ICH E6(R3) Annex 2 for Site Staff

Remote Consent, Home Visits, Study Drug at Home and Real-World Data

A short, free course for research site staff on ICH E6(R3) Annex 2, adopted by ICH on 3 June 2026 and in effect in the EU from 15 January 2027. Three modules in plain language: what Annex 2 covers and remote consent and remote visits; home nursing, local healthcare providers and study drug shipped to participants; and pragmatic elements and real-world data such as EHRs and registries. Every lesson cites the Annex 2 section it rests on. Expert review pending: this course has not yet been reviewed by a subject matter expert. Check what your regulator and sponsor require for each study.

6 lessons, about 28 minutes. Free, in your language.

Annex 2 and Decentralized Elements

Home Visits, Local Providers and Study Drug at Home

Pragmatic Elements and Real-World Data