Learning Paths
Core
Build
- ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2
 - ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2
 - ICH E6 – Sponsor (Chapter 5) (R2)
 - ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2)
 - ICH E6 – Essential Documents (Chapter 8)(R2)
 - ICH E8 Objectives, Fundamentals, and General Principles
 - ICH E8 Section 3 – Designing Quality into Clinical Studies
 - ICH E8 Section 4 – Drug Development Planning
 - Serious Breaches
 
Refresh
Good Clinical Practices (cGCP)
ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2
 
							30 mins
						
																 
							Basic
						
									Good Clinical Practices (cGCP)
ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2
 
							30 mins
						
																 
							Basic
						
									Good Clinical Practices (cGCP)
ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2)
 
							15 mins
						
																 
							Basic
						
									Good Clinical Practices (cGCP)
ICH E8 Objectives, Fundamentals, and General Principles
 
							15 mins
						
																 
							Basic
						
									Good Clinical Practices (cGCP)
ICH E8 Section 3 – Designing Quality into Clinical Studies
 
							15 mins
						
																 
							Basic