Comparison Tool: ICH E6(R3) FINAL to ICH E6(R2)

ICH E6R3 to R2 Comparison Tool_Thumbnail.jpg
ICH E6R3 to R2 Comparison Tool_Thumbnail.jpg

Comparison Tool: ICH E6(R3) FINAL to ICH E6(R2)

$199.00

To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.

Course outline HERE

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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a guideline for ICH E6(R3) Good Clinical Practice, which reached step 4 on January 06, 2025. This final guideline includes the GCP Principles and Annex 1. Updates to Annex 2 reached step 2 on November 06, 2024. Annex 2 focuses on additional GCP considerations, with examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). One main objective in revising the GCP guideline was to interweave themes from ICH E8(R1) General Considerations for Clinical Studies guideline throughout, including Quality by Design (QbD) - building quality into the study design, identifying factors that are Critical to Quality (CtQ), engaging stakeholders early and throughout the clinical trial process, using a proportionate risk based approach to quality management, and cultivating a culture of quality. The GCP draft guideline modernized, expanded, and reorganized the ICH E6(R2) 2016 addendum. The updates are extensive and impactful across stakeholders and roles.

This tool is a line by line comparion between the ICH E6(R2) guideline from 2016 and the ICH E6(R3) guideline from January 2025 with helpful summaries of the updates. Draft Annex 2 is also included.

Includes:

  • Unlimited access to one Excel format comparison tool

Audience

All clinical research personnel

 
 

ONBOARDING OR ANNUAL REVIEW CURRICULUM

This course can be used alone or as part of the full curriculum, including:

  1. GCP Training: ICH E6(R2) - Available HERE

  2. Good Documentation Practices and ALCOA-C - Available HERE

  3. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE

  4. Structure and Content of Clinical Study Reports (ICH E3) - Available HERE

  5. Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE

  6. Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE

  7. Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE