Skip navigation

Protocol

CDISC Protocol Representation Model

Standards in Production

CDISC is pleased to announce that The Protocol Representation Model Version 1.0 final version is now available for download.

The CDISC Protocol Representation Model Version 1.0 (PRM V1.0) is intended for those involved in the planning and design of a research protocol. The model focuses on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs".  PRM V1.0 also includes the definitions of the roles that participate in those activities.

The scope of this model includes protocol content including Study Design, Eligibility Criteria, and the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries. The majority of business requirements were provided by subject matter experts in clinical trial protocols.

PRM V1.0 is based on the BRIDG Release 3.0 Protocol Representation sub-domain.  It includes all classes in the BRIDG Protocol Representation sub-domain plus some classes from other BRIDG sub-domains, generally classes required for ClinicalTrials.gov and the WHO registries.


CDISC Protocol Model Version 1.0  |  Non Members
Close

New CDISC Member Application

To register for a new membership, please supply the following information.

  • MEMBERSHIP OF CDISC IS NOT FREE

  • MEMBERSHIP OF CDISC IS FOR ORGANISATIONS ONLY & NOT INDIVIDUALS

Please read the details on the membership page BEFORE you apply.

Please also check that your company is not already a member of CDISC here: CDISC Members.





Please Note: These figures are for guidance only and based on company size. Further details here

If you selected Corporate Benefactor or Sponsor, enter the name and email address of CDISC Advisory Board (CAB) member.
















Thank you for your input! Please let us know how you learned about CDISC. (Check all that apply)