HSA-SCRI Webinar: ICH E6 (R3) Guideline for GCP - Annex 2
Public webinar recording on overview to ICH E6 (R3) Annex 2
This webinar was organised by the Health Sciences Authority (HSA) and the Singapore Clinical Research Institute (SCRI) on 14 August 2026 and provided an overview of Annex 2 of the ICH E6 Guideline on Good Clinical Practice (GCP).
Clinical trials increasingly incorporate decentralised elements, pragmatic designs and/or real-world data to improve accessibility, efficiency, and relevance to everyday clinical practice. Annex 2 addresses additional GCP considerations for interventional clinical trials that incorporate one or more of the following:
Decentralised elements, which involve trial activities conducted outside the investigator’s location, such as electronic consent, telemedicine, home visits, home delivery of trial medications, digital health technologies, and electronic clinical outcome assessments.
Pragmatic elements, which involve the integration of usual clinical practice into trial design and conduct.
Real-World Data, which refers to data from sources outside of clinical trials, such as Electronic Health Records, registries, and claims databases.
Click here to download the slide deck [PDF, 2.9 MB] (opens in new tab)

