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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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