This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credit for attending.

Title: The crucial role of The Clinical Quality Management Plan (CQMP) in establishing site-based protocol integrity

Presenter: Dr Alan Touch

Summary:

The Clinical Quality Management Plan (CQMP) for clinical trials is a structured approach to ensuring the integrity, reliability, and compliance of clinical research at the site level. It is core to maintaining Good Clinical Practice (GCP)standards and regulatory requirements throughout the trial process.

CQMP establishes the quality management guidelines for tasks related to the Sponsor, CRO and Study Site for responsibilities for a defined Clinical Trial Protocol. This plan is normally the responsibility of the Sponsor Quality Assurance department although its development and implementation can be facilitated by a Quality and GCP Audit Partner.

This presentation will delineate the critical role of CGMP in GCP, a delineation of the actual types of content for a CGMP, the steps to the development of the CQMP and the effect the 21st Century Cures Act on these responsibilities and current US FDA expectations regarding site responsibility for clinical trial protocol data integrity.

Who Should Attend:

• Quality and Clinical Development personnel
• Regulatory personnel
• Clinical trial project managers
• Site study personnel
• Site Management Organization administrators

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