Module 5 Presentations

05/07/2024

ICH GCP Guideline E6 (2)

The document is divided in eight chapters which explain and describe • 13 “golden” rules of GCP • The roles and obligations of main persons and bodies involved in clinical research (e.g. sponsor, clinical investigator, ethics committees, CRO) and Data monitoring committees in clinical trials with respect to GCP • Requirements on clinical trial management • Scope of essential clinical trial documentation • Requirements on data handling and recording, monitoring, management and reporting.

The Organisation for Professionals in Regulatory Affairs

51

Main GCP Chapters

1. Glossary 2. The Principles of ICH GCP 3. The Institutional Review Board / Independent Ethics Committee (IRB/IEC) 4. Investigator 5. Sponsor 6. Clinical Trial Protocol and Protocol Amendment(s) 7. Investigator’s Brochure 8. Essential Documents for the Conduct of a Clinical Trial

The Organisation for Professionals in Regulatory Affairs

52

26