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In January, 2010, the CDISC Protocol Representation Group published the final Protocol Representation Model Version 1.0.  The PRM has been described in detail in a number or articles, blogs and in its own documentation.  The intent of this article is to provide simple, basic answers to questions that have arisen recently about the PRM. 

What is the PRM V1.0?

The Protocol Representation Model Version 1 is a set of descriptive information about protocol concepts and how these concepts fit together.   This set of descriptive information is called a Domain Analysis Model (DAM), which is a structured framework for capturing data and process requirements for a topic. The protocol topic areas in PRM V1.0 are study design, eligibility criteria and study registries. 

Why is the PRM a DAM rather than a spreadsheet or dataset description?

The Protocol Representation Group (PRG), the team that developed the PRM, found that a DAM provided the ability to capture more information about the protocol concepts than a spreadsheet or dataset description.  This approach also allows for multiple implementations of this model using various technologies, e.g. an HL7 Version 3 message for Clinical Trial Registration, a CDISC ODM extension for Study Design, or a set of SDTM domains for Study Design.

Has the PRM been vetted?  If so, how?

The PRM V1.0 underwent the open, public CDISC review and comment process in 2009 in which about 250 comments were collected.  The PRG discussed each comment and determined how it should be handled:  Should the PRM be changed?  Should the comment be considered in a future version of the PRM?  Was the comment within the scope of the PRM?  Then the model was updated based on these decisions.  For results of this comment and review process, please see the spreadsheet posted here.

In addition to the CDISC PRM V1.0 review and comment process, the protocol concepts were also part of the CDISC public review of BRIDG Release 3.0 at the end of 2009.  The PRM V1.0 is a subset of BRIDG R3.0 concepts.  Additional comments were addressed during this review and the results are posted on the BRIDG page.

How is PRM V1.0 different from the BRIDG R3.0 Protocol Representation Sub-domain?

The PRM V1.0 is a subset (or "view") of BRIDG R3.0.  The Protocol Representation Sub-domain of BRIDG R3.0 is also a subset (or "view") of the larger BRIDG model.  Both of these subsets are similar, but the PRM V1.0 contains additional BRIDG concepts such as study registry information.  CDISC's scope for PRM V1.0 is slightly different from BRIDG's scope for the Protocol Representation Sub-domain.

Where can I find out more about the PRM V1.0?

The PRM V1.0 is available on the CDISC website.  More details about the model and its history are included in the document posted at this location.