For Experienced Clinical Research Staffand IRB Members
Basic GCP Course
Self learning
GCP examination
Accreditation
Course fee
For Less Experienced Clinical Research Staff
Study Site Management
Lectures
Practices
Master of Public Health Module
Examination
Course fee
Important Guidelines/Reports/Standard Operating Procedures
The Nuremberg Code
(X)
Belmont Report
Declaration of Helsinki
(X)
Statement of Investigator
The International ICH GCP Guidelines: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
E2A: Clinical Safety Data Management
E6: Good Clinical Practice: Consolidated Guideline
(X)
E8: General Considerations for Clinical Trials
E9: Statistical Principles for Clinical Trials
E10: Choice of Control Group and Related Issues in Clinical Trials
E11: Clinical Investigation of Medicinal Products in the Pediatric Population
Standard Operating Procedures (SOPs)
Study Site SOPs
Local IRB SOP
(X) – highly recommended
Other sites administered by Clinical Trials Centre (CTC)
CTC Home Page
HK Clinical Trials Register – ongoing and completed trials
HK Site Management Organisation – ClinCluster
Modified on 26 September, 2011.
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