Digital Protocols and RTSM

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:

• What an eProtocol is (and what it is not)

• How industry standards (ICH M11, TransCelerate, CDISC, HL7 FHIR) are converging

• Why RTSM could be of the biggest beneficiaries

• How eProtocols could reduce build time, amendments, and operational risk

• What this means for the future operating model in Clinical Operations

• 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.