OBJECTIVES: Efficient clinical trial management has been recognized as an essential component of successful drug development. Clinical Trial Management System (CTMS) can play a key role in improving the efficiency, when interoperability with other information systems related to clinical trials is guaranteed. We aimed to develop nationwide interoperable CTMS and optimize the system to various clinical trial sites in Korea.

METHODS: We selected essential functionalities for CTMS and defined common data structure of the entire Institutional Review Boards (IRBs) in Korea. Then we developed CTMS with standardized interoperable data structures and data conversion module between CTMS and IRB database. After the prototype CTMS was constructed, we installed CTMS in local clinical trial centers. User acceptance testing (UAT) was conducted and CTMS was optimized based on the UAT results.

RESULTS: The final CTMS comprised key functionalities including statistics module, study management module, researcher management module and site management module and electronic signature system was adopted for verification of investigators’ conducts. The data conversion module was configured on the most commonly used e-IRB system and other independent IRB systems in Korea. CTMS database was encrypted by Advanced Encryption Standard (AES) and server was installed in accordance with information security management system (ISMS) policies. UAT was successfully conducted in Seoul National University Hospital and Chonnam National University Hospital.

CONCLUSIONS: The nationwide interoperable CTMS was proven to show successful interoperability in various clinical trial centers in Korea. The CTMS is expected to facilitate efficient clinical trials especially in multi-center studies.