1 |
Supply of Enterprise Qualification, IFU and Test Report |
2 |
Signing of Clinical Agency Service Agreement |
3 | Draft of Clinical Trial Scheme |
4 | Selection of Test Center |
5 | Ethical Review |
6 | Clinical Trial Review and Approval (if necessary) |
7 | Signing of Clinical Agreement with Hospital |
8 | Application for Clinical Filing to Provincial Food and Drug Administration by Applicant |
9 | Initiation of Clinical Trial |
10 | Supervision and Follow-up during Clinical Trial |
11 | Statistics and Data Management |
12 | Review Conference for Clinical Trial Summary Report |
13 | Compilation of Clinical Trial Summary Report |