ASQ Raleigh had its second Life Sciences Special Interest Group (SIG) meeting of the year on May 20 at the NC Biotech Center. Dr. Alan Touch gave a presentation titled “THE CLINICAL QUALITY MANAGEMENT PLAN — GCP Clinical Trial Site Compliance Mandatory to Study Data Integrity.”
Fifteen people, including non-members, attended the meeting and participated in networking and discussion. During the introduction, Dr. Touch emphasized how much clinical studies and patients count on the Quality professionals to ensure safety and integrity.
Dr. Touch first covered the key concepts, including
- The GCP framework and ICH E6 R3
- What’s the Clinical Quality Management Plan (CQMP)
- Key components of CQMP
- Site considerations
- Typical content of a CQMP template
To help illustrate the critical role of a CQMP, Dr. Touch shared a case study in which highly respected medical sites failed in several aspects in the GCP audit when no CQMP was in place. The example led to a number of questions and comments from the audience, for example
- the roles and responsibilities of the sponsors, Contract Research Organizations (CROs), and medical sites in developing and implementing the CQMP
- the role of the Quality functions
- how to evaluate and select sites
If you are interested in clinical quality management or related topics, please let us know.
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
Register here.
