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At the highest level, sets of standards in this guide are aligned with both tobacco study use cases and by the activities in the data life cycle data related processes they support. In the TIG:  

  • Standards for Collection will be used to implement the CDASH Model to support guide development and use of case report forms (CRFs) by implementing the CDISC CDASH Model.
  • Standards for Tabulation will be used to implement the SDTM to organize guide organization of data collected, assigned, or derived in datasetsfor a study by implementing SDTM.
  • Standards for Analysis will be used to implement the ADaM to specify the principles to follow in the creation of analysis datasets and associated metadata by implementing the ADaM. 
  • Standards for Data Exchange with associated resources will support the sharing of structured data between parties and across different information systems by implementing specified standard specifications and resources.  

Use cases, activities, and associated sets of standards in scope for this guide are shown in the table below.

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