Protocol

Overview

The Protocol Representation Model, or PRM, is of great importance to all individuals and entities across the realm of clinical research: from the clinician to the medical writer, study coordinator, data managers, statisticians, regulatory agencies, and eventually and most importantly, to the patient who may be treated in a research study. The PRM was developed to support a) the generation of a protocol document, b) research study (clinical trial) registration and tracking, c) regulatory oversight and review, and d)  single-sourced, downstream electronic consumption of the protocol content under a "create once, use for multiple purposes" philosophy. This article offers background information on the history of the Protocol Representation Model and generation of PRM V 1.0, recent developments in the model, use cases for the PRM describing the business value of the PRM, description of a new Toolkit made available to users of the PRM and anticipated future progress in this area.

 

Publication (April 2012) - Organizing and Accelerating the Clinical Research Process from the Beginning: The CDISC Protocol Representation Model and Toolkit

 

 

CDISC Protocol Representation Model v1

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.

 

The CDISC PRM Toolset v1 

The purpose of the CDISC Protocol Representation Model (PRM) Toolset is to provide an evolving set of tools to assist organizations in implementing the use of the CDISC PRM standard. This first release provides two tools: the Study Outline Document Template and the Study Outline Concepts List.
 

1.  Study Outline Document Template

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.

 

2.  Study Outline Concepts List

The intended use of this tool is to provide organizations a detailed mapping between the Study Outline Concepts, BRIDG, and the SDTM Trial Summary Domain and to serve as a reference which includes further explanation of the concepts and any related notes.

 

 

Protocol Wizard Web Demonstration Tool

The CDISC Protocol Wizard Web Demonstration Tool produces an example of a Study Outline document and related SDTM domains as defined in the CDISC PRM Study
Outline provided by the CDISC PRM Toolset Version 1.0. Thecurrent version of the tool produces both a PDF output of the StudyOutline and applicable SDTMIG trial design domains (both the TS and TIDomains). This no cost demonstration tool is provided through CDISC for exploratory use as a proof of concept example implementation of the CDISC PRM standards.

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