CDASHClinical Data Acquisition Standards Harmonization
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For variable names that were not found in either CDASH or the NINDS CDEs, the librarians developed naming conventions in consultation with the data analyst.
* CDASH = Clinical Data Acquisition Standards Harmonization
The data validation rules will be based on already developed industry standard data checks, such as SDTM data validation checks, ADaM data validation checks, define.xml checks, SEND data checks, as well as will-be-developed CDASH data validations checks and Central Lab data validation checks.
EDC capabilities like global libraries, rapid point-and-click eCRF development and test processes, and support for CDASH forms and CDISC ODM APIs, are essential."
Additionally, they have created mappings to transform healthcare standard formats, such as CCD, into pharmaceutical formats, such as CDASH. This ability allows both systems to continue functioning without major internal modifications, only requiring that external wrapper software be written to communicate and transform the data between systems.