The CDISC Protocol Representation Model (PRM) Version 1.0 is released and available at http://www.cdisc.org/protocol.
The Model contains study protocol concepts such as Trial Design, Eligibility Criteria, and addresses the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries. Additional protocol domain areas, activities, definitions, and associations are included along with the roles that participate in the respective activities.
The Model leverages the BRIDG Release 3.0 Protocol Representation sub-domain. It includes all classes in the BRIDG Protocol Representation sub-domain as well as classes from related BRIDG sub-domains; for example, those required for ClinicalTrials.gov and the WHO registries.
The standard is available as a PRM V1.0 Package which includes all materials collected and published as a formal release of the PRM. These items are gathered in a single package (ZIP file) and is available for download.
Launched in 2002 as a joint HL7 and CDISC project, the Protocol Representation project has seen years of efforts by a large group of experts, and the release of the Model marks a major accomplishment for all those who were involved. Work will continue as future versions evolve, and the team asks for comments and questions to be submitted via the CDISC Forum under the Protocol Representation Model V1.0 topic.
We’d like to thank everyone who contributed both directly and indirectly for their dedication and persistence, and the hours upon hours of time volunteered. Although the team membership has changed over the years since the groups inception in 2002, we would like to recognize the efforts of all those who have contributed along the journey. Unwavering dedication and the ability to embrace continuous change and moving targets while working toward this milestone warrants a well-deserved, “congratulations”!
Future project activities include a User’s Guide which will contain implementation examples. The team welcomes new members and if you would like to join please contact Dave Gemzik or Lisa Chatterjee, as much more work lies ahead!