Clinical Data Interchange Standards Consortium Standardization of Biobank Data: A Feasibility Study.

The National Center Biobank Network (NCBN), consisting of six national centers (NCs) for advanced and specialized medical care, was launched in Japan in 2012 to collect biological specimens and health-related data. The common data formats of the six NCs, however, are not widely known outside the NCs. Therefore, we investigated whether the data elements collected by the NCBN could be made to conform to the international standards of the Clinical Data Interchange Standards Consortium (CDISC). We attempted to map the NCBN data elements (202 items) onto the Study Data Tabulation Model (SDTM), a set of CDISC standards on the submission format of electronic clinical data approved by the Food and Drug Administration. The results showed that all 202 items of the NCBN data could be mapped onto the SDTM and fulfilled 50%-70% of the required items of each domain specified in the SDTM. We concluded that, while the standardization of biobank data according to the CDISC standards is possible, there is a need to consider whether additional items must be included in the NCBN and to have experts familiar with the CDISC standards review the standardization needs.