Webinar Description:
The CDISC Protocol Representation Model (PRM) V1 has been developed to facilitate the exchange of clinical research data, allowing studies to be initiated more rapidly, and supporting machine- and human-understandable decision support. . The PRM is aligned with the Biomedical Research Integrated Domain Group (BRIDG) Model, a model that represents protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare. This session will provide an overview of the model and its contents which include the flowing areas:
- Common Protocol Information – this includes the basic information about the study, the study document and the people and organizations involved
- Clinical Trial Registry (CTR) – this includes the information/elements for trial registration (e.g. for EudraCT, clinicaltrials.gov or the WHO International Clinical Trial Registry Platform) protocol/study tracking for management purposes, and study summary information from SDTM
- Eligibility Criteria – the basic criteria for inclusion and exclusion of a subject in a study
- Study Design – including experimental design (arms and epochs) and the schedule of activities (visits and planned assessments and interventions)
The session will also include a discussion of the plans and uses of the PRM.
Presenters:
Lisa Chatterjee, Vice President, Healthcare Data Standards, Digital Infusion, Inc
David Gemzik, Vice President, Implementation Services Medidata Solutions