Services
Services
JCRAC is a data center providing comprehensive support for investigator-initiated clinical research. We become involved from the upstream stages, such as supporting study protocol development, and provide end-to-end support for clinical research data management, through to the completion of high-quality datasets ready for analysis and publication.
Drawing on the extensive data management experience we have built up, we support large-scale multicenter collaborative studies in Japan, not limited to clinical research at the Japan Institute for Health Security. In multicenter clinical studies, we become involved from the upstream stage of study protocol development and, through data management services such as participant registration, allocation management, and progress management, produce high-quality datasets with the final analysis and publication in mind.
We conduct clinical research through collaboration among experts in research methodologies such as biostatistics, clinical epidemiology, and epidemiology; data managers; support staff including clinical research coordinators (CRCs) and system engineers; and clinicians. Functioning as a data center independent of the investigators, we carry out data quality control and quality assurance.
01
Study Protocol & Case Report Form (CRF) Development Support
In supporting study protocol development, our specialist staff join the principal investigator and statistical analysts from the draft stage to examine the plan and help prepare a detailed study protocol. We also develop Case Report Forms (CRFs) based on the study protocol.
02
Participant Registration and Electronic Data Capture (EDC) System Development & Operation
We build and operate participant registration systems that make clinical data easy to enter on the web. IDs and passwords are issued to participating researchers, and entered data are kept under strict security management. In addition, an automated email system notifies participating researchers when data entry is due, helping ensure reliable data collection. An administrator interface for principal investigators and system administrators allows them to grasp progress at a glance.
Our primary EDC is Da Capo, an EDC system developed in-house, and depending on the characteristics of each study we also offer configurations that combine it with REDCap, a general-purpose EDC.
03
Data Management
We conduct centralized monitoring of participant registration status (including checks for missing or incorrectly entered data, data cleaning, process management, query management, and the preparation of monitoring reports) to deliver high-quality datasets.
04
Statistical Analysis Support
Our biostatisticians provide consultation on statistical analysis and also perform the analyses themselves.
Operations Based on Standard Operating Procedures (SOPs)
The work of JCRAC is carried out in accordance with 19 standard operating procedures (SOPs) and manuals. By standardizing our processes, we ensure quality and reproducibility so that the same level of service is delivered even when staff change.
Consultations & Inquiries
We welcome inquiries about data management for clinical research.