Ethics and Integrity
Human Ethics

• Terms of Reference - Governance Committee of HKU/HA HKW IRB
• Terms of Reference - HKU/HA HKW IRB
• Membership
• M1 - General Research Ethics Information and Definitions for Investigators and IRB Members
• IRB Standard Operating Procedures
• Standard Operating Procedure (SOP) of the Joint Scientific Committee for Phase 1 Clinical Trial
• Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials
• Lead Time of IRB Reviews for Applicants’ Reference

CRER Portal

• Please click here to access the CRER Portal

Configuration

• Client Machine Configuration Instruction (Download)
• OS: Windows
• Browsers: Internet Explorer 8 or above
• Other Software: Microsoft Silverlight 5

Enquiries (Mon – Fri 09:00 – 17:30, except Public Holidays)

• For operation: 
• IRB Office: 2255 4086 / 2255 3923 / 2255 6788
• For general: 
• Hospital Authority Head Office (Tel: 2300 8531 / E-mail: lsk990@ha.org.hk)
• For technical: 
• FlexWorkflow (Tel: 3950 6300 / E-mail: support@flexworkflow.com)

Users Manuals for Applicants and Reviewers

• Applicants (Download)
• Reviewers (Download)

Quick Guide

• For Applicant: 
• Sign Up User Account
• Fill in Application Team Management Member Form
• Fill in Application Form
• Upload Documents (Application form – Part VI)
• Handwritten Signature by PI or Department Head ("Print" function)
• Cross-cluster Study ("Clone to draft" function)
• For Reviewer: 
• Activate User Account (Coming Soon)
• Manage an  Application
• View Application Details (Coming Soon)
• Make Comments (Coming Soon)

• Sample Submission Letter
• Clinical Study Categorization Form by Principal Investigator (PI)
• 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

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

• WHO Statement on Public Disclosure of Clinical Trial Results
• Research Progress Report Form
• Research Final Report Form
• Serious Adverse Event (SAE) Report Form
• SAE Initial Report Form for Phase 1 Clinical Trials

• Clinical Research: Management and Compliance at Study Sites
• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (HA Staff) -  January 2016 version 
• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (University Staff) -  January 2016 version
• Investigator’s Code of Practice
• Hospital Authority (HA) Guide on Research Ethics (for Study Site & Research Ethics Committee)

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