CDISC PRM Toolset v1

CDISC PRM Toolset Version 1.0

 

The CDISC Protocol Representation Group is pleased to announce the availability of Version 1.0 of the CDISC Protocol Representation Model (PRM) Toolset, freely accessible on the CDISC website http://www.cdisc.org/protocol.

 

We have focused the initial release of the Toolset on the Clinical Study Outline. Within the industry, the Study Outline is also sometimes also referred to as the "Study Synopsis", or "Study Concept Sheet". The intended use is to provide an outline of the key concepts which define the study design prior to commencing authorship of the Protocol Document and related downstream activities such as the Data Collection Specification and CRF Design. The Study Outline is typically created for each study, and follows a Clinical Development Plan. Once reviewed and approved, the Clinical Protocol design process is initiated.

 

The purpose of the Toolset is to provide an evolving set of tools to assist organizations in implementing the use of the CDISC PRM V1.0 standard. This first release provides the two tools described below.

 

 

Study Outline Document Template

 

Conceptually, the Study Outline document facilitates review and agreement of an initial set of core study design parameters and attributes. These design elements include, as an example, Study Phase, Study Objectives, Study Endpoints and/or Outcomes, and Inclusion/Exclusion Criteria. Agreement upon these core concepts then drives the remaining content of the study design and ultimately the protocol, related documents, and various downstream activities and systems.

 

The CDISC Study Outline Document Template is a Microsoft Word 2007 document template that formats and presents the Study Outline Concepts List in document form. The document is ultimately the vehicle by which the Study Outline will be communicated to the study team and/or accountable parties. It is important to note that the document provides a visible and tangible means to implement the use of the Study Outline Concepts standard.

 

The intended use of this tool is to provide organizations a starting point for standardizing the Study Outline document within their respective organization. Conceptually, the CDISC template is to be considered the minimum set of suggested concepts, and organizations should feel free to expand as they see necessary for their needs.

 

Please note the document template provided is currently supported only with Microsoft Word version 2007 or above, and is not currently compatible with the Apple MacIntosh OS.

 

Follow the link to access the Study Outline Word Template. 

 

 

Study Outline Concepts List

 

The CDISC Study Outline Concepts List is a reference list of the individual concepts mapped to the superset of study design concepts (PRG Concepts Master) and related CDISC SDTM TS Domain standard TSPARMCD's. Mapping to the BRIDG model is also provided by way of the PRG Master Concept.

 

The intended use of this tool is to provide organizations a detailed mapping between the Study Outline Concepts, BRIDG, and SDTM and to serve as a reference which includes further explanation of the concepts and any related notes. This will help sponsors understand how the information entered into the Study Outline Document aligns and maps to both the BRIDG and SDTM standards in order to assist standardizing study design data across the various steps of the study lifecycle. As an example, the Study Phase selected in the Study Outline Document inherently is standardized with SDTM and CDASH, as well as any systems implemented using the BRIDG Domain Analysis model.

 

Follow the link to access the Study Outline Concepts.

 

 

 

Compatibility Requirements

 

The PRM Toolset Version 1.0 is compatible with CDISC SDTMIG version 3.1.2 and BRIDG version 3.0.3. Subsequent versions of the PRM Toolset will provide updated mappings and/or concepts as necessary to align with newer releases of both BRIDG and SDTM.

 

The Study Outline document requires Microsoft Word version 2007 or above, and is not yet available for the Apple MacIntosh OS.

 

 

Next Steps

 

The CDISC PRM Toolset is intended to be part of an evolving set of tools which maintain consistency and adherence to the related CDISC standards. Among future offerings planned are the web-based CDISC PRM Wizard tool which will allow users to enter their study concepts through an intuitive web page interface, and then produce output files such as the study SDTM Trial Summary Domain Dataset and an ODM XML file containing the study concept information. The ODM may then be transformed for XML-based submissions to trial registries and data repositories.

 

The core principle guiding the Toolset evolution is to provide a means to implement the use of the PRM standard for not only the Study Outline, but the Clinical Protocol in its entirety. The CDISC PRG team has intentionally restricted the scope of the initial release to allow users to gain easy, early exposure to the PRM, and ensure we are aligned with industry needs and able to accommodate feedback as the Toolsets are deployed.