Practical use of a multicenter clinical research support system connected to electronic medical records

Background: Electronic medical records (EMRs) are widely used, but in many cases, they are used within a network physically separated from the Internet. Multicenter clinical studies use Internet-connected elec-tronic data capture (EDC) systems to collect data, where data entered into the EMR are manually tran-scribed into the EDC system. In addition, medical images for clinical research are also collected manually. Variations in EMRs and differing data structures among vendors hamper the use of data for clinical re-search. Methods: We solved this problem by developing a network infrastructure for clinical research between Osaka University Hospital and affiliated hospitals in the Osaka area and introducing a clinical data collec-tion system (CDCS). In each hospital's EMR network, we implemented a CRF reporter that accumulated data for clinical research using a template and then sent the data to a management server in the Osaka University Hospital Data Center. To organize the patient profile data and clinical laboratory data stored in each EMR for use in clinical research, the data are retrieved from the template by an interface module developed by each vendor, according to our common data output interface specification. The data entered into the CRF reporter template for clinical research are also recorded in the EMR progress notes and sent to the data management server. This network infrastructure can also be used as a medical image collec-tion system that automatically collects images for research from PACS at each hospital. These systems are managed under common subject numbers issued by the CDCS. Results: A network infrastructure was established among 19 hospitals, and a CRF reporter was incor-porated into the EMR. A medical image transfer system was introduced in 13 hospitals. Since 2013, 28 clinical studies have been conducted using this system, and data for 9,987 cases have been collected as of December 31, 2020. Conclusion: Incorporating a CRF reporter with medical image transfer system into the EMR has proven useful for collecting research data. C 2021 Elsevier B.V. All rights reserved.