Version 5.1 Application and Guidelines for Ethical Review of Clinical Trials by Ethics Committee of Zhejiang Hospital (Launched on July 1, 2020)

Version 5.1 Application and Guidelines for Ethical Review of Clinical Trials by Ethics Committee of Zhejiang Hospital (Launched on July 1, 2020)

Dear investigators and sponsors,

From July 1, 2020, the updated version 5.1 ethical application form will be adopted for some of the clinical trials of the registration application of the Ethics Committee of Zhejiang Hospital, you are kindly required to submit your application materials in accordance with the updated application guidelines and forms. Thanks for your understanding. The version 5.1 ethical application guidelines and forms are as follows：

1.List of Materials for Submission by Ethics Committee of Zhejiang Hospital

2.Review Fee Rates and Invoicing Instructions by Ethics Committee of Zhejiang Hospital

3. Ethical Review Fee Agreement Model by Ethics Committee of Zhejiang Hospital (applicable to initial, revised and re-reviewed items)

4. Application Form for Initial Review of Drug Clinical Trials by Ethics Committee of Zhejiang Hospital

5. Application Form for Initial Review of Clinical Trials of Medical Devices by Ethics Committee of Zhejiang Hospital

6. Application Form for Initial Review of Clinical Trials of IVD Reagents by Ethics Committee of Zhejiang Hospital

7. Researchers' Resume Sheet by Ethics Committee of Zhejiang Hospital

8.Statement of Responsibility of Principal Investigators by Ethics Committee of Zhejiang Hospital

9. Investigator Conflict of Interest Statement by Ethics Committee of Zhejiang Hospital

10. Amendment Review Application by Ethics Committee of Zhejiang Hospital

11. Annual or Periodic Research Progress Report by Ethics Committee of Zhejiang Hospital

12. Regular Research Progress Report by Ethics Committee of Zhejiang Hospital

13. Report Form for Serious Adverse Events or Suspected and Unexpected Severe Adverse Events by Ethics Committee of Zhejiang Hospital

14. Security Information Report Form by Ethics Committee of Zhejiang Hospital

15.Non-compliance or Contravention of Progress Report form by Ethics Committee of Zhejiang Hospital

16. Report Form on Suspension or Termination of Investigation by Ethics Committee of Zhejiang Hospital

17. Application Form for Suspension of Investigation and Re-launch by Ethics Committee of Zhejiang Hospital

18.Conclusion Report Form by Ethics Committee of Zhejiang Hospital

19. Application Form of Re-examination by Ethics Committee of Zhejiang Hospital

20. Reference Models and Guidelines by Ethics Committee of Zhejiang Hospital — Informed Consent Form

21. Reference Models and Guidelines by Ethics Committee of Zhejiang Hospital — Ethics Submission Letter

22. Powerpoint Report Requirements by Ethics Committee of Zhejiang Hospital

23. Procedures and Considerations for Ethical Review of Application for Registered Projects by Zhejiang Hospital