Clinical Trial Implementation Process of Zhejiang University

Clinical Trial Implementation Process of Zhejiang University

Instructions on General Process for Project Initiation, Implementation and Conclusion

1. At Zhejiang Hospital, the project approval of institutions is done via the GCP management platform (http://61.175.192.169:1100/). New users have to go to this website for applying for an account, which can be activated upon approval by institutions;

2. Pre-approval: Log into the GCP management platform (http://61.175.192.169:1100/) for submitting application materials for pre-approval, which is completed by three-time confirmation by the secretaries of institutions, principal investigators of projects, and the secretaries of institutions, withing five working days in an event of no serious issues;

3. Project initiation: Log into the GCP management platform (http://61.175.192.169:1100/)for re-submitting the application materials for approval and initiation, which is completed by twice confirmation by the secretaries of institutions and office directors of institutions, within five working days in an event of no serious issues;

4. Ethical approval: (Ethics Office Contact: 0571-81595231) Ethics meetings are held in mid to late month;

5. Contract review (main contract and CRC contract): The contracts will be reviewed by offices of institutions and signed at the hospital meeting (within 10 working days);

6. Contract signing (within five working days)

7. Office of Genetics' commitment signing (within five days)

8. Project kick-off meeting: The applicants, professional departments, and offices of institutions will decide the time of the kick-off meeting and notify personnel of institutions to attend, after their confirmation on the preparations for the project kick-off.

9. Clinical trial project implementation: (1) CRA/CRC must sign in at institutions during its visit after its qualification recognized by institutions. (2) The free inspection during the trial has to be conducted via the GCP management platform (http://192.16.1.146/). (3) The occurrence of program violations or SAE incidents should be reported to the institutions, which will report them to the provincial office. (4) It should be filed the drug combination and inspection traceability at institutions for inquiry. (5) The reports of inspection and verification must be submitted to offices of institutions within working days. (6) Replacement of CRA/CRC must be approved filed by the institutions.

10. Center closure/ project conclusion: Application for center closure, documentation, submission of self-examination report, quality control of institutions, cost accounting, completion of project information collection of institutions, submission of the summary report, and submission of data to archives of institutions for retention;

Note: In case of special circumstances, the completion time of the above process will be postponed accordingly.