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Standards in this guide are end-to-end implementations of CDISC models that are designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of standards in this guide 

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Metadataspec

Standards for CollectionStandards for Tabulation: The SDTMStandards for Analysis: The ADaM

CDASH Model

  • In this guide, the CDASH Model is implemented to support development of CRFs for stusie studies that assess the impact of tobacco products on the health of individuals.
  • CDASH is the earliest model implemented in the data flow and is used support for 
  • CDASH defines a basic set of data collection fields 
  • is earlier in the data flow and defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
  • SDTM and CDASH are clearly related. The use of CDASH data collection fields and variables is intended to facilitate mapping to the SDTM structure. When submitted data can be collected as represented in an SDTM dataset, with no transformations or derivations, the SDTMIG variable names are presented in the CDASHIG metadata table and should be used to collect the data. In cases where the collected data must be transformed or reformatted prior to inclusion in an SDTM dataset, or where a corresponding SDTMIG variable does not exist, CDASH has created standardized data collection variable names. 
SDTMADaM
Standards for Data Exchange


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