CREC Submission

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
Remark: Cost will be incurred for the above service. Please check with CRMO for the actual cost.

Consultation

  • Experienced clinical research specialists provide clinical research solutions on:
    • Protocol and Consent form design
    • Study start up
    • In-house training
    • Budgeting
    • Study coordination
    • Quality assurance services
Remark: Cost will be incurred for the above service. Please check with CRMO for the actual cost.

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:

  1. Trials involving research subjects who are pregnant at the time of the trials unless with prior approval
  2. 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)

Hospital Approval

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 / crmo@cuhk.edu.hk );
Ms. CHAN Mei Wah (Tel: 852-3505 4282 / crmo@cuhk.edu.hk )

For study conducted in other hospitals, you can contact the personnel listed below.

Contacts for non-PWH study:
AHNH/ TPH: Ms. Babbitt WOUN (Tel: 852-2689 2000 / wys625@ha.org.hk )
BBH: Ms. Canice CHEIU (Tel: 852-2636 0163 / bbh_enquiry@ha.org.hk )
NDH: Ms. Euracy WONG; Ms. Eva MAN (Tel: 852-2683 7908 / mmk643@ha.org.hk )
SCH: Ms. Susanna CHAN (Tel: 852-2636 7239) / chanshs@ha.org.hk )
SH: Ms. Canice CHEIU (Tel: 852-2636 7510 / sh_enquiry@ha.org.hk )

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

On-line Test (All year round)

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).

If there is any question, please contact us at 3505 4276 / crmo@cuhk.edu.hk

Site Inspection

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:

Name Dept / Specialty
Prof. Juliana CHAN CRMO
Ms. Louisa TSANG CRMO
Dr. Benny FOK CRMO
Ms. Envy LEE CREC
Ms. Jenny NG CREC
Ms. Evelyn CHAU BABE
Ms. Olivia TO Cardiology
Dr. Risa OZAKI Endocrinology
Ms. Cherry CHIU Endocrinology
Ms. Jessica CHING GI
Ms. Angel CHIM GI
Dr. Edwin HUI Oncology
Dr. Vincent LEE Paediatrics
Dr. Andrea Luk P1CTC
Ms. Jenny Yip Urology
Ms. Franco Lai Urology
Dr. Alexander Chris Vlantis Otorhinolaryngology
Dr. Herbert Loong P1CTC
Ms. Tanya Chu Clinical Pharmacology

CUHK- Clinical Trial Related Agreement

CRMO and Office of Research and Knowledge Transfer Services (ORKTS) is now working together to facilitate and enhance the clinical trial related agreement review process.

All CUHK clinical trial related agreement (new and amendment) should be firstly routed to CRMO at crmo.cta@cuhk.edu.hk. The email subject must contain all three information including Protocol no./PI name/ Sponsor. CRMO will handle and review the agreement, and then send to ORKTS if required.

For any queries, please contact CRMO at 3505 4276.

Joint CUHK-NTEC Clinical Research Management Office



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