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Standards in this guide are organized by both use cases and activities. Selection of standards may begin with the use case to be addressed and activities to be supported. Use cases and activities with corresponding sections to describe guide implementation of standards are shown below where:
- Standards for Collection guide development and use of case report forms (CRFs) by implementing the CDISC CDASH Model.
- Standards for Tabulation guide organization of data collected, assigned, or derived for a study by implementing SDTM.
- Standards for Analysis specify the principles to follow in the creation of analysis datasets and associated metadata by implementing the ADaM.
- Standards for Data Exchange support sharing of structured data between parties and across different information systems by implementing specified standard specifications and resources.
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At the highest level, use cases addressed in the TIG are aligned with data-related activities supported by the standards. use cases inherent to studies of tobacco productsboth tobacco study use cases and by data related processes they support. In the TIG:
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Use cases, activities, and associated sets of standards in scope for this guide are shown in the table below.
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