What’s New in GCP: ICH E6(R3) Annex 2 Explained

Reasons to attend

ICH E6(R3) Annex 2 was adopted on 3 June 2026, introducing dedicated GCP guidance for trials that incorporate decentralised elements, pragmatic designs, and real-world data. Do you know what it means for your day-to-day work?

In just 90 minutes — or 30 minutes via self-paced eLearning — get a clear, practical first look at what is new and what you need to do differently.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

We provide this course in two distinct formats: Webinar (90 minutes) OR eLearning (~30 minutes)

Course Description

The clinical trial landscape is evolving rapidly. Decentralised trials, digital health technologies, and real-world data are no longer the exception — they are becoming part of everyday clinical research practice. ICH E6(R3) Annex 2, adopted on 3 June 2026, provides the GCP framework that governs these modern approaches.

In this 90-minute webinar — also available as a 30-minute self-paced eLearning module — you will get a structured, expert-led introduction to what Annex 2 says, why it matters, and what it means for your role in clinical research.

You will explore the three core methodologies addressed in Annex 2: decentralised elements (remote visits, home nursing, and digital health technologies), pragmatic elements (integrating usual clinical practice into trial design), and real-world data from sources such as electronic health records, registries, and claims databases. You will also examine how the updated guidance shapes key responsibilities for investigators and sponsors — from informed consent and investigational product management to safety reporting and oversight.

Whether you are a CRA managing a site, a sponsor overseeing a complex trial, or a professional keeping your GCP knowledge current, this course gives you the clarity and confidence to work with ICH E6(R3) Annex 2 from day one.