01
Study Protocol & CRF Development
We support the design of study protocols and Case Report Forms (CRFs) from the upstream stages, from a data management perspective.
Joint Center for Researchers, Associates and Clinicians
JCRAC is a team of
data management and IT professionals.
Drawing on the expertise built through more than 20 years of experience, we provide end-to-end support for clinical research data management — from developing study protocols, through centralized monitoring with an EDC system, to finalizing datasets ready for data analysis.
Greeting
Message from the Director
Director, Department of Joint Center for Researchers, Associates and Clinicians (JCRAC), Center for Clinical Sciences
Hajime Ohyanagi
As the division that operates a clinical data center, JCRAC has accumulated, through more than 20 years of experience, the problem-solving capabilities to address the scientific and practical challenges that arise in conducting multicenter collaborative studies.
Building on this expertise and track record, we join research projects from the upstream stages — such as developing study protocols and Case Report Forms (CRFs) — carry out data management (data quality control) including data cleaning through centralized monitoring with an Electronic Data Capture (EDC) system, and aim to deliver high-quality datasets prepared with the final data analysis in mind.
Services
Services
From developing study protocols and CRFs to finalizing datasets ready for analysis, we provide end-to-end support for clinical research data management.
02
EDC Setup & Database Building
Centered on Da Capo, our in-house EDC system, we configure the EDC and build databases tailored to each study.
03
Participant Registration & Allocation
We support participant registration and allocation management in multicenter collaborative studies, on both the system and operational sides.
04
Data Management
Through data cleaning, query management, and centralized monitoring, we produce high-quality datasets prepared with analysis in mind.
EDC System
Da Capo, Our In-House EDC System
Because Da Capo is developed in-house, it is free of license restrictions and can also be used when supporting research at external institutions. It is easy to extend, and we continually develop and add features that conventional EDC systems lack. Depending on the characteristics of each study, we also offer configurations that combine Da Capo with REDCap, a general-purpose EDC.
Our work is carried out in accordance with 19 standard operating procedures (SOPs) and manuals, ensuring quality and reproducibility.
Certifications
Certified to International Standards ISO/IEC 27001 and ISO 9001
With international certifications in both information security and quality, we maintain a framework to support clinical research, including clinical trials for regulatory approval, as an Academic Research Organization (ARO).
ISO/IEC 27001 Certified in 2022
To protect the information assets related to our clinical research data management operations from security threats, we have established and continue to operate an information security management system (ISMS) that meets the requirements of ISO/IEC 27001.
ISO 9001 Certified in 2025
We have obtained certification for a quality management system (QMS) that meets the requirements of ISO 9001. By formalizing the standardization and continual improvement of our business processes based on the international standard, we further strengthen our quality assurance framework.
History
History
Since its establishment, JCRAC has operated under the guidance of a group of researchers at the National Center for Global Health and Medicine (NCGM, now the Japan Institute for Health Security, JIHS).
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2001
Founded as the Japan Clinical Research Data Center within the Society of Japanese Pharmacopoeia (now the Pharmaceutical and Medical Device Regulatory Science Society of Japan, PMRJ) as part of the Millennium Project, under the name JCRAC (Japan Clinical Research Assist Center).
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2006
Moved its organizational base to the Japan Foundation for the Promotion of International Medical Research Cooperation (dissolved on July 1, 2013) and continued operations as JCRAC.
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2011
Operations were transferred to the Center for Clinical Sciences, NCGM, and JCRAC was relaunched as the Joint Center for Researchers, Associates and Clinicians.
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2023
Reorganized and strengthened as JCRAC, comprising two offices: the Office of Clinical Data Management and the Office of Bioinformatics.
Organization
Organizational Structure
Department of Joint Center for Researchers, Associates and Clinicians (JCRAC)
Director: Hajime Ohyanagi
Office of Clinical Data Management
To ensure the reliability and quality of research results, we conduct data management in a scientific and logical manner, managing not only outcomes but also processes. The office is responsible for study protocol and CRF development, EDC setup, participant registration and allocation management, and data management operations.
Office of Bioinformatics
The office operates and manages our on-premises EDC systems (REDCap and Da Capo) and the IT infrastructure, including departmental PCs and networks. While developing and maintaining an information security management system (ISMS) based on ISO/IEC 27001, it also pursues its own research on genome and omics studies using bioinformatics technologies and on applying AI technologies to data management operations.
Consultations & Inquiries
We welcome inquiries about data management for clinical research.