Standards in this guide are end-to-end implementations of CDISC models 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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| Standards for Collection | Standards for Tabulation: The SDTM | Standards for Analysis: The ADaM |
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The CDASH Model - In this guide,
- CDASH is the earliest model implemented in the data flow and is used support
- 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.
| The SDTM | The ADaM | | Standards for Data Exchange |
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