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Standards in this guide are aligned with both use cases and activities. Given this, determining which standards to use may begin by selecting standards in this guide by for the use case and activity to be supported. It recommended that all guidance is reviewed, both high-level and detailed, prior to implementing standards. For ease of use, the table below presents use cases, activities, and corresponding sections in this guide in which provide detailed instructions for implementation. It It is recommended that all sections are read before the sections below  Sections referenced in this table Detailed sections referenced are:

  • Section x.x, Standards for Collection to , to guide development and use of case report forms (CRFs) by implementing the CDISC CDASH Model.
  • Section x.x, Standards for Tabulation, to guide organization of data collected, assigned, or derived for a study by implementing SDTM.
  • Section x.x, Standards for Analysis, to 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, to support sharing of structured data between parties and across different information systems by implementing specified standard specifications and resources. 

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Metadataspec
Use caseData CollectionData TabulationData AnalysisData Exchange
Product Description 


Section x.x, Standards for Tabulation

Section x.x, Standards for AnalysisAnalysis 


Section x.x, Standards for Data Exchange

Nonclinical
Product Impact on Individual HealthSection x.x, Standards for Collection
Section x.x, Standards for AnalysisAnalysis 
Product Impact on Population Health

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