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Medicines are subject to human testing prior to licensing, and established products may be investigated for new indications. It is important for the safety of the patient that clinical trials involving new medicines, or medicines under evaluation for new indications, are managed under strict controls.
4.1	All clinical investigators at the planning stage must, through the Clinical Trials Pharmacist or their Senior Clinical Pharmacist, make appropriate arrangements, including the management of the trial supplies.
4.2	All clinical investigators, before beginning studies, either on human volunteers or patients, shall obtain the approval of the Tayside Committee on Medical Research Ethics and register with the Research and Development Office.
4.3	Since products under investigation may be unlicensed and are generally unfamiliar to the staff handling them, extra precautions need to be taken with these products to ensure safety and security in their use.
4.4	The pharmacy department shall hold a copy of all trial protocols involving patients and where appropriate, code-breaks for studies.
4.5	Clinical trial medicines will normally be dispensed by the pharmacy department. Separate stocks of medicines must not be held on the wards or in clinics unless agreed with the Clinical Trials Pharmacist.
4.6	Prescribing and administration of clinical trial medicines shall be in accordance with procedures set out elsewhere in this manual.
4.7	Records shall be kept of receipt, dispensing, issue, administration, return and disposal of all medicines. The identities of all those involved shall also be recorded.