CDISC models used to standardize data collection, data tabulation, and creation of analysis datasets for each use case category are summarized below.
| Category | Standards for Collection | Standards for Tabulation | Analysis |
|---|---|---|---|
| Product Description | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) | |
| 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) |
All models implemented as part of this guide collect and represent data by common topics with:
- CDASH and SDTM grouping logically related data points called domains; and
- ADaM dataset design customizable to support analysis requirements.
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