Pharmacy

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The pharmacy manages investigational products for clinical trials from storing to dispensing. The service involves the consultation on packaging and labeling of investigational products, initiation meeting, inventory management, preparation and administration of investigational products, accountability, teaching, returning, monitoring and auditing. As of May 2020, the pharmacy team is supporting over 850 clinical trials.

The main pharmacy is located on the 3rd floor of The Biomedical Research Institute while the cancer clinical trials center pharmacy is located on the 2nd floor of the Seoul National University Cancer Hospital.

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Facility

  • Clinical Trials Center Main Pharmacy
    • Room Temperature Storage (20~25°C) – UPS power connected
    • Two Refrigerators – UPS power connected and alarm system (alarm sound, cell phone automatically to be called and text message to be sent.)
    • One for back up refrigerator (2~8°C) - UPS power connected and alarm system (alarm sound, automatic cell phone call and text message.)
    • Freezer (-20~-25°C)
    • Storage for returned investigational products from subjects.
    • One vertical ISO5 BSC, One horizontal ISO5 BSC
  • Cancer Clinical Trials Center Pharmacy
    • Room Temperature Storage (20~25°C) – UPS power connected
    • Three Refrigerators – UPS power connected and alarm system (alarm sound, automatic cell phone call and text message.)
    • One for back up refrigerator (2~8°C) - UPS power connected
    • Storage for returned medication from subjects.
    • Sterile preparations of chemotherapy : Two vertical ISO5 BSCs
    • Two horizontal ISO5 BSCs

Record for storage temperature and humidity

  • Room temperature
    • Highs, lows and current temperature to be recorded twice a work day.
    • Periodically conducting calibration on thermometer Refrigerator
    • Automatic temperature record: continuously recorded automatic device
    • Back up temperature recorder: hand-write highs, lows, and current temperature twice a work day.
    • Periodically conducting calibration on thermometer. -Periodically conducting calibration on Refrigerator
  • Humidity
    • Record as needed

Preparation of prescription

  • Based on study protocol, information about clinical trials is summarized and educated to all personnel.
  • Two pharmacists are required to double check preparation of investigational products before administering.

Security

  • Electronically locked Pharmacy entrance.
  • Restricted access to investigational product storage.
  • Only approved personnel are allowed to enter.

Archiving

  • Files for on-going studies are stored inside the pharmacy
  • Upon the termination of a study, files are stored until the date discussed in contract with sponsor.

Purchase and management of investigation products and supplies

  • We support to purchase other medication and supplies related to study upon a request.