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Standard(s) to Implement by Use Case

This section guides the selection of standards to used based on:

  • Tobacco product study use cases covered in this guide.
  • The purpose of a standard model in relation to these use cases.

The table below relates use cases to models implemented in the TIG.


Metadataspec
Use caseStandards for CollectionStandards for TabulationStandards 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
)
Model 
Study Data Tabulation Model (
SDTM
)
Analysis Data Model (
ADaM
)

Product Impact on Population Health
Analysis Data Model (


ADaM
)



CDASH:

Throughout this document, a deliberate decision was made to use a variety of synonyms for various terms in order to reflect the fact that sponsors also use a variety of terms.

...