Pharmacy is an integral part of the research process and has a vital role in relation to clinical research, which is to safeguard participants, healthcare professionals and the Trust by ensuring Investigational Medicinal Products (IMP’s) are appropriate for use and are procured, handled, stored and used safely and correctly.
The pharmacy supports all types of studies: Commercial and Non-Commercial, CLRN portfolio and non-portfolio, CTIMP ( Clinical trial of an Investigational Medicinal Product) and non-CTIMPs
The Pharmacy clinical trials team is a dedicated group of Pharmacists, Technicians and Support Officers who manage pharmacy's ongoing commitment, support and development of clinical trials.
The pharmacist’s main role is to provide advice on the use of Investigational Medicinal Products (IMPs) to ensure that drug presentation, supply, storage, preparation and distribution meet current legal and professional requirements. The pharmacist will also ensure that IMPs are managed and dispensed in accordance with the protocol and maintain documentation to GCP standards for all aspects of product handling and accountability. In particular, the pharmacist will:
• Advise on regulations and guidelines on good clinical practice and good manufacturing practice.
• Advise on health and safety aspects of drug handling, dispensing and reconstitution ensuring that IMPs are appropriate for use and
are procured, handled, stored and used safely and correctly.
• Advice on protocol design, sourcing of investigational medicinal products including placebos, randomisations, label design ,relabeling , storage
preparation and drug accountability
• Monitor adherence to pharmaceutical criteria, such as previous or concurrent drug treatment.
• Provide Trust's clinical risk assessments of individual clinical trials.
• Provide pharmacy related sections for protocol, CRFs, IRAS, pharmacy manual etc.
• Review protocols for clinical investigational drug trials, as required