ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure
ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure
The complete guide to ICH E guidelines, focusing on the new ICH E6(R3), the global standard for Good Clinical Practice.
It is the operational tool for Sponsors, CROs, Clinical Operations, QA/GCP and PV.
Inside you will find:
📘 Principles and structure of E6(R3) and differences from R2.
🏥 Sponsor & CRO Responsibilities , investigator responsibilities and site management.
🧭 Risk-Based Approach in Clinical Trials , RBQM and quality by design.
📁 Trial Master File , essential documents, data integrity & EDC.
⚠️ Complete checklists for sponsors, CROs, sites, TMFs, and pharmacovigilance.
🧩 Integration with ICH E2 guidelines (E2A, E2B(R3), E2D, E2E).
Perfect for internal training, EMA/FDA/MHRA inspections and GCP audits.
Format: Professional PDF
Pages: 79
Updated: December 2025
Languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.