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Each of the original NCI Standard Case Report Forms has been mapped to (aligned with) the CDASH and SDTM standards. The mapping was The NCI Standard CRFs were not edited, changed, or updated during the CDISC alignment process. The alignment consisted of mapping the CDEs within a CRF to CDASH or SDTM standard domains and variables and creating new CDEs when needed. The mapping and CDE curation were performed using the CDASHv2.0 model and , CDASHIGv2.0 metadata table and the , SDTMv1.7 model and SDTMIGv3.3 .  As CDISC published new versions and released versions in development for public review during this work, some questions may be mapped to these newer versions.metadata table. Later versions of the CDISC standards were used for mapping and curation when appropriate. Permissible values and value meanings for the NCI Standards were retained unless the CDISC CT value set matched exactly.

NCI CBIIT will compile requests for new CT concepts and submit them The CDASH aligned CRFs contain new CDEs created for other caDSR community CDASH/SDTM CDE activities. 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 the NCIt.   When those new concepts are approved and added to CT value sets for quarterly publication, the Value Domains will be updated 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 may include CDEs which are used to collect data which is considered administrative or operational and not intended for FDA data submission. The original, harmonized NCI Standard CRF CDEs were not replaced for this type of data.

The mapping of caDSR CDEs to CDISC standards does not ensure complete conformance to the CDISC standards but is intended to make it easier for the caDSR user community to find and reuse CDEs that were created based on CDISC domain variables or supplemental variables in their data collection systems. caDSR users should work with their own CDISC subject matter expert(s) and/or FDA reviewer(s) to validate dataset submissions are conformant with the CDISC SDTM standard format.

CRF Downloads

The CDISC Aligned NCI Standard Template CRFs are organized in modules by partition category and Forms/CRF modules are intended to be used as templates for to guide the development of protocol CRFs .for data collection. Based on the CDASH standard, the CDEs allow for consistent and traceable data collection formats and structures to facilitate the creation of submission datasets using the SDTM.

A link is provided for each CRF in Microsoft Excel format. The data elements and most of the form information (such as headers, footers, instructions, and grouping of questions into modules) are included as part of the download.

This page contains links to Excel files for each CRF from the FormBuilder tool. Click on the CRF Downloads link above to access the page.

Instruction Manuals

Directions The instruction manual is a set of directions to guide data collection in each module template is provided in each CRF Instruction Manual. Specific implementation instructions are not present; various groups may wish to implement the contents of a module in a variety of software applications. The instruction manuals also contain mapping instruction and annotations for the CDASH and/or SDTM mappings used for each CDE where appropriate.

The instructions include mapping guidance for CDASH and SDTM domains, the field name, description or definition of each field, CDISC mapping instructions, and any special formatting notes that apply to entries such as the inclusion of full dates, use of values from a choice list only, etc. Each question is noted as Mandatory (m), Conditional (c), or Optional (o) and the CDE Public ID and short name is provided.

An annotated CRF is also provided to show the CDISC mappings. This does not include guidance for the layout of the CRFs which are organized according to the partition categories listed above.

Click on the Instruction Manuals link above to access the page.

Frequently Asked Questions

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Questions and responses are provided for some of the most common questions received from the caDSR user community

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. These questions were received through time as caDSR users worked to implement the CDISC standards in

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oncology clinical trial data collection

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. As new questions are received we will add them to this page.

Click on the Frequently Asked Questions link above to access the page.