Development of an integrated and comprehensive clinical trial process management system

Abstract

Background: The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection.

Methods: The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information.

Results: The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine.

Conclusion: The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.

Keywords: Clinical trial; Clinical trial management system (CTMS); Information technology; Integrated management system; Medical informatics.

Fig. 1

System architecture for the clinical trial management system (CTMS). HIS: hospital information system; EMR: electronic medical record; LIS: laboratory information system; CDR: clinical data repository; PACS: picture archiving and communication systems

Fig. 2

Process management system further categorized into 59 internal processes by combining user and authority management. CRA: clinical research associate; CRC: clinical research coordinator; CTI: clinical trial institutes; PI: principal investigator; EC: ethics committee

Fig. 3

Critical services for data integration between the clinical trial management system (CTMS) and external systems. HIS: hospital information system; EMR: electronic medical record; LIS: laboratory information system; CDR: clinical data repository; ETL: extract-transform-load; MQ: message queue; RPC: remote procedure call; CTMS: clinical trial management system; PMMS: permission management and maintenance system; CTSMS: clinical trial subject management system; CTIPMS: clinical trial investigational product management system; CTFMS: clinical trial financial management system; CTSMS: clinical trial subject management system; CTQMS: clinical trial quality management system

Fig. 4

Change in the number of subjects and corresponding study projects enrolled in the clinical trial management system (CTMS) over the last two years