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 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.