CDISC Public Webinar - Huntington's Disease Therapeutic Area User Guide Public Review
CDISC Public Webinar - Huntingtons Disease Therapeutic Area User Guide v1.0 Public Review
Therapeutic Area User Guides (TAUG) extend the Foundational Standards to represent data that pertains to specific disease areas. TAUGs include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.
CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Version 1.0 of Huntington's Disease Therapeutic Area User Guide (HD-TAUG) describes the most common biomedical concepts relevant to HD studies and the necessary metadata to represent such data consistently, allowing datasets from multiple sources to be compared or combined for analysis. HD-TAUG v1.0 focuses on the representation of data using the Study Data Tabulation Model (SDTM). Types of data covered include family history, genetics, and biomarkers for assessing disease onset and progression. Specific biomarkers include neuroimaging assessments (MRI and PET) and biofluid biomarkers, with a focus on cerebrospinal fluid.
Date and Time
TUE, 12 SEP 2017
10:00 AM - 11:30 AM CDT
- Jon Neville, Metadata Engineer, Standards Development, CDISC
- Daniel Olson, Clinical Data Programmer, C-Path
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