Development of an integrated and comprehensive clinical trial process management system

Area of Science:

• Clinical research informatics
• Health information systems
• Biomedical data management

Background:

• Clinical drug trials in hospitals face significant institutional, technical, and record-keeping challenges.
• An integrated Clinical Trial Management System (CTMS) was independently developed to address these complexities.
• The CTMS incorporates system development methodologies, external system integration, standardization protocols, and robust data security measures.

Purpose of the Study:

• To develop and implement an integrated Clinical Trial Management System (CTMS) for optimizing clinical trial processes in a hospital setting.
• To create a comprehensive system for managing all phases of clinical trials, from project approval to data management.
• To enhance the efficiency, quality, and standardization of clinical trial operations.

Main Methods:

• The CTMS development involved four stages: demand analysis, system design, development/testing, and trial operation/training.
• The system features three core modules (project approval, operations management, background management) with seven subsystems and 59 internal processes.
• Integration with hospital systems (HIS, LIS, EMR, CDR) was achieved using ETL, message queues, and RPC, with strict data security and privacy protocols.

Main Results:

• The integrated CTMS was successfully deployed in September 2015 and updated to version 4.2.5 by March 2021.
• During its operation, 1388 study projects were accepted, 43,051 electronic data records were stored, and 12,144 subjects were recruited.
• The system demonstrated successful management of the entire clinical trial lifecycle within the First Affiliated Hospital, Zhejiang University School of Medicine.

Conclusions:

• The developed integrated CTMS effectively manages the complete clinical trial process.
• It provides essential infrastructure for efficient, high-quality, and standardized clinical trial operations.
• The system represents a significant advancement in clinical trial management within a hospital environment.