In 2006, members of the National Cancer Institute’s Center for Biomedical Informatics and Information Technology (NCI CBIIT) in conjunction with the cancer Data Standards Registry and Repository (caDSR) user community initiated a Case Report Form (CRF) harmonization activity. CRFs submitted from the community were reviewed and inventoried. The Harmonization group then reviewed all questions on the CRF and partitioned them into categories:
- Mandatory – A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)).
- Conditional – A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules.
- Optional – A data collection variable that is available for use if needed. There is no regulatory or business requirement for inclusion of this element on the CRF; if the design and scientific questions posed in the study dictate the need to collect this type of data; this is the element to include on the CRF.
A template form with modules that contain questions representing data to be collected and a companion electronic CRF instruction manual was developed. These CRF modules were vetted and adopted by the caDSR stakeholder community as metadata standards.
Since the original CRFs and manuals were adopted, the Food & Drug Administration (FDA) published guidelines for submission of clinical trial study data using the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) for Investigational New Drug (IND) trials starting after December 2017. In response, NCI CBIIT has aligned the NCI Standard CRF modules with the CDISC data collection standard, Clinical Data Acquisition Standards Harmonization (CDASH) where data is expected to be submitted to FDA in SDTM format.
Each of the original NCI Standard Case Report Forms (CRF Modules) has been mapped to the CDASH and SDTM standards. The mapping was performed using the CDASH v2.0 model and CDASHIG v2.0 metadata table and the SDTM v1.7 model and SDTMIG v3.3. As CDISC published new versions and released versions in development for public review, some content may be mapped to these newer versions. The CDASH aligned CRFs contain new CDEs created for caDSR community CDASH/SDTM CDE activities and additional new CDEs 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 will be versioned and the Value Domains will be updated accordingly. 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 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.
CRF Downloads
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Instruction Manuals
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Frequently Asked Questions
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