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

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To use standards for collection and tabulation, compare the nature or role of the data to the scope of a domain. Domain names provide short descriptions of intended scope and may be used to narrow down which domains to consider. A domain standard may be used when the nature of the data and the domain scope are aligned.Observations will be collected using standardized collection fields when applicable and represented as rows in tabulation datasets. Each observation is described by a series of data points which correspond to applicable data collection fields and variables in a tabulation dataset. A data collection field and/or tabulation variable may be used when the subject matter of a data point and the scope of a field and/or variable are aligned. The majority of data for a submission will be in scope for domains based on the three General Observation Classes described in the SDTM with data also in scope for additional domains and datasets based on other SDTM classes and defined datasets. Given this, referring to both the CDASH Model when applicable and the SDTM is highly recommended when using domains as this supports to support understanding of the intended domain scope and also informs how domains may be extended or created using the SDTMto inform extensions to domains and creation of custom domains when needed.

To use standards for analysis... add text here.

Standards for data exchange are applicable to all use cases and support sharing of standard CRFs developed using collection standards, tabulation datasets generated using tabulation standards, and analysis datasets designed using analysis standards.

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