The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway. 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 draft ICH E6(R3) guideline from May 2023 with helpful summaries of the updates.

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