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

- Clinical Research Associates (CRAs), monitors, and clinical trial managers
- Sponsor and CRO study managers and project managers
- Investigators, site coordinators, and site staff
- Regulatory affairs and quality assurance professionals
- Data managers and clinical data specialists
- Anyone responsible for, or involved in, trials using decentralised elements, pragmatic designs, or real-world data

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.