The University of Hong Kong Clinical Trials Centre
New Project Form
- for Sponsored Clinical Studies
A. Contact Organization
(Sponsor or CRO)
Organization
Name
Address
Contact Person
Name
Tel
Title
Fax
Email
Retype Email
Remark: To enter multiple email addresses, please enter each one followed by a semicolon without a space, i.e., abc@abc.com;def@def.com
B. Sponsor
(If different from above)
Name
Address
C. Study Information
*The following information is required for submission to IRB(s). Please ensure that correct and accurate information is provided.
Study Nature
Study Title
Protocol No.
Disease Area
International / Local Study
[Select]
International
Local (HK Only)
Study Phase / Type
[Select]
I (First-to-Human)
I
II
III
IV
Observational / Registry
Early Access / Compassionate Program
Epidemiology Study
Others
Not Applicable
Planned Timeline
Study Initiation Date
Recruitment Period
Study Closure Date
Final Report Date
Study Articles
(Investigational Articles & Comparators)
Add
Compound / Generic Name
Type
Route of Administration
Dosage
Duration of Treatment / Use
Licenced in HK
GMP Production
Delete
[Select]
Chemical Drug
Biological Drug
Vaccine
Traditional / Herbal Medicine
Nutritional Supplement
Device
Others
[Select]
Oral
Parenteral
Topical
Suppository
Inhalation
Implant
Others
[Select]
Yes
No
[Select]
Yes
No
Subject Safety,Ethics & Regulatory
Independent Data Monitoring Committee
[Select]
Yes
No
Phase I Data Available
[Select]
Yes
No
Biological Samples / Data Reserved for Future Use
[Select]
Yes
No
Study Participation Card for Subjects
[Select]
Yes
No
Payment by Subjects for Study Participation
[Select]
Yes
No
Details
Free Supply of Study Articles to Subjects After Study
[Select]
Yes
No
Details
Anticipated Benefits to Subjects
[Select]
Yes
No
Details
Will the Study Data Collected at QMH Support New Drug Application (NDA) to NMPA
[Select]
Yes
No
Details
Is the IMP an Advanced Therapy Product (ATP) under Pharmacy & Poisons Ordinance (Cap 138)
[Select]
Yes
No
Details
Sample Size
Entire Study (Global)
Local (Hong Kong)
D. Local Study Site Information
Add
Planned Study Sites in Hong Kong
Principal Investigator Name
Principal Investigator Department
IRB Application
Planned No. of Subjects
Payment to Subjects
CTC Services Needed
Delete
[Select]
Not Yet Submitted
Under Review
Approved
Disapproved
[Select]
No
Yes
E. Study Documents Attached
(Soft copies attached to this form)
Study Protocol
Informed Consent Form
English
Chinese
F. Services Requested
CTC Services
Hospital Services
Research Pharmacy / Drug Disposal
Study Site Document Archiving
Regulatory Affairs
Support from HKU Phase 1 Centre
Others (Specify):
Hospital Laboratory Services
Imaging Services
Hospital Pharmacy Services
Others (Specify):
Submit
