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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 | 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) |
...
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