

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.

  • January 26, 2026
  • February 23, 2026
  • March 23, 2026
  • April 27, 2026
  • May 18, 2026
  • June 22, 2026
  • July 27, 2026
  • August 24, 2026
  • September 28, 2026
  • October 26, 2026
  • November 16, 2026
  • December 14, 2026
  • January 25, 2027
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
  • July 10, 2025
  • September 11, 2025
  • November 13, 2025

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

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.
Resources

RCA and CAPA Plan General Guidance

RCA and CAPA Plan Documentation