Introduction to GCP Auditing in Clinical Trials

This one day course is designed to provide a basic understanding of the Good Clinical Practice (GCP) audit process in clinical drug development and to demonstrate the importance of audits in ensuring good data quality.
An overview of quality management, quality assurance and quality control in clinical research will be presented. The role of audits in this context will be highlighted, as well as the application of current auditing standards, such as ENGAGE and ISO 19011.
The definition and differentiation of study audits and system audits will be clarified. All steps involved in the audit process - planning, conduct, documentation, follow-up and close-out - will be explained. The course addresses the role of clinical research professionals involved in the audit process such as investigators, Clinical Research Associates (CRAs) and data managers. General expectations and specific requirements from GCP auditors as well as qualification requirements for auditors are included.

This course is designed for clinical research professionals with previous working experience in a GCP environment. People interested in the ins and outs of Audits. Auditing experience is not required.