The clinical research landscape is changing once again with the introduction of ICH GCP Annex 2 a long-awaited extension expected to be finalised soon. As with ICH E6 (R3) and Annex 1, this new guidance brings important updates that will directly impact how clinical trials are designed, managed, overseen, and documented.
At TrainingOnline4U, we’ve been working hard to ensure you’re fully prepared. Our team has been developing a highly interactive and engaging online Annex 2 course to sit alongside our existing GCP E6 (R3) and Annex 1 training. Once Annex 2 is officially released, we will finalise and launch the course so your teams can stay compliant with confidence.
Why Is Annex 2 Training Needed?
Annex 2 introduces specific expectations beyond core GCP: Annex 2 introduces substantial topic-specific principles that go beyond the foundations set in ICH E6 (R3). Training ensures teams understand the added safeguards, documentation expectations, and operational controls now required.
It strengthens the focus on risk-proportionate approaches: Annex 2 encourages adapting GCP processes to the investigational product, technology, and trial complexity.
New expectations for decentralised and digitally supported trials: Annex 2 includes requirements for remote assessments, digital endpoints, electronic device data, technology validation, and participant safety in decentralised environments.
Better integration of manufacturing and chain-of-custody requirements: This is particularly relevant for advanced and innovative therapies with unique storage, delivery, and traceability needs.
A greater emphasis on roles, accountability, and documentation: Clearer expectations around delegation, vendor oversight, and traceability strengthen compliance.
Regulatory expectations are changing: Training demonstrates readiness and proactive adoption of evolving global standards.
Our Annex 2 Course – Coming Soon
We have been developing a brand-new interactive online course including:
- Scenario-based learning
- Animated explainers
- Short comprehension checks
- Knowledge assessments
- Downloadable summaries
This course will supplement our existing ICH GCP E6 (R3) and Annex 1 modules and a discount code will be provided to all of our existing customers that have taken GCP E6 (R3) to ensure they remain compliant.
We await final publication of Annex 2 before updating the course with confirmed wording. Once released, the course will go live.
Be the First to Know
If you would like early access or want your team to be notified when the course becomes available, please complete the form provided.
