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Sets of data standards in this guide are aligned with both use cases and activities. Given this, determining which standards to use may begin by selecting standards for the use case and activity to be supported. All TIG guidance should be reviewed, both general and detailed, prior to implementing standards. For ease of use, the table below presents use cases, activities, and corresponding sections in this guide which provide detailed instructions for implementation. Detailed instructions referenced are:

  • Section x.x, Standards for Collection, which guides development and use of case report forms (CRFs) by implementing the CDISC CDASH Model.
  • Section x.x, Standards for Tabulation, which guides organization of data collected, assigned, or derived for a study by implementing SDTM.
  • Section x.x, Standards for Analysis, which specify the principles to follow in the creation of analysis datasets and associated metadata by implementing the ADaM.
  • Section x.x, Standards for Data Exchange, which support sharing of structured data between parties and across different information systems by implementing specified standards and resources. 

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