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CDISC standards applicable to data collection, representation, and analysis for each use case category are summarized in the table below.
Product Description, for use cases which characterize a product
- Trial Design, for standards which describe the design of a study
- Nonclinical, for both in vitro and in vivo nonclinical study use cases
- Product Impact on Individual Health, for use cases to assess the impact on of a product on individuals
- Product Impact on Population Health, for use cases to assess the impact of a product on a population of individuals
CDASH standards for collection, SEND and SDTM standards for data tabulation, and ADaM standards for creation of analysis datasets organize data ...
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