About CRP

  • The Joint CUHK-NTEC Clinical Research Pharmacy (CRP) has been established under the Joint CUHK-NTEC Clinical Research Management Committee (CRMC) in April 2015 to ensure safe and high-quality management of Investigational Medicinal Product (IMP) for non-phase 1 clinical trials conducted in Prince of Wales Hospital
  • IMP involved in all clinical trials should be managed by the CRP
  • An agreement on the delegation of IMP management during clinical trial to CRP is arranged and signed by the Principal Investigator (PI) and the Pharmacist-In charge of CRP before initiation of the study
  • Principal investigators are recommended to approach CRP in the early stage of planning of a clinical trial to assess the feasibility of IMP management by CRP especially for the products requiring special storage conditions or re-constitutions.

Facility

  • CRP is located at the G/F of the Day Treatment Block and Children Wards of PWH
  • The premise is secured with burglar alarm system and restricted access control
  • The environment is air-conditioned with continuous temperature and humidity monitoring and alert system
  • CRP is equipped with pharmaceutical refrigerators and freezer, and a biological safety cabinet for aseptic reconstitution of parenteral preparations
  • A tailored computer system has been developed for efficient IMP inventory management, dispensing and finance reporting
  • Operation of CRP is supervised by pharmacists with appropriate certification on Good Clinical Practice (GCP)

Scope of Service

  • CRP offers coordinated IMP management in compliance with GCP and requirements from regulatory authorities
  • Scope of service includes
    • Professional advice on regulatory and contractual requirements on IMP management
    • Coordination of study monitoring visits/ audits or inspections by accreditation of regulatory authorities
    • Effective IMP inventory management and dispensing with accurate and confidential keeping of all documents and records

Charging Model

  • Billing on cost recovery basis for IMP management will be applied to maintain the efficient operation of the pharmacy
  • The standardized charging model comprises of three major components:
    1. start-up fee;
    2. annual management fee;
    3. dispensing/ reconstitution fee.
Joint CUHK-NTEC Clinical Research Management Office



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