ACRP Certified Professional ACRP-CP Question # 28 Topic 3 Discussion

A Corrective and Preventive Action (CAPA) plan is implemented to address deviations and prevent them from recurring. In this context, the purpose of the CAPA is to establish a procedure for the Principal Investigator (PI) to ensure proper oversight of protocol deviations. This ensures that all future deviations are appropriately managed, reviewed, and documented according to GCP standards.

The answer is verified from GCP guidelines which emphasize that CAPA should focus on identifying root causes and establishing processes to prevent future deviations.

"A CAPA plan must address the root cause and implement systematic actions to prevent the recurrence of protocol deviations."

Objectives:

Ensuring PI oversight in protocol adherence

Maintaining data integrity through systematic corrective actions