醫護人員
指南及法規 (英文為主)
指南
- ICH GCP
- WHO Handbook for Good Clinical Research Practice (GCP)
- Declaration of Helsinki 2024
- WHO Guidance For Best Practices For Clinical Trials
- Handbook on Clinical Research Management and Compliance at Study Sites
- Hospital Authority Guide on Research Ethics
- Guidance Note on the Application for Certificate for Clinical Trial/Medicinal Test
- Guidance Note on the Application for Certificate for Clinical Trial/Medicinal Test (Proprietary Chinese Medicine)
- Guidance Notes for Holders of the Certificate for Clinical Trial and Medicinal Test (Proprietary Chinese Medicine)
法規
- 藥物臨床試驗質量管理規範
- 藥物臨床試驗必備文件保存指導原則
- 藥物臨床試驗倫理審查工作指導原則
- 醫療器械臨床試驗設計指導原則
- Title 21 Code of Federal Regulations Part 56
- Title 45 Code of Federal Regulations Part 46
- Title 21 Code of Federal Regulations Part 11
- Directive 2001/20/EC of The European Parliament and of the Council
- Directive 2005/28/EC of The European Parliament and of the Council
- Hong Kong Government: Pharmacy and Poison Ordinance (Cap 138A: Pharmacy and Poison Regulations)
- Hong Kong Government: Personal Data Privacy Ordinance (Cap486: Personal Data (Privacy) Ordinance)