A publications catalogue and an order form can be downloaded from the Publications section of the ICR website. Simply fill in the form and return it by email, fax or post.
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Practice Guidance
Royal Pharmaceutical Society, practice guidance for clinical trial services for pharmacy staff. This guidance was launched at the Royal Pharmaceutical Society conference on 19th May 2006. Thereafter the Guidance was issued to all pharmacy departments in the UK. The Guidance is essentially the standards to which all pharmacy personnel should work to when conducting clinical trials.
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SOPs and Checklists for Pharmacy Personnel
Handy-sized booklet containing a list of clinical trial activities that hospital pharmacy departments may undertake when preparing for various stages of a clinical trial. This booklet will be of interest to hospital pharmacy personnel and also to others who may liaise with them regarding clinical trial activities.
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Pharmacy Fees Survey (2005)
The Pharmacy Subcommittee devised a questionnaire which was circulated to all Institute members and all hospitals listed in the C and D directory. The aim was to obtain an overview of the current position, to assess any trends and provide guidelines on the structure and calculation of service charges. Please go to Publications for more information.
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Hints and Tips
This brief guide has been produced by the Institute's Pharmacy SIG to help researchers
to work smoothly with pharmacy departments to manage on-site clinical trial medication
as effectively as possible.
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GCP Inspections
Clinical Trials Policy - According to ICH GCP the responsibility for investigational product accountability at the trial site rests with the investigator/institution. The investigator usually delegates some or all of their responsibilities for investigational product accountability to an appropriate pharmacist, although ICH GCP would also allow the delegation to other suitably qualified staff under the supervision of the investigator, for example the research nurse.
In addition, ICH GCP requires the investigational product to be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s). There are, unfortunately, some investigators who still insist on receiving, storing and dispensing clinical trial supplies themselves rather than delegating these responsibilities to the pharmacist. However, many Trusts will have developed local policies to ensure that all medicines, including investigational products, are obtained through the pharmacy department.
