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Conducting Clinical Trials With Decentralized Elements. Guidance for Industry, Investigators, and Other Interested Parties

FDA GUIDANCE SNAPSHOT:
Conducting Clinical Trials With Decentralized Elements. Guidance for Industry, Investigators, and Other Interested Parties

This guidance provides FDA’s recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.

OCTOBER 2026

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Recentes

  • EMA’s ePI Roadmap
  • Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
  • The new CTIS Sponsor Handbook (v6.2, March 2026)
  • New revision of the Q&A document on art. 10(a) interruption of supply published
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • New Harmonised Standards under MDR – April 2026
  • EMA/CHMP: Updated Guideline on Active Substances published
  • Data Quality Framework for EU medicines regulation: application to Real-World Data

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