Course Information

This is a professionally developed, interactive and engaging online course for anyone involved in running a clinical trial or working within a clinical trial environment.

This course will ensure participants comply with the latest regulations (31A-1-3) for Trial Master Files. (TMF)

Learning Objectives

• Review the GCP requirements for essential documents
• Describe the significance of document management in clinical research
• Learn how to set up, maintain and manage a document system that meets regulatory standards
• Understand the role of audit, knowing how to archive documentation and prepare for a quality assurance (QA) audit or regulatory inspection.