UDP: Utilizing the Digital Protocol
UDP is a collaborative effort between Vulcan, CDISC and TransCelerate. The Guideline, Template and Technical Specification produced by ICH M11 provide a basis for development of an Information Model and Terminology and a FHIR Implementation Guide
The protocol is what drives every detail of a clinical trial.
Currently it is managed as PDFs and Word Documents.
Having a machine processable form of the protocol has huge implications across the board.