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Pharmacy Q&A

Does Pharmacy need to be involved in my research?  

Yes, Pharmacy review all clinical trials and research studies where medicines are used. This will ensure the proposed study meets standards around the management of medicines in research e.g. they are the appropriate quality and the study meets the requirements of NHS GG&C Safe and Secure Handling of Medicines Policy.  Top  

What does Pharmacy do?  

Pharmacy services in NHS GG&C work in tandem with the Research and Development (R&D) department, reviewing all clinical trials to ensure the appropriate standards for conducting research involving medicines are met and also that the study is clinically appropriate and operationally viable. As part of the review process, the Pharmacy Clinical Trials Team will liaise with fellow staff e.g. Quality Assurance, Aseptic Services, Clinical Pharmacists and Lead Directorate Pharmacists, whereupon satisfactory completion of the review, Pharmacy approval is given and forms part of the R&D management approval process.   Where NHS GG&C are sponsor or co-sponsor for a clinical trial, Pharmacy will assist you from the very early stages of preparing your protocol, assisting you with your medicines related aspects of regulatory applications and setting up your study. Pharmacy can also help prepare the necessary documentation and assist you with IMP management processes at all stages from receipt into Pharmacy to administration to the patient.   For all other clinical trials, Pharmacy work to facilitate multi-site clinical trials as a single working stream and provide information and training to you and your study Team to ensure the trial meets the appropriate standards. We also have close links with Pharmacy clinical trial colleagues throughout Scotland via the Clinical Trial Special Interest Group (CTSIG), sharing best practices in developing our service.   A very visible part of the Pharmacy contribution to clinical trials and research is in the dispensing of medicines to patients or study subjects. Pharmacy work to Standard Operating Procedures (SOPs) and have processes in place to deal with problems such as temperature deviations or medicine defects. Medicines are generally dispensed from the local hospital pharmacy where the patient is attending for their study visits.   All pharmacy sites in NHS GG&C currently provide or have the potential to provide local services to support research.  Top  

What happens if my Clinical Trial does not come under the Clinical Trial Regulations but still involves medicines?  

R&D work closely with Pharmacy to ensure you are given the best advice.  Top  

What can I do to help obtain Pharmacy approval for my study?  

In order to help ensure your trial receives Pharmacy approval as quickly as possible, you should approach R&D and Pharmacy in the early planning stages. Pharmacy staff will often need to ask some follow-up questions and it is very helpful if researchers keep in contact with Pharmacy staff and update them on their progress and proposed start dates. Top  

What is the procedure if my study involves multiple sites within NHS GG&C?  

A system of single pharmacy review and approval is in development for multi-site clinical trials within NHS GG&C. If you are aware your study is going to run over two or more sites, you should contact the R&D-Pharmacy Team in the first instance. Top  

Who should I contact if I have a query with my Clinical Trial?  

The first point of call should be your local site Pharmacy Clinical Trials Team contact, alternatively, for a general query, you can contact the R&D-Pharmacy Team. Top  

What will it cost for Pharmacy Clinical Trial Services?  

Pharmacy work closely with R&D Finance to estimate the cost of undertaking a research project. Pharmacy Clinical Trials Services are required to charge for their involvement in all commercial clinical trials. Depending on funding, Pharmacy support service such as dispensing may be free-of-charge to researchers undertaking non-commercial research. However, real costs incurred such as manufacturing costs and the cost of additional medicines over standard care need to be met out of the study funding.  Top

Do I need to notify Pharmacy if I have received a Protocol Amendment?

  Pharmacy should receive notification of protocol amendments by R&D, however, investigators are often responsible for ensuring all relevant staff have access to the correct study protocol. It would be helpful if you verified this with the local Pharmacy site. If you need advice relating to the potential impact of your amendment on pharmacy, you should contact your site Pharmacy Clinical Trials Team or the R&D-Pharmacy Team if your clinical trial involves multiple sites or is sponsored/co-sponsored by NHS GG&C. Top  

What qualifications, skills and experience do Pharmacy have in research and clinical trials?  

The Pharmacy Clinical Trial Teams throughout NHS GG&C are composed from a mix of Pharmacists, Pharmacy Technicians and Pharmacy Support Workers. In addition to each staff group’s professional and vocational qualifications, all pharmacy clinical trial staff undergo regular Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) training. Many of our staff have significant experience of working within research and clinical trials over a number of years. Top  

How do Pharmacy Services link in with Research and Development?  

The R&D-Pharmacy Team are based in the R&D Management office at the Western Infirmary. This team forms the central hub of communication between R&D and the wider Pharmacy Clinical Trials service. Communication is also conducted directly between R&D and the Pharmacy sites as necessary. Top  

What should I do when my research study or clinical trial is nearing an end?

  It is helpful if you let Pharmacy know when you are planning to stop recruiting new patients and/or when patients have completed active treatment involving medicines. This can help Pharmacy ensure they have sufficient supplies to the end of the study in the most cost-effective way. It is standard practice for the Pharmacy file to be archived with the investigators file and arrangements will need to be made with your local Pharmacy Clinical Trials Team. Top  

I am planning a study involving medicines that will be sponsored or co-sponsored by NHS GG&C, what do I do?  

If you are planning a new clinical trial or research where medicines are used then you should contact the relevant R&D co-ordinator in the first instance. The co-ordinator will then alert the R&D-Pharmacy Team who will work with you to develop the IMP management processes for your clinical trial and liaise with the relevant site Pharmacy Teams. Top  

What is an IMP?  

IMP stands for Investigational Medicinal Product and is the special term used for medicines when they are studied as part of a clinical trial or used as part of a study protocol. Any medicines used within a clinical trial or research study must be of an appropriate quality and this is governed by UK/EU legislation. A key role of Pharmacy is to ensure the medicines used within research are always of a suitable standard for administration to study subjects.  Top  

Can Pharmacy help me with my Research Proposal?  

Yes, Pharmacy will work closely with R&D to assist you with the design and IMP related aspects of your protocol. In addition, we can provide assistance with prescription forms and accountability logs. Top  

How do I source my IMP?  

The R&D-Pharmacy Team will be able to assist you with sourcing IMPs and any other medicines that may be required. Pharmacy work very closely with the Regional Quality Assurance service (RQA) and the Pharmacy Production Unit (PPU) based at the Western Infirmary, Glasgow. PPU are licensed by the MHRA to prepare many different types of medicines for use in a clinical trial. If PPU are unable to meet the requirements for your study, then the R&D-Pharmacy Team will be able to advise/organise alternative arrangements. Top  

I am planning a study involving medicines that will be hosted within NHS GG&C, what should I do?  

If the clinical trial is to be run at only one site within NHS GG&C, you should contact the site Pharmacy as soon as possible. However, Pharmacy will not undertake a formal review for approval or begin setting up your study until notified by R&D.   If the clinical trial is to be run over two or more sites within NHS GG&C, contact the R&D-Pharmacy Team as soon as possible. Top