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| Category | Standards for Collection | Standards for Tabulation | Standards for 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) |
How collection, tabulation, and analysis standards are related.
SDTM
Observations about study subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Each domain is represented by a single dataset.
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Overview
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