1. HA Central Register of Clinical Research 1 Dec 04 HA REC

2. Objectives  Collect data on investigational articles of clinical trials involving HA (facilitate safety alert / recall & related PA issues)  Provide an overview of ongoing clinical research activities within HA (sourcing review process of insurers)  Monitor trend of clinical research activities within HA & plan for required support

3. Considerations  HA REC endorsement  Acknowledge investigators by stating in application form  Administration have to ensure confidentiality  Cluster REC/IRB has to inform HA REC before accessing the data  Reporting mechanism to HA REC

4. Data  Contains 31 items obtained from the Clinical Research Ethics Review Application Form  HAREC collects data in monthly basis  Yearly report to HAREC members  Access to the database is restricted to the secretary of HAREC & personnel for administrative support

5. Contents of HA Central Register of Clinical Research (31 items) 1. Application reference number16. Study design 2. Name of Research Ethics Committee17. Investigational article 3. Study Title18. Is the test drug licensed in HK 4. Principal Investigator (PI) Title; Surname; Other name & primary institution 19. Is the study involve an additional invasive procedure 5. Is the PI a Hospital Authority (HA) staff20. Is there an independent data monitoring committee 6. Is the study a single or multi centre trial21. Primary source of funding 7. Specialty involved in study site22. Any fee income to hospital 8. Primary study site23. The alternative source of income (if applicable) 9. Is the study an international study24. Is there a external/indemnity insurance provided 10. Proposed study start date25. Phase of trial 11. Initial intended completion date26. Protocol submission date 12. Final report receipt date27. Date of REC review decision 13. Is the research a cross-cluster study with approval by another REC28. REC review decision 29. Reason for REC disapproval (if applicable) 14. Reference number of the protocol approved by another REC (if applicable) 30. Date of premature termination of study 15. Maximum number of participants/samples/records planned (local)31. Reason for premature termination

6. Database entry template

7. Datasheet template (Entry Form 1)

8. Datasheet template (Entry Form 2)

9. Datasheet template (Entry Form 3)

10. Datasheet template (Entry Form 4)