Clinical Research - Investigational Medicinal Product (IMP) Prescriptions

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Document Purpose

The purpose of this procedure is to ensure that prescriptions for IMP used in clinical research are created, approved, completed and authorised, as applicable, in incompliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Personnel preparing, authorising, receiving and processing the prescription promptly identify that the prescription relates to clinical research; * IMP is prescribed and dispensed in compliance with the current Protocol; * Prescriptions for IMP are completed and authorised by appropriately qualified personnel to whom the Investigator has appropriately delegated responsibility, as documented by the Signature and Delegation Log; and * Records are maintained in compliance with the SCHN Procedure - Record Keeping [DRAFT].

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