Research Ethics

Clinical Trial Registration

1.	Registration in a publicly accessible trials registry is a condition of consideration for publication in the International Committee of Medical Journal Editors (ICMJE) member journals. "Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, the ICMJE member journals will require registration by September 13, 2005, before considering the trial for publication." See ICMJE statement in NEJM 2004 Sept; 351(12):1250-1 or latest update and clarification from ICMJE.
2.	Ottawa statement: Principles for international registration of protocol information and results. See BMJ 2005 Apr; 330:956-8.
3.	Data Element Definitions required by ClinicalTrials.gov - details on the information that is entered via the PRS

Hospital Authority Central Register
of Clinical Research

This database provides an overview of clinical research activities in all HA hospitals. The current dataset contains:

Basic Information
1. Application reference number.
2. Name of Research Ethics Committee.
3. Study title.

Principal Investigator (PI)
4. Title, surname, other name and primary institution of PI.
5. Is the PI a HA staff?

Study SiteMembers
6. Is the study a single or multi centre trial?
7. Specialty involved.
8. Primary study site.
9. Is the study an international study?

Milestones
10. Proposed study start date.
11. Initial intended completion date.
12. Final report receipt date.

Multi-centre Proposals
13. Is the research a cross-cluster study with approval by another REC?
14. Reference number of the protocol approved by another REC (if applicable).

Study Subjects
15. Maximum number of participants/samples/records planned (local).

Study Design and Methodology
16. Study design.

Product
17. Investigational article.
18. Is the test drug licensed in HK?

Potential Hazards
19. Does the study involve an additional invasive procedure?

Data Monitoring
20. Is there an independent data monitoring committee?

Source of Funding
21. Primary source.

Financial Costs and Payment to Subjects
22. Any fee income to hospital?
23. The alternative source of income (if applicable).

Indemnity
24. Is there an external/indemnity insurance provided?

Study Phase
25. Phase of trial.
26. Protocol submission date.

REC Review Decision
27. Date of REC review decision.
28. REC review decision.
29. Reason for REC disapproval (if applicable).

Premature Termination
30. Date of premature termination of study.
31. Reason of premature termination.

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Clinical Effectiveness Section,
Clinical Effectiveness & Technology Management Department,
Quality & Safety Division,
Hospital Authority Head Office

Last update: 3 August 2007