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
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.