Feasibility of Converting Data of National Center Biobank Network Catalog to Analysis Data Model

Abstract

In Japan, the National Center Biobank Network (NCBN), comprising six National Centers (NCs), is one of several operating biobank projects that were launched in 2012 as a clinical basic facility project for next-generation medicine. The NCBN is a network-type and federal-type morphological biobank that uses wide-ranging joint research projects to provide bioresources in cooperation with industry, academia, and the government. 5) Information related to biological specimens (blood, deoxyribonucleic acid[DNA], ribonucleic acid[RNA], blood serum, etc.)is collected and stored at each NC, and patient medical data are collected and controlled at a central biobank in a searchable database. 6) However, at present, limited information can be shared among the six NCs, which is mainly due to the lack of standardization of this information in a universal data format. This variation in data formats has caused many problems for collections at the central biobank owing to independent interpretations at each NC and non-compliant entry methods. Consequently, the NCBN catalog data are not currently utilized by outside researchers. The Clinical Data Interchange Standards Consortium (CDISC) standards are a collection of standard specifications regulated by the CDISC, such as definitions of clinical trial content, communications protocols, and standard formats for electronic application data. In 2004, the U.S. Food and Drug 臨床薬理 Jpn J Clin Pharmacol Ther 2017; 48(3): 95-98 95