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Pharmacy

It is extremely important that NHS Clinical Trials Pharmacy are involved in the management of drugs (investigational medicinal product) used in drug trials.  For more information on the management of IMPs please refer to the TASC Drug Accountability Policy.

Summary of key points in arranging for storage and supply of IMPs
All CTIMPS must be registered with pharmacy.

Therefore investigators are urged to contact the Clinical Trials Pharmacist at an early stage, preferably during the development of the protocol, in order to clarify issues relating to IMP management.

Pharmacy should be provided with copies of protocols and code breaks to allow identification of trial drugs when required by a treating clinician in an emergency, unless alternative 24 hour access to IMP identity is available.

All trial drugs must be delivered to pharmacy for contents and documentation check.  Checks include IMP status, importation documents, labelling and all approvals in place before release to the trial site.  The Clinical Trials Pharmacist can then arrange for subsequent transfer to the IMP Storage & Supply Site, where relevant.

IMP Storage & Supply Sites  must be audited annually by the Pharmacy, Clinical Trials Section to ensure their ongoing suitability for this task.

A trial site intended to be used for storage and supply of IMPs not audited in the previous year must undergo a trial specific inspection as part of pre-trial monitoring.
 
CIs/PIs must understand the added responsibility for drug accountability where storage and supply of IMPs directly from trial sites is intended.

Contact:

Mrs Shona Carson
Clinical Trials Pharmacist

Pharmacy Dept
Level 5
Ninewells Hospital
Dundee
Direct: 01382 632969
Ext: 32969