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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 studies that assess the impact of tobacco products on the health of individuals.the 
  • CDASH is the earliest model implemented in the data flow for for Although not formally addressed in the TIG, the principles and metadata presented can be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards and ePRO data structures, as applicable. 
  • 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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