Module 1: ICH E6(R2)

Target Audience

This course is particularly directed at government regulatory reviewers and inspectors. It is also applicable for other stakeholders, including investigators, study teams, ethics committee members, research organizations, and sponsors.

Learning Objectives

The primary learning objective of this activity is to learn key concepts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) Guideline.

Upon completion of this activity, learners will also be able to:

  • Understand the mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the relevant research guidance documents it has produced.
  • Describe the background and purpose of Good Clinical Practice Guidelines [ICH E6(R1)] and the subsequent revisions for ICH E6(R2).
  • Introduce the overarching goals and different parts of ICH E6(R2) and the areas of change.
  • Identify to whom ICH E6(R2) applies.
  • Demonstrate the applicability of the ICH E6(R2) Good Clinical Practice principles to regulatory reviewers and inspectors.

Additional Information

Provided by: 

Multi-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard, & Partners HealthCare System

Course summary
Available credit: 
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation
Course opens: 
07/08/2019
Course expires: 
08/07/2020
Cost:
$0.00

[Faculty Information: credentials, associated hospitals, bio information]

[Accreditation Statement]

Available Credit

  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation

Accreditation Period

Course opens: 
07/08/2019
Course expires: 
08/07/2020

Price

Cost:
$0.00
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