Are CVs of pharmacists current and ☐ ☐ ☐ ☐ on file? Are licenses of pharmacists current ☐ ☐ ☐ ☐ and on file? Are decoding procedures for blinded ☐ ☐ ☐ ☐ trials available? Is the Master Randomization list ☐ ☐ ☐ ☐ available? ☐ Not Product Storage Yes No N/A Reviewed Is the investigational product stored in a secure manner (e.g. access ☐ ☐ ☐ ☐ restricted to authorized individuals)? Is the investigational product being stored in a manner consistent with the product storage requirements ☐ ☐ ☐ ☐ (e.g. proper temperature, sterile conditions, separately by protocol) If applicable, is a temperature log ☐ ☐ ☐ ☐ maintained? If applicable, are there notification procedures in place if a product ☐ ☐ ☐ ☐ storage area falls outside of the storage requirements? ☐ Not Product Inventory Yes No N/A Notes Reviewed Is inventory conducted on ☐ ☐ ☐ ☐ regular/routine basis (i.e. monthly)? Did the physical inventory count ☐ ☐ ☐ ☐ match the accountability record? TIP: If the physical inventory totals do not match the accountability record, is there documentation to explain why the numbers do not match? Are the investigational products appropriately packaged and clearly ☐ ☐ ☐ ☐ coded and/or labeled? Is the expiration date tracked, if ☐ ☐ ☐ ☐ applicable? ☐ Not Product Accountability Records Yes No N/A Notes Reviewed TIP: Subject specific drug dispensation and accountability questions are included on the Tool: Subject Record Review.
Are CVs of pharmacists current and on file? ☐ ☐ ☐ ☐ Are licenses of pharmacists current and on file? ☐ ☐ ☐ ☐ Are decoding procedures for blinded trials available? ☐ ☐ ☐ ☐ Is the Master Randomization list available? ☐ ☐ ☐ ☐ Product Storage Yes No N/A ☐ Not Reviewed Is the investigational product stored in a secure manner (e.g. access restricted to authorized individuals)? ☐ ☐ ☐ ☐ Is the investigational product being stored in a manner consistent with the product storage requirements (e.g. proper temperature, sterile conditions, separately by protocol) ☐ ☐ ☐ ☐ If applicable, is a temperature log maintained? ☐ ☐ ☐ ☐ If applicable, are there notification procedures in place if a product storage area falls outside of the storage requirements? ☐ ☐ ☐ ☐ Product Inventory Yes No N/A ☐ Not Reviewed Notes Is inventory conducted on regular/routine basis (i.e. monthly)? ☐ ☐ ☐ ☐ Did the physical inventory count match the accountability record? ☐ ☐ ☐ ☐ TIP: If the physical inventory totals do not match the accountability record, is there documentation to explain why the numbers do not match? Are the investigational products appropriately packaged and clearly coded and/or labeled? ☐ ☐ ☐ ☐ Is the expiration date tracked, if applicable? ☐ ☐ ☐ ☐ Product Accountability Records Yes No N/A ☐ Not Reviewed Notes TIP: Subject specific drug dispensation and accountability questions are included on the Tool: Subject Record Review.
Self-AuditToolInvestigationalProductReview_2018.06.01.docx