Investigator-initiated clinical studies (IISs) play an important role in translating medical discoveries and hypotheses into clinical practice and bringing important value to advancement of human healthcare. To encourage and facilitate more high impact IISs, HKUMed has recently delegated the Clinical Trials Centre (CTC) and the Biostatistics and Clinical Research Methodology Unit (BCMU) to establish an “IIS Facilitation Scheme”, through which a range of supports and services will be offered to clinical investigators by stages.
The first initiative under this Scheme is a comprehensive training programme which comprises 4 courses.
|Course 1: Study Design & Sample Size Calculations|
|1.1 Big Data Research|
|1.2 Clinical Trial Design|
|1.3 Sample Size Calculations|
|Course 2: Data Management & Practice of Electronic Data Capture|
|2.1 GCP in Clinical Data Management|
|2.2 Building eCRF in REDCap|
|2.3 Advanced Features in REDCap|
|2.4 eCRF/Database Standardization|
|Course 3: Ethics, Regulatory & Legal Compliance|
|3.1 Types of IISs and Investigators’ Roles|
|3.2 Compliance with IRB Requirements|
|3.3 Compliance with Local Regulatory Requirements|
|3.4 Compliance with China Regulatory Requirements|
|3.5 Registration on Public Clinical Trials Registries|
|Course 4: Good Clinical Practice (R2)|
|4.1 Clinical Research Compliance|
|4.2 ICH GCP: Overview & Principles|
|4.3 ICH GCP: Insight for Investigators & Study Site Personnel|
|4.4 Informed Consent: Principles & Practical Considerations|
|4.5 Study Document Management|
|4.6 Investigational Product Management|
|4.7 Safety Management & Reporting|
|4.8 Quality Management at Study Sites|
Over 300 researchers have received our training so far. Courses will be launched in the coming months. Please pay attention to announcements on HKU-CTC’s website or by HKU emails. Stay tuned!
Other courses will be launched in the coming months. Please pay attention to announcements on HKU-CTC’s website or by HKU emails. Stay tuned!