Table 1 List of functional requirements for realizing the entire process management workflow of clinical trials in hospitals
From: Development of an integrated and comprehensive clinical trial process management system
No | Requirement class | Requirement description |
|---|---|---|
1 | Study Project Approval Management | The application and review of clinical trials should adopt process automation management, including process customization configuration, remote submission of project application, uploading of project materials, automatic generation of to-do tasks, timely message transmission, material annotation, and other supporting functions |
2 | Ethical Review Management | Define ethics committee review process and application contents (new protocols, protocol amendments, etc.) |
3 | Subject Management | Define the subject management model to ensure that the subjects complete the visit content of each cycle in strict accordance with the research plan |
4 | Investigational Product Management | The investigational product should adopt the central pharmacy model to achieve closed-loop management, including receiving, warehousing, distributing, recycling, returning, disposal, and early warning |
5 | Financial Management | Clinical trial finance requires independent accounting and management; the subjects’ diagnosis and treatment processes can be exempted from payment, and the system should automatically record costs to achieve direct settlement between the hospital and the sponsor |
6 | Quality Management | Define the elements and content of quality management, and the quality control of related data that must be collected during the operation of the system |
7 | Privilege Management | Involves multi-role collaboration, defining permissions and data access rules for different roles |