Decentralised Clinical Trials — Meeting ICH E6(R3) Expectations
Interpreting ICH E6(R3) for hybrid and fully decentralised trials: risk-based quality management, informed consent, and oversight of digital health technologies.
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Browse more webcastsICH E6(R3) is now in force, and the guidance is unusually explicit about decentralised elements — from eConsent to sensor-based endpoints. This session decodes what the guideline actually expects, where sponsors are getting it right, and where inspectors are pushing back.
Expect concrete examples from three ongoing decentralised trials, a walkthrough of the quality-by-design risk mapping we recommend, and clear guidance on vendor oversight for the digital health technologies now in your protocols.
Session agenda
A concise walkthrough of the sections most relevant to decentralised elements.
What worked, what did not, and what inspectors flagged in each case.
Focused Q&A on managing DHT vendors under the revised guideline.
What you'll take away
Your speakers
Good to know
Yes — many of the risk-based quality principles apply broadly under E6(R3), even without decentralised elements.
Yes, eConsent is covered in the case studies segment, including one where an eConsent gap triggered a GCP finding.
The core focus is ICH E6(R3), with call-outs where FDA and EMA interpretation diverges in practice.
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