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GUIDANCE V02, October 2025

Recommendation Paper on Decentralised Elements in Clinical Trials

EMA · 2025 European Medicines Agency
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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METADATA
TypeGUIDANCE
Year2025
VersionV02, October 2025
StatusCurrent
FormatPDF
Pages—
Size—
Last reviewedOCT 2025
SOURCE
PDF · CANONICAL LINK https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf ↗
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