ICH E6(R3) Annex 2 (Use of Decentralised Elements in Clinical Trials) is the new section establishing principles for decentralised clinical trial (DCT) elements - reflecting COVID-19 acceleration + technology enablement + patient-centric trial design. Decentralised elements: remote participant identification + recruitment + screening; eConsent + remote consent + multimedia + comprehension verification; remote/home-based study procedures + nurse visits; direct-to-patient supply (investigational product shipment to home); remote monitoring + visit substitution + ePRO + telemedicine; wearable devices + sensors + continuous data collection; eSource + EHR integration + real-world data; remote source document verification + investigator oversight + risk-based approach. R3 emphasises: investigator oversight + accountability remains + protocol design considers DCT element risks + benefits + scientific validity + participant safety; regulatory pre-discussion advisable; vendor management for DCT-enabling technology + qualification + data integrity. eConsent: validated platform + electronic signature + identity verification + 21 CFR Part 11 + EU CTR; remote consent considerations (privacy + connectivity + family member presence); withdrawal mechanism. Remote monitoring: central + risk-based + statistical + on-site as triggered; sponsor + CRO oversight; investigator visibility. Wearables: vendor qualification + data integrity + ALCOA+ alignment + FDA Software as Medical Device (SaMD) + EMA + algorithm validation + clinical evidence. Real-World Evidence (RWE): EHR data + claims + registries + patient-generated; FDA + EMA RWE guidance + use for hybrid + synthetic control arms; ICH E20 (Adaptive Designs) integration. Coordinates with FDA Decentralised Clinical Trial Guidance + EMA Decentralised Clinical Trials Q&A + Health Canada + PMDA + 21 CFR Part 11 + ALCOA+ + WHO. ICH E6 + Annex 2 + DCT + eConsent + Wearables + RWE applies.
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