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.