In compliance with HA Circular No. 9/2025, effective from 1 April 2025, the Joint CUHK-NTEC CREC will implement a new charging arrangement for commercial-sponsored clinical studies regarding the management of clinical research ethics review and the legal vetting of the Clinical Trial Agreement (CTA) by the CREC and the Legal Services Department (LSD).
For Clinical Research Ethics Review Application Fee:
| Clinical Research Ethics Review | HK$16,000 per application (Note 1) |
| Annual Maintenance Fee | HK$5,000 per study site |
Note 1: For multicentre studies involving the Central IRB, the IRB of the University of Hong Kong/HA Hong Kong West Cluster (HKU/HA HKW IRB) and/or The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical REC (Joint CUHK-NTEC CREC), HK$16,000 will be charged by each of these REC/IRB for each review conducted.
A clinical research ethics review application fee of HK$16,000 and an initial annual maintenance fee of HK$5,000 per study site at the initial submission of clinical research ethics review application. Hereafter, the recurring annual maintenance fee has to be paid once a year, until submission of the final report of the study.
For the amendment submission that require another full review, the CREC reserves the right to charge the sponsor an additional fee of HK$16,000 for the review.
For HA Legal Vetting:
| Legal Vetting of CTA | HK$39,000 per sponsor-specific CTA template HK$11,000 per study site-specific CTA |
| CTA Amendment | HK$22,000 per sponsor-specific CTA template amendment HK$6,000 per study site-specific CTA amendment |
Sponsor-specific CTA template:
HA has developed a standard template of the CTA which it uses as a starting point to negotiate with sponsors. The set of terms and conditions as agreed between HA and the sponsor (sponsor-specific CTA template) will be used for all future studies to be conducted between the parties. Each sponsor will need to have its own sponsor-specific CTA template.
Under the new review mechanism, HA’s existing standard CTA template will be replaced by a new standard CTA template (New HA Standard Template). For clinical studies whose clinical research ethics review applications are submitted on or after the implementation date, sponsors, irrespective of whether they have an existing sponsor-specific CTA template with HA or not, need to start a fresh to establish a new sponsor-specific CTA template with HA based on the New HA Standard Template by paying a one-off fee of HK$39,000.
For each subsequent amendment of its own sponsor-specific CTA template, the sponsor will have to pay a legal vetting fee of HK$22,000.
Study site-specific CTA:
For each study, HA and the sponsor will enter into a CTA in respect of each study site based on its sponsor-specific CTA template (study site-specific CTA). Sponsors have to pay a legal vetting fee of HK$11,000 for each study site-specific CTA. For each subsequent amendment of the study site-specific CTA, sponsors will have to pay a legal vetting fee of HK$6,000.
For CUHK Legal Vetting:
For CUHK Legal Vetting inquiries, please contact CRMO at 3505 1032.
If you have any inquiries about the new charging arrangement, please contact CREC Office at 3505 3935.