Through lessons on audit planning, execution, and reporting, participants learn to identify and address deficiencies using corrective and preventive action (CAPA) plans and follow-up procedures. The module also examines common audit findings related to protocol noncompliance, inadequate documentation, investigational product management, and informed consent issues. Case examples help differentiate between routine and for-cause audits while emphasizing the importance of maintaining subject protection and data integrity throughout the audit process.
This module is intended for all research personnel, and particularly useful for clinical research coordinator professional development.
