Protocol

PRM Document – April 2012 Page 1 Organizing and Accelerating the Clinical Research Process from the Beginning: The CDISC Protocol Representation Model and Toolkit

Overview

What is the Protocol Representation Model, and how does it affect the success of a clinical study? As we will see in this article, the Protocol Representation Model, or PRM, is of great importance, not only to data managers and statisticians, but to individuals and entities across the realm of clinical research: from the clinician, to the medical writer, to the study coordinator, to federal agencies, and eventually and most importantly, to the patient. The PRM was developed to a) support the generation of a protocol document, b) to support research study (clinical trial) registration and tracking, c) to support regulatory needs, and d) facilitate single-sourced, downstream electronic consumption of the protocol content. 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.

The Clinical Research Study Protocol

As researchers know, the protocol, in terms of a clinical research study, is the plan, or blueprint, that describes the study’s objectives, methodology, statistical considerations, and the organization of the study. Much in the way that an effective business plan lays out the foundation for what is expected in beginning a successful enterprise, a well-designed protocol is the map that is vital to the overall success of a clinical trial or study. Everyone involved in the research study needs the protocol; this includes but is not limited to the investigator, the site personnel, the clinical project managers and monitors, the data managers, and the statisticians. Additionally, the protocol is a requirement by regulatory authorities for regulated clinical research studies. A fully developed clinical protocol is essential for regulatory purposes including Investigational New Drug (IND) applications, Institutional Review Boards (IRB) and Ethics Committees. Follow the link.

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.

The purpose of the PRM 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 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.

See the link at the bottom of the page for the PRM Toolset Version 1.0

CDISC Protocol Representation Model

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.