As clinical trial designs continue to evolve, ICH E6(R3) Annex 2 provides essential considerations for trials that incorporate pragmatic and decentralised elements, make use of Real-World Data (RWD), or rely on Digital Health Technologies (DHTs).

A clear understanding of Annex 2 has become increasingly important for all stakeholders involved in clinical research – including regulators, ethics committees, industry, academia and service providers – to ensure proportionate, scientifically sound and operationally feasible approaches.

This course offers practical guidance on applying Annex 2 across the clinical trial lifecycle, including expectations for investigator and sponsor oversight, safety data collection in pragmatic, decentralised and technology-enabled settings, and the assessment of RWD fitness-for-purpose and access pathways.

Participants will gain a structured understanding of how Annex 2 supports evolving clinical trial designs and aligns with the overarching principles of ICH E6(R3).