Upcoming webcastRegulatory Compliance
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.
Host & moderator
Dr. Jonas Lindqvist
Global Head, Clinical Compliance · AstraZeneca
Date
Wed 19 Aug 2026
Time
15:00 UTC
Duration
60 min
Price
Free
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About this session
ICH 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
15:00 – 15:15
ICH E6(R3) — what actually changed
A concise walkthrough of the sections most relevant to decentralised elements.
15:15 – 15:40
Three DCT case studies
What worked, what did not, and what inspectors flagged in each case.
15:40 – 16:00
Q&A on vendor oversight
Focused Q&A on managing DHT vendors under the revised guideline.
What you'll take away
1
What ICH E6(R3) explicitly requires for decentralised and hybrid trials
2
A risk-based quality management workflow aligned with the guideline
3
Vendor oversight expectations for digital health technologies
4
Common inspection findings across DCT sponsors in 2025
Your speakers
Host
Dr. Jonas Lindqvist
Global Head, Clinical Compliance · AstraZeneca
Moderator
Dr. Anika Desai
Head of Quality Assurance · Novartis
Good to know
Is this session relevant if I run fully site-based trials?+
Yes — many of the risk-based quality principles apply broadly under E6(R3), even without decentralised elements.
Will you cover eConsent specifically?+
Yes, eConsent is covered in the case studies segment, including one where an eConsent gap triggered a GCP finding.
Do you touch on FDA vs EMA expectations?+
The core focus is ICH E6(R3), with call-outs where FDA and EMA interpretation diverges in practice.
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