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Ethics and Regulatory
Application
New!
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Ethics Approval Tracking (EAT)

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Budgeting, Protocol/
ICF design

Ethics and Regulatory Application

  1. Support for ethics and regulatory approval application (initial, amendments, annual reports, and SUSAR)
  2. One stop solution for indemnity agreement, insurance (IST) and hospital approval
Remark: This is a chargeable item.
Dr. Benny Fok
Dr. Benny Fok
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk

Budgeting, Protocol/ ICF design

  1. Protocol/ICF design
  2. Budgeting
  3. Medical writing
Remark: This is a chargeable item.
Dr. Benny Fok
Dr. Benny Fok
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk

Ethics Approval Tracking (EAT)

  1. Additional channel for sponsors to keep track of ethics approval status
  2. Facilitate trial approval process
Ms. Amanda Man
Miss Amanda Man
Email: crmo.eat@cuhk.edu.hk

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Hospital Approval

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Clinical Trial Insurance

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Offsite Archiving

Hospital Approval

For study conducted in NTEC, you may apply through our Online Application Platform. APPLY NOW
For enquiry, please contact:
Ms. Amanda Man
Tel: (852) 3505-4284 , Email: crmo@cuhk.edu.hk

Clinical Trial Insurance

Click here for:
1. Clinical Trial Insurance APPLY NOW
2. Confirmation of Cover (Require CU Login)
Remark: This is a chargeable item.
Ms. Janiz Tsang Ms. Janiz Tsang
Ms. Janiz Tsang
Ms. Renee Wong Ms. Renee Wong
Miss Renee Wong
Tel: (852) 3505-4276
Email: crmo.insurance@cuhk.edu.hk

Offsite Archiving

  1. Engaged with international archival vendor
  2. Flexible terms of service and storage period (up to 25 years)
  3. Prospective budget can be estimated upon request
  4. 24/7 online platform allows users to manage their archival activity anywhere, anytime
Remark: This is a chargeable item.
Ms. Amanda Man
Miss Amanda Man
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk

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Clinical Trial Agreement

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Site Inspection

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Site Monitoring

Clinical Trial Agreement

  1. Single point of contact for clinical trial-related agreement
  2. Standard agreement/ amendment template is available
Ms. Kitty Ng
Ms. Kitty Ng
Tel: (852) 3505-1032
Email: crmo.cta@cuhk.edu.hk (The email subject must contain all three information including Protocol no./PI name/ Sponsor)

Site Inspection

The inspection by CRMO assesses and determines the compliance of Research Unit 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).

Ms. Louisa Tsang
Ms. Louisa Tsang
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk

Site Monitoring

►On-site monitoring throughout the study
►Customized monitoring plan based on the risk assessment
Dr. Benny Fok
Dr. Benny Fok
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk

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Central Drug Management
(Clinical Research Pharmacy)
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Drug Disposal

Central Drug Management
(Clinical Research Pharmacy)

Equipped with appropriate facility and equipment to offer coordinated IMP management in compliance with GCP and other regulations. Scope of service includes:
►Professional advice on regulatory and contractual requirements on IMP management
►Coordination of study monitoring visits/ audits or inspections by study sponsor or regulatory authorities
►Effective IMP inventory management and dispensing
►A standardized charging model
For details, click Here.

Drug Disposal

  1. Holder of Chemical Waste Producer Certificate issued by the government of HKSAR
  2. Engaged with authorized Chemical Waste Collector
  3. Traceable transferring record from storage to destruction
Remark: This is a chargeable item.
Ms. Amanda Man
Miss Amanda Man
Tel: (852) 3505-4284
Email: crmo@cuhk.edu.hk