Table 2 Categories and features for project approval and review management of clinical trials
From: Development of an integrated and comprehensive clinical trial process management system
Category | Features | Description |
|---|---|---|
Study project management | Project approval management | CTI defines the application and review procedures for study projects according to the standard operation procedure (SOP) |
To-do tasks list | Lists the tasks that the user needs to complete, which are automatically generated by the system according to processes and user roles | |
Project list | Project list contains basic information about the study, controlling different viewing scopes for different roles | |
Document management | Electronic management of documents, batch uploading, online review, and suggestion feedback | |
Contract management | Manages the content and budget of the contract, and supervises the execution of the contract | |
Initial meeting management | Records the meeting contents and participants of the initial meeting | |
Investigator management | Manages investigators’ Good Clinical Practice (GCP) education, resume, etc | |
Clinical research coordinator (CRC) management | Manages CRC personnel information, recruitment process, and workload reporting and review | |
Ethics management | Ethics committee (EC) | Manages the organizational structure of the EC |
Ethics review management | Manages the ethics review process, including ethical review application, formal review, study assessment, ethics conference review, approval letter generation, etc | |
Ethics conference management | Manages the project review agenda, meeting attendance, voting, meeting minutes, project review results, etc |