Pharmacy Clinical trials unit

Services Provided

• Assistance with setting up a new study at a site
• Preparation of prescription templaes, accountability logs and other documents as required
• Timely receipt, storage and confirmation of arrival of IMP and associated products
• Temperature controlled storage of IMP and associated trial products
• IMP accountability, paper based or via IVRS as required
• Dispensing to patients, in compliance with the Pharmacy Act 2007
• Aseptic preparation of IMP
• Accountability and storage of IMP returns from patients
• Destruction of IMP, as required
• Support at monitoring visits

Staff

The PCTU is staffed by two pharmacists with extensive experience in clinical trials, hospital pharmacy and industry.  

Caroline Whiriskey has a clinical background, having worked extensively in hospital pharmacy in Ireland and elsewhere. caroline.whiriskeynuigalway.ie

John Given comes from an industry background, having worked in commercial aseptics production and been QP in a number of different companies.           john.givenhse.ie

Storage

The PCTU is air conditioned and maintained between 15 and 25ºC . It is equipped with locked storage cabinets and refrigerators in which the IMP is stored. The refrigerators are maintained between 2 and 8ºC  and are serviced and recalibrated annually. Returns from trial subjects are stored separately in the unit.

Temperature Monitoring

There are two continuous temperature monitoring systems in place which monitor IMP storage conditions. The main system is calibrated at three points, and records temperatures at 10 minute intervals. Reports are downloaded monthly, printed off and filed. The second system provides alarms by text and email in the event of a temperature excursion. Both systems are services and recalibrated annually.

Aseptic Production

IMP requiring aseptic production is prepared in the Pharmacy Aseptic Services Unit, under an agreement between GUH and the CRFG. This unit comprises two negative pressure and one positive pressure isolator, located in a clean room, with an outer preparation room and external rooms for worksheet preparation and final release of products.

Location

The Pharmacy Clinical Trials Unit (PCTU) is located in University Hospital Galway, under the umbrella of the hospital pharmacy department. Investigational Medicinal Products (IMP) and associated supplies are stored in a dedicated unit on the second floor of the outpatients building.  

 

• Disclaimer
• Privacy
• Copyright
• Accessibility