Pharmacy Clinical Trials Service at TUH Service Opening Hours (Pharmacy Clinical Trials and Aseptic Unit): Monday – Friday (excluding bank holidays) 8am – 4pm Services provided: The Pharmacy Clinical Trials service is based within TUH Pharmacy Department. Our Pharmacy Clinical Trials team work closely with colleagues within the Pharmacy Aseptic Unit to ensure the following services are provided in a competent manner in compliance with ICH-GCP and local regulatory requirements; - Set up of new studies at site
- Preparation of in-house prescription forms, drug accountability logs and other documents as required
- Drug storage within a secure, environmentally-controlled area
- 24-hour temperature control and monitoring of storage area with daily maintenance of temperature logs
- Provision of information to study participants, medical and nursing staff
- Accountability of IMP (paper-based and IXRS, as required)
- Stock management including timely receipt, storage and dispensing of IMP and supportive medicines.
- Aseptic preparation of IMP where required
- Destruction of IMP, as required
- Facilitating and support at monitoring visits
- Procedures associated with trial completion
- Archiving of pharmacy trial documentation for a minimum of 15 years
About our Pharmacy Aseptic Unit The aseptic unit is located in a clean room environment which must adhere to Good Manufacturing Practice standards. This unit is run by a dedicated team of highly skilled pharmacists and technicians. All chemotherapy, clinical trials for cancer patients and high cost/high risk products for gastroenterology/rheumatology departments are prepared under validated sterile conditions. In order to maintain these conditions, the aseptic unit is constantly audited against various standards. Closed system transfer devices (CSTD) are routinely used by our Aseptic Unit for the preparation of medications to maximise sterility of products and reduce occupational exposure. The CSTD used by the TUH Pharmacy Department is Q-FLO™, Manufacturer: BTC. Where an Investigational Medicinal Product is not thought to be compatible with preparation using a CSTD, please contact the pharmacy clinical trials team to discuss further options available to help facilitate the study. Contact details: Contact us by phone at 01-414 3869 or by email on Pharmacy.clinicaltrials@tuh.ie Riona Tumelty, Senior Pharmacist - Riona.Tumelty@tuh.ie Sharon Curran-Rae, Senior Pharmaceutical Technician - Sharon.Curran@tuh.ie | 
