For decades, the clinical trial protocol (in PDF) has been the most important artifact in our industry and yet it remains a static, narrative document that every downstream system must manually interpret and rebuild.
This session will introduce the concept of the eProtocol (digital protocol): a structured, machine readable representation of protocol usable for trial setup and execution across systems such as RTSM, EDC, eCOA, and CTMS.
We will explore:
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What an eProtocol is (and what it is not)
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How industry standards (ICH M11, TransCelerate, CDISC, HL7 FHIR) are converging
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Why RTSM could be of the biggest beneficiaries
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How eProtocols could reduce build time, amendments, and operational risk
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What this means for the future operating model in Clinical Operations
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Discuss around members of activity in this area
The session will include a short presentation followed by an open discussion with RPS members on real-world challenges, opportunities, and readiness.
The invite will be sent out a week before the event.
This is a members only presentation and discussion.
