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Local & International Regulations, Guidelines & Documents
International Guidelines & Regulations
Guidelines
ICH GCP
WHO Handbook for Good Clinical Research Practice (GCP)
Declaration of Helsinki 2013
Belmont Report

Regulations
China
中华人民共和国药品管理法
中华人民共和国药品管理法实施条例
药品注册管理办法
药物临床试验质量管理规范(修订稿)
药物临床试验伦理审查工作指导原则

United States
Title 21 Code of Federal Regulations Part 56
Title 45 Code of Federal Regulations Part 46
Title 21 Code of Federal Regulations Part 11

European Union
Directive 2001/20/EC of The European Parliament and of the Council
Directive 2005/28/EC of The European Parliament and of the Council

Local Guidelines & Regulations
Regulations
Hong Kong Government: Pharmacy and Poison Ordinance
Chapter 138A: Pharmacy and Poison Regulations
Hong Kong Government: Personal Data Privacy Ordinance
Chapter 486: Personal Data (Privacy) Ordinance
Hong Kong Government: Prevention of Bribery Ordinance
Chapter 201: Prevention of Bribery Ordinance
Hong Kong Government: Chinese Medicine Ordinance
Chapter 549: Chinese Medicine Ordinance

Guidelines
Hospital Authority
Handbook on Clinical Research Management and Compliance at Study Sites
Hospital Authority Guide on Research Ethics
Hong Kong Department of Health, Drug Office (Pharmaceutical Products)
Guidance Note on the Application for Certificate for Clinical Trial/Medicinal Test
Hong Kong Department of Health, Chinese Medicines Board (Proprietary Chinese Medicine)
Guidance Note on the Application for Certificate for Clinical Trial/Medicinal Test
Guidance Notes for Holders of the Certificate for Clinical Trial and Medicinal Test

Documents
Clinical Trials Centre, The University of Hong Kong (HKU-CTC)
HKU-CTC New Project Form- for Sponsored Clinical Studies
HKU/HA HKW Institutional Review Board (HKU/HA HKW IRB)
Submission Highlights & IRB Meeting Dates and Application Deadlines
HKU/HA HKW IRB Initial Application Form
HKU/HA HKW IRB Clinical Study Categorization Form
HKU/HA HKW IRB Protocol Amendment Application Form
HKU/HA HKW IRB Serious Adverse Events Report Form
HKU/HA HKW IRB Research Progress Report Form
HKU/HA HKW IRB Research Final Report Form
Hong Kong Department of Health, Drug Office (Pharmaceutical Products)
Certificate for Clinical Trial/Medicinal Test Application Form (Standard Scheme)
Certificate for Clinical Trial/Medicinal Test Application Form (Listed Scheme)
CIOMS Form for Suspect Adverse Reaction Report
Clinical Trial Annual Progress Report Form
Clinical Trial Final Report Form
Hong Kong Department of Health, Chinese Medicines Board (Proprietary Chinese Medicine)
Certificate for Clinical Trial/Medicinal Test Application Form
Suspect Adverse Reaction Report
Medicinal Test Report
Clinical Trial Annual Progress Report Form
Clinical Trial Final Report Form