GUIDANCE V02, October 2025
Recommendation Paper on Decentralised Elements in Clinical Trials
ABSTRACT — EDITORS' SUMMARY
EMA position on DCT components — direct-to-participant shipping, remote source data verification, electronic informed consent. Joint with the Clinical Trials Coordination Group.
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PDF · CANONICAL LINK https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf ↗ RELATED · SAME AUTHORITY