Course Description

This course is designed to provide a basic understanding of the GCP audit process in clinical drug development and will 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. In addition, all steps involved in the audit process – planning, conduct, documentation, follow-up and close-out – will be explained.

The role of clinical research professionals involved in the audit process such as investigators, CRAs and data managers, will be addressed. General expectations and specific requirements from GCP auditors will be described. Finally, qualification requirements for auditors are included.

Learning Objectives

• Understanding the role of audits within quality assurance
• Differentiating the various types of audits
• Being familiar with applicable audit standards
• Knowing the data requirements specific to GCP audits
• Preparing for sites and system audits
• Evaluating and writing audit findings, audit reports and follow-up actions
• Recognising GCP audits as a method of ensuring data quality

Programme highlights*

• Quality and audit concepts 
• Current auditing standards 
• Different approaches to planning and conducting audits
• Different types of audits
• Reporting audit findings

Who should attend?

The course is designed for clinical research professionals with previous working experience in a GCP environment. Auditing experience is not required.

(*) Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or to cancel the event.

Trainer: Gentiane Verstraeten