- Protocol Representation Home on the CDISC Website
- Protocol Representation Home on the CDISC Wiki (Access may be restricted to Protocol Team Members)
- 2015 CDISC Technical Plan
Leadership Team David Gemzik (Medidata Solutions) – dgemzik@mdsol.com Melissa Cook (Accenture) - melissa.k.cook@accenture.com |
Team Characteristics The PRG team is comprised of volunteer experts who can contribute to its various sub-teams with their technical or Therapeutic-based subject matter expertise. Volunteers Needed! Working knowledge of clinical study design and protocol content. Interest in leveraging structured protocol standards to facilitate subject recruitment, accelerate the clinical research process and improve review and analysis of research data. |
| The protocol standard must be both machine-readable and easily under-stood by its users, notably clinicians, medical writers, regulatory authorities, IRBs, statisticians, project managers, and site personnel. The machine-readable representation should be transparent to end-users listed above. Alignment with all CDISC standards through the BRIDG model and non-CDISC industry standards (where applicable) must be demonstrated. |
Team Mission Development and publication of standard, structured, protocol concepts and content that will enable interchange and reuse of protocol-required data and metadata among systems, stakeholders, and operations staff throughout the lifecycle of the study. |
History The team was initiated in 2002 and first explored ICH E3, E6 and E9 and other global protocol requirements. Next, the team developed a spreadsheet containing an outline, hierarchy and elements that are common across protocols that were harmonized into the BRIDG domain analysis model. This established a framework for conducting end-to-end protocol-driven clinical research in a standards-based environment and support semantic consistency and interoperability. PRM V1.0 was released in January 2010 as a set of BRIDG classes and attributes related to study and protocol design. PRM elements and standard templates are harmonized with the BRIDG model to ensure semantic consistency and support interoperability with other accepted standards. In 2012, the PRG team released the PRM Toolset V1.0 targeting the Clinical Study Outline content and standard implementation. The Toolset included a set of study outline concepts mapped to BRIDG and SDTM, a Document Template representing a presentation of the standard concepts, and the Protocol Wizard Demonstration Tool. The Protocol Wizard is a web-based tool that allows users to create a standard Study Outline document as well as export the TS and TI SDTM tabulations from a single web interface. It is freely available at https://cdiscprm-sandbox.imedidata.net/ |
Sub Teams
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2014 Deliverables
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Stakeholders/Constituency
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Collaborations
Team Dependencies Study Design (SDS sub team), BRIDG, Glossary, Terminology, XML Technologies |
Operating Model & Meetings Meeting every two weeks on Thursdays via telecon at +1 415 363 0833 / PIN 202675 Contact dgemzik@mdsol.com for calendar invitation |