ࡱ> }|{  bjbjBrBr X  |8.BF)^^^^^((((((($(+-(}"}}(^^B)===}F^^(=}(==r&T'^a-+'()0F)9'z.i@.''R.(>,=,$P-((F)}}}}. : Drug Labeling and Record Requirements for Investigator-Initiated Trials As the Sponsor of your Investigator-Initiated clinical trial, the is obligated to ensure that study drug is labelled according to Health Canada requirements. Per the Food and Drug Act (C.05.011), the drug needs to bear a label that sets out the following information in both official languages: (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator; (b) the name, number or identifying mark of the drug; (c) the expiration date of the drug; (d) the recommended storage conditions for the drug; (e) the lot number of the drug; (f) the name and address of the sponsor; (g) the protocol code or identification; and (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi). In addition, the following records must be maintained pertaining to the study drug: A copy of all versions of the Investigator's brochure Records respecting the shipment, receipt, position, return and destruction of the drug. In order to meet these requirements, all Investigator-Initiated clinical trials sponsored by the must have their study drug storage and labeling approved by the Research Pharmacist at AHS. 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