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 has been mapped to (aligned with) the CDASH and SDTM standards. The mapping was 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.
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 NCIt. When those 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.
CRF Downloads
The NCI Standard Template CRFs are organized in modules by partition category and are intended to be used as templates for the development of protocol CRFs. 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 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. Click on the Instruction Manuals link above to access the page.
Frequently Asked Questions
Responses are provided for some of the most common questions received from the caDSR user community as groups work to implement the CDISC standards in their data collection systems. Click on the Frequently Asked Questions link above to access the page.
