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Each of the original NCI Standard Case Report Forms (CRF Modules) has been mapped to (aligned with) the CDASH and SDTM standards. The mapping was performed using the CDASH v2CDASHv2.0 model and CDASHIG v2CDASHIGv2.0 metadata table and the SDTM v1SDTMv1.7 model and SDTMIG v3SDTMIGv3.3.  As CDISC published new versions and released versions in development for public review during this work, some content questions may be mapped to these newer versions.

The CDASH aligned CRFs contain new CDEs created for other caDSR community CDASH/SDTM CDE activities and additional . Additional new CDEs were created where the NCI Standard list of values do not match the current CDISC Controlled Terminology Value Sets.  NCI CBIIT is compiling and sending in new CT requests to EVS for review and inclusion in NCIt.  When those concepts are approved and added to CT value sets for quarterly publication, the CDEs Value Domains will be versioned and the Value Domains will be updated accordinglyupdated according to caDSR Business Rules and any associated CDEs with Released Workflow Status will be versioned.  If the CRF questions and their responses are for CRF operational or administrative purposes and the data collected is not intended for submission to FDA, the original, harmonized and standardized CDEs were retained in the CRF module.

The NCI Standard CRFs are organized in modules by partition category and are intended to be used as templates for the development of protocol CRFs.  The instruction manual is a set of directions to guide data collection in each module template. Specific implementation instructions are not present; various groups may wish to implement the contents of a module in a variety of software applications.

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