ICH E6(R3): An Introduction

Provides learners with an examination of developments in ICH Good Clinical Practice.

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About this Course

The course describes the ICH’s Guideline for Good Clinical Practice E6(R3). E6(R3) includes several updates from E6(R2). This video-based course examines how the changes affect the responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs). It details changes to the principles of GCP and key terminology used in Annex 1. The course concludes with an exploration of Annex 2 and its application to emerging technologies and clinical trial designs.

Course Preview:

Language Availability: English

Suggested Audiences: Academic Medical Centers, Biomedical Product Companies, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators, Regulatory Agencies, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations (Note: This is a standalone course and is not included as part of a subscription to the Good Clinical Practice Series)
Independent Learner Price: $129 per person

Demo Instructions

Course Content

Principles and Concepts

The module provides an overview of the notable changes introduced in the E6(R3) guideline, including the emphasis on quality and risk management. It details the alterations of the principles of GCP and explains the key terms used in the new guideline.

Recommended Use: Required
ID (Language): 21806 (English)
Author(s): Chinonso Singleton, MSc - LIBRE, LLC

Investigator Updates

The module describes the new responsibilities for investigators under E6(R3). It details changes in the practices and requirements for informed consent while discussing the new guidelines for investigational product management.

Recommended Use: Required
ID (Language): 21807 (English)
Author(s): Cindy Gates, JD, RN, CIP - Independent Consultant

Sponsor Updates

The module details the primary changes introduced by the sponsor section in E6(R3). It describes the sponsor’s key responsibilities in the design, conduct, and management of clinical trials. The module also explains how E6(R3) concepts apply to the sponsor.

Recommended Use: Required
ID (Language): 21808 (English)
Author(s): Chinonso Singleton, MSc - LIBRE, LLC

Additional Changes

The module discusses the new responsibilities and requirements for Institutional Review Boards (IRBs). It details the requirements for Investigator's Brochures (IBs) and describes the new guidelines for data governance. The module also explains the revisions to the requirements for essential records.

Recommended Use: Required
ID (Language): 21809 (English)
Author(s): Cindy Gates, JD, RN, CIP - Independent Consultant

Annex 2 Overview

The module describes the principles and guidelines outlined in E6(R3) Annex 2 and their relationship to Annex 1. It also explains how Annex 2 applies to emerging clinical trial designs and varying data sources.

Recommended Use: Required
ID (Language): 21810 (English)
Author(s): Chinonso Singleton, MSc - LIBRE, LLC

FAQs

Who should take ICH E6(R3): An Introduction?

Learners who wish to gain a foundational knowledge of the requirements and responsibilities outlined in ICH E6(R3).

The course is ideal for academic medical centers, commercial biopharmaceutical research centers, and independent clinical research facilities looking to supplement their current GCP training with an up-to-date overview of ICH E6(R3).

How does ICH E6(R3): An Introduction complement other CITI Program courses?

ICH E6(R3): An Introduction imparts skills and knowledge that are a perfect complement to CITI Program’s GCP for Clinical Investigations of Drugs and Biologics (ICH) and GCP ICH Refresher as it provides foundational knowledge of the principles and practices for adhering to the latest revision of ICH’s E6 guideline.

How long will the course take a learner to complete?

The modules vary in length, from 9 to 19 minutes. The total time of the combined modules is 1 hour and 15 minutes.

Is the course eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.

Is there a course that learners must take prior to ICH E6(R3): An Introduction

There are no prerequisites for ICH E6(R3): An Introduction.

Does ICH E6(R3): An Introduction meet the minimum criteria established by TransCelerate Biopharma for mutual recognition of ICH E6 GCP Training?

No. ICH E6(R3): An Introduction is not recognized by TransCelerate Biopharma as meeting the minimum criteria for mutual recognition of ICH E6 GCP Training. It is intended for learners already familiar with the ICH E6(R2) guideline. The course comprises a necessary supplement to existing GCP training rather than a substitute for basic ICH E6 GCP knowledge.

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