Good Clinical Practice for Clinical Research Professionals

Complete, Certified ICH GCP E6 (R2+R3) Course for Investigators, Study Coordinators, Sponsors, Monitors and Study staff

Created by: Dr. Vincent Baeyens
Expert in Clinical Research and Good Clinical Practice

What Will I Learn?

• Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
• Learn the core principles of ICH-GCP R2 and R3 and how to implement them in practice
• Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
• Understand the purpose of the essential documents and the best practice for filing in the TMF
• Understand the essential requirements and contents of the Investigator's Brochure and the Protocol
• Practice on real cases: Identify common ICH-GCP inspection findings (FDA warning letters) and how to avoid them
• Practice on real cases: Conduct a gap analysis in your organization based on a real MHRA inspection report

Requirements

• No prior working experience or knowledge in clinical research is required to attend this course
• This course is dedicated to beginners as wells as to more advanced professionals willing to refresh their knowledge

Target audience

• This course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ICH-GCP