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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

High

Study Type Examples: Prospective Phase I–III interventional procedure, device, and/or drug studies (novel product or indication). All studies under an IND or IDE with the FDA.

Medium

Study Type Examples: Studies using FDA-approved drugs, devices, or biologics for their approved indication. Other studies that do not meet high complexity but are more than minimal risk (e.g., behavioral intervention, complex observational, tissue collection).

Low

Study Type Examples: Studies using procedures generally considered to be minimal or low-risk (e.g., blood sample collection, imaging not using sedation, questionnaires, and behavioral surveys).

Review Frequency