To apply clinical research ethics approval, we provide a one stop application service for those who are interested.
- Providing administrative support for initial submission, amendments, and annual progress reports at a minimal cost
- Providing biweekly submission services for SUSAR
- Reducing administrative workload and hassle from research teams
- One stop solution for ethics approval, indemnity agreement, clinical trial insurance (for Investigator-sponsored trial only) and hospital approval
- Experienced clinical research specialists provide clinical research solutions on:
- Protocol and Consent form design
- Study start up
- In-house training
- Study coordination
- Quality assurance services
External Archive Service
CRMO has arranged an external archiving service provided by the global company for our investigators at a reasonable price. Prospective budget can be estimated upon request. Please contact CRMO for more information.
Clinical Trial Insurance
Since 2007, Clinical Trial Insurance has been introduced to offer protection to researchers who are involved in clinical trials recruiting human subjects. To offer broader coverage in clinical trials, a new insurance company (Newline Asia Services Pte. Ltd.) has been chosen with effect from 1 July 2015.
Investigators should assess the risk level of their trials and decide whether or not to join the scheme. Applications, including application form, updated CREC ethics approval letter and protocol, should be submitted to CRMO for follow-up.
*Please note the policy exclude:
- Trials involving research subjects who are pregnant at the time of the trials unless with prior approval
- Trials involving research subjects who are under age of 3 years at the time of the trials unless with prior approval
PIs are suggested to specify in the study protocol whether pregnant women and child under age of 3 years are involved
Any enquiries (e.g. Terms and Conditions), please contact Ms. Janiz TSANG (Tel. 852-3505 4276)
According to the policy established by Joint CUHK- NTEC Clinical Research Management Committee (CRMC) (Mar 2011) and CRMO-SOP-018 developed by CRMO (2014), Hospital Approval is required on all NTEC clinical trials before commencing the study if the trials involve
- NTEC staff, and/ or
- NTEC patients
Details can be acquired from slides.
For study conducted in PWH, please submit the Application Form ( WORD / PDF ) and required documents to CRMO.
Contacts for PWH study
Ms. Florence CHEUNG (Tel: 852-3505 4284 / firstname.lastname@example.org );
For study conducted in other hospitals, you can contact the personnel listed below.
Contacts for non-PWH study:
AHNH/ TPH: Mr. Kenneth CHEUNG (Tel: 852-2689 3639 / email@example.com
BBH/SCH/SH: Ms. Winnie WONG Tel: 852-3919 7746 / firstname.lastname@example.org
NDH: Ms. Euracy WONG; Ms. Eva MAN (Tel: 852-2683 7908 / email@example.com
Arrangement of HA-CTA (PWH only)
- Contact person of HA-CTA vetting. Your HA-CTA will be forwarded to Legal Service of HA head-office for vetting
- Contact us for HA-CTA template
Participation & Issue of certificate:
- CRMO website registered member:
- You may access directly using your password
- Upon completion of the test (and meeting the passing mark), we will issue and email a certificate to you immediately. This certificate will also be uploaded to your training record.
- Non-CRMO website registered member:
- Please kindly register through HERE. A temporary login password for the online test will be sent to you via email.
- Upon completion of the test (and meeting the passing mark), we will issue and email a certificate to you immediately.
Take the test (make sure you have the login password).
Remarks: This GCP online test is not an internally recognized certified test (not a TransCelerate BioPharma certified test). This certificate may serve as an interim GCP qualification only until you have a certificate of TransCelerate BioPharma certified course.
If there is any question, please contact us at 3505 4284 / firstname.lastname@example.org
The inspection by CRMO is a regular, independent and systematic review of Clinical Research Units to assess and determine their compliance to the study protocol, CUHK-NTEC CRMO SOP, ICH-GCP and other relevant regulatory requirements.
For details, please refer to SOP for Inspection of Clinical Research Unit (CRMO-SOP-019). Clinical Research Inspection Team:
||Dept / Specialty
|Prof. Juliana CHAN
|Ms. Louisa TSANG
|Dr. Benny FOK
|Ms. Envy LEE
|Ms. Jenny NG
|Ms. Evelyn CHAU
|Ms. Olivia TO
|Dr. Risa OZAKI
|Ms. Cherry CHIU
|Ms. Jessica CHING
||SCM / GI
|Ms. Angel CHIM
|Dr. Edwin HUI
|Dr. Vincent LEE
|Dr. Andrea Luk
|Ms. Jenny Yip
|Ms. Franco Lai
|Dr. Alexander Chris Vlantis
|Dr. Herbert Loong
|Ms. Tanya Chu
CUHK- Clinical Trial Related Agreement
In order to further enhance the clinical trial related agreements review process, with effective on 1 Aug 2018, all clinical trial related agreements (initial and amendment) will be reviewed and vetted by CRMO.
All CUHK clinical trial related agreement (initial and amendment) should be routed to CRMO at email@example.com. The email subject must contain all three information including Protocol no./PI name/ Sponsor. CRMO will handle and review the agreement.
For any queries, please contact CRMO at 3505 1032.