The Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI), a large-scale multi-site clinical study to develop surrogate markers that lead directly to the essential process of Alzheimer's disease, was launched by All-Japan in Japan. Its goal is to develop methods for assessing the stages in the progression of Alzheimer's disease objectively and accurately through a variety of examinations, including clinical, psychological, imaging, and biochemical examinations. A variety of examinations are performed in the J-ADNI, but a large amount of money and a huge amount of effort are needed to gather such a massive amount of data and to control the data quality. To address this problem, the clinical test results must be acquired electronically and managed using a computer system. However, most existing computer systems are used only for the management of clinical findings and measurement values, and no computer systems manage not only these items but also MRI and PET image data and their imaging conditions. In this report, we propose a data checking system for the management of these items and for data quality control and describe the construction of a study management system to consolidate the management of the subjects' examination status. This will make it possible to gather the subjects' examination data appropriately and to analyze them in order to develop objective indicators. Our system manages clinical image data and the imaging protocols as well as the case report forms (CRFs) that have basically been managed by existing systems. Our findings suggest that our system will help to expand the range of applications of computer systems in large-scale multi-site clinical studies such as J-ADNI.
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