This quarterly webinar series addresses the latest Controlled Terminology release package as well as content currently in Public Review. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.
Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
CDISC, in collaboration with TransCelerate’s Digital Data Flow Project , is developing a reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards.
Deliverables will include a logical data model, supporting Controlled Terminology, API specifications and related conformance tests. For more information, please visit the Digital Data Flow page.
Join us for the Public Review webinar where we will:
- Introduce the draft Reference Architecture standards
- Provide information on how to submit comments
- Answer any questions you may have
Public Review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research.
Christine Connolly, Senior Project Manager, Data Standards, CDISC