• Commencement of Operation - Open Circular by Chairman, HKU/HA HKW IRB
• Terms of Reference
• Membership
• M1 - General Research Ethics Information and Definitions for Investigators and IRB Members
• IRB Standard Operating Procedures
• Submission Highlights & IRB Meeting Dates & Application Deadlines
  

• Sample Submission Letter
• Clinical Research Ethics Review Application Form ( Note to applicants : Please ensure the completeness of the form by checking for any missing fields at the end of the form )
• Expedited Review Form for Multi-center Trial approved by another Cluster REC
• Protocol amendment form
• Declaration of Support from Other Departments/Services of HKW Cluster Hospitals
• Investigator's conflict of interest declaration form
• Guideline Notes - for Preparation of A Study Protocol
• Guideline Notes - for Preparation of Subject Information Sheet and Informed Consent Form
• Guideline Notes - for Preparation of Principal Investigator's Short CV
• Research progress report form
• Research final report form
• Serious adverse event (SAE) report form

Application for Clinical Trial Certificate
Under the Pharmacy & Poisons Regulations (36B), before the commencement of a clinical trial for drugs or medicinal test, a clinical trial certificate must be obtained. The procedure for the application can be found in the following website: http://www.psdh.gov.hk/eps/webpage.jsp

• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (HA Staff)
• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (University Staff)
• Investigator's Code of Practice in Undertaking Clinical Research
• Hospital Authority (HA) Guide on Research Ethics ( for Study Site & Research Ethics Committee )
  

Declaration of Helsinki (2008)

HKU Clinical Trial Register

• Hong Kong West Cluster (accessible only via HKWC's intranet)
• Queen Mary Hospital (accessible only via QMH's intranet)