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) 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

Clinical Research: Management and Compliance at Study Sites 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)

HAREC Workshop 2012 Conflicts of interest HAREC Workshop 2012 HA Governance on Clinical Research HAREC Workshop 2012 Compliance Overview HAREC Workshop 2012 Principles and Practice of ICH GCP HAREC Workshop 2012 Clinical Trial Registration HAREC Workshop 2012 Local Regulatory Compliance HAREC Workshop 2012 Form FDA1572 HAREC Workshop 2012 Informed Consent and Confidentiality Agreement HAREC Workshop 2012 Clinical Trial Insurance HAREC Workshop 2012 Indemnity HAREC Workshop 2012 Clinical Trial Agreement

HAREC Workshop 2013 Clinical Trials Concepts & Clinical Development Process HAREC Workshop 2013 Clinical Research Compliance HAREC Workshop 2013 ICH GCP: Overview & Principles HAREC Workshop 2013 ICH GCP: Insight for Investigators & Study Site Personnel HAREC Workshop 2013 Ethics Committees: ICH GCP & Beyond HAREC Workshop 2013 Informed Consent HAREC Workshop 2013 Safety Management & Reporting HAREC Workshop 2013 Case Report Forms & Source Document Management HAREC Workshop 2013 Quality Management at Study Sites HAREC Workshop 2013 Facilitation of Site Monitoring HAREC Workshop 2013 Facilitation of Audits & Inspections HAREC Workshop 2013 Personal Data Protection HAREC Workshop 2013 HA's Governance on Clinical Research HAREC Workshop 2013 List of abbreviations

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IRB Secretary :
Tel: 2255 4086
E-mail: yipcf@ha.org.hk

IRB Deputy Secretary:
Tel: 2255 3923

IRB’s address:
Room 901, Administration Block, Queen Mary Hospital

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