Table 4 Categories and features for backstage management of clinical trials
From: Development of an integrated and comprehensive clinical trial process management system
Category | Features | Description |
|---|---|---|
User and permission management | User registration | Non-hospital users apply for registration and approval mode (such as clinical research coordinator (CRC) and clinical research associate (CRA)) |
User list | User list contains all the users in the system, managing login policies and permissions | |
Permission management | Realizes the role-based authority management system | |
Log management | System log | Includes system operation and data change logs, traceable to the source of changes |
Data dictionary management | Basic data maintenance | Basic data support for the operation of the clinical trial management system (CTMS) can be maintained through a graphical interface |
Basic data synchronization | Sets up synchronization task; part of the basic data is automatically obtained from other business systems by means of timing synchronization | |
Data statistics | Data statistics | Statistical analysis capabilities of various data, support tables, and graphs |
System settings | System settings | System customization functions to enable the system to operate more intelligently (such as messages and templates) |