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CDISC models implemented for standardization of data collection, tabulation, and creation of analysis datasets for each use case category are summarized in the table below.
| 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 |
describes how to implement CDISC models to standardize collection and representation of tobacco product study data.
| Analysis Data Model (ADaM) |
Data for CDASH standards for collection, SEND and SDTM standards for data tabulation, and ADaM standards for creation of analysis datasets organize data ...
Aside from a limited number of special-purpose domains, all subject-level SDTM datasets are based on 1 of the 3 general observation classes. When faced with a set of data that were collected and that "go together" in some sense, the first step is to identify SDTM observations within the data and the general observation class of each observation. Once these observations are identified at a high level, 2 other tasks remain:
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