[3-B-2-02] Utilizing the Digital Protocol (UDP)
This talk will describe an umbrella project that brings together work from multiple bodies and seeks to develop guidance on how this may be implemented using HL7 FHIR®.
A clinical research study is governed in all its aspects by the protocol agreed with the relevant regulator.
The International Council of Harmonization (ICH) is a Unique Initiative for Regulators and Industry to collaborate on various topics. Its membership spans across the globe from global regulatory agencies to Pharma and Trade Organizations. M11 and M2 are two working groups within ICH that focus on the Clinical Electronic Harmonization of the Protocol (CeSHarP) and Digitalization of the protocol.
CDISC and TransCelerate BioPharma have been working on the Unified Study Design Model (USDM) which is closely aligned to CeSHarP but provides a more granular set of data points.
UDP is an HL7 Vulcan Accelerator project that brings together all this work and asks how the work can be implemented using HL7 FHIR® for the better definition and execution of a protocol.
The presentation will describe work done so far and outline future plans.
Bringing together models and approaches from different organizations provides coordination challenges and the talk will present a framework within which all the components lie.
A clinical research study is governed in all its aspects by the protocol agreed with the relevant regulator.
The International Council of Harmonization (ICH) is a Unique Initiative for Regulators and Industry to collaborate on various topics. Its membership spans across the globe from global regulatory agencies to Pharma and Trade Organizations. M11 and M2 are two working groups within ICH that focus on the Clinical Electronic Harmonization of the Protocol (CeSHarP) and Digitalization of the protocol.
CDISC and TransCelerate BioPharma have been working on the Unified Study Design Model (USDM) which is closely aligned to CeSHarP but provides a more granular set of data points.
UDP is an HL7 Vulcan Accelerator project that brings together all this work and asks how the work can be implemented using HL7 FHIR® for the better definition and execution of a protocol.
The presentation will describe work done so far and outline future plans.
Bringing together models and approaches from different organizations provides coordination challenges and the talk will present a framework within which all the components lie.