| Standards for Collection | Standards for Tabulation: The SDTM | Standards for Analysis: The ADaM |
|---|
CDASH Model - In this guide, the CDASH Model is implemented to support development of CRFs for the the Product Impact on Individual Health use case.
- CDASH is the earliest model implemented in the data flow 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.
| SDTM | ADaM | | Standards for Data Exchange |
|
|
|
|