CDISC models used to standardize data collection, data tabulation, and creation of analysis datasets for each use case category are summarized below. All models implemented as part of this guide collect and represent data by common topics with:
- CDASH and SDTM organizing related data points in groupings called domains; and
- ADaM dataset design customized to support analysis requirements.
Category | Collection | Tabulation | Analysis |
---|---|---|---|
Product Description | Study Data Tabulation Model (SDTM) | ||
Nonclinical | Study Data Tabulation Model (SDTM) | ||
Product Impact on Individual Health | Clinical Data Acquisition Standards Harmonization (CDASH) | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) |
Product Impact on Population Health | Analysis Data Model (ADaM) |
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