Protocol Representation Model (Protocol) v1.0
Protocol v1.0 provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries), and EudraCT registries. Protocol v1.0 assists in automating CRF creation and EHR configuration to support clinical research and data sharing.
Protocol v1.0 was developed to support: a) protocol document generation; b) research study (clinical trial) registration and tracking; c) regulatory oversight and review; and d) single-sourced, downstream electronic consumption of protocol content, allowing users to create and quality control content once, and reuse for trial registries, protocol and case study report templates, SDTM study design and more.
Protocol Toolset v1.0
The Protocol Toolset v1.0 provides the following tools to assist in implementation:
- Study Outline Document Template - A template of suggested concepts for standardizing the Study Outline document.
- Study Outline Concepts List - A detailed mapping between the Study Outline Concepts, BRIDG, and the SDTM Trial Summary Domain to serve as a reference for further explanation of the concepts and any related notes.
Protocol Wizard Web Demonstration Tool
The Protocol Wizard Web Demonstration Tool produces a sample Study Outline document and related SDTM domains as defined in the CDISC Protocol Study Outline in the CDISC Protocol Toolset v1.0 and applicable SDTMIG trial design domains (both TS and TI Domains). This tool is provided for exploratory use as a proof-of-concept example implementation of the CDISC Protocol standard.