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薬理と治療
Abstract
To improve clinical research efficiency, it is necessary to utilize various information systems, including electronic data capture(EDC)systems. However, it is difficult to appropriately manage EDC systems in an academic institution because commercial EDC systems are often cost-prohibitive, and to safely and effectively manage EDC systems, network-level countermeasures and institutional-level activities are required. REDCap is one of the global, standard -free EDC systems for investigator-initiated clinical researches. Here, we introduce our REDCap and computer system validation project to improve the efficiency of clinical research. We developed a four-tier in-hospital network at our center according to the confidentiality level of the information associated with our institution. The tier-one demilitarized zone network was used to deploy the EDC system for multisite clinical research. The tiertwo network was used for ordinary research and administrative purposes related to the internet. Further, the tier-three network was used for clinical research databases and documents, and the tier-four network was for hospital information systems, including the electronic medical records system. We introduced the REDCap system at the appropriate infrastructure tiers. After introduction, we executed computer system validation using a validation plan, user requirement specification, confirmation of functional specification, and other validation measures that were created in our institution. In addition, standard operating procedures were established to execute the operation of the system and to maintain it appropriately. The REDCap system was introduced without major problems. We believe that introducing the REDCap system in institutions will improve the effectiveness of investigator-initiated clinical researches in Japan.
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