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  • Standards for Collection implement the CDASH Model to support development and use of case report forms (CRFs).
  • Standards for Tabulation implement the SDTM to organize data collected, assigned, or derived in datasets.
  • Standards for Analysis implement the ADaM to specify the principles to follow in the creation of analysis datasets and associated metadata.
  • Standards for Data Exchange and with associated resources support the sharing of structured data between parties and across different information systems.

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

Metadataspec
Use caseStandards for CollectionStandards for TabulationStandards for AnalysisStandards for Data Exchange
Product Description 
SDTMADaMDefine-XML
Nonclinical
SDTM
Define-XML
Product Impact on Individual HealthCDASH Model SDTMADaMODM-XML, Define-XML
Product Impact on Population Health

ADaMDefine-XML

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