The ICH Expert Working Group (EWG) has released additional training materials to support the implementation of ICH E6(R3), with a specific focus on Module 4: Informed Consent.
Two transcripts are now available:
🔹 Module 4.1 (5 pages)
Addresses key questions such as:
Who is involved in the informed consent process?
What are the essential elements to be included in informed consent materials and discussions?
🔹 Module 4.2 (6 pages)
Provides further clarification on:
The training materials are available via the ICH Training Library:
👉 https://lnkd.in/esvUcCiZ