Polaris

SOP# MON-011.02. On-Site DestructionCompanyEffective Date: DD/MMM/YYIf the protocol allows on-site destruction, the Monitor will obtain a copy of thepharmacy or hospital’s SOP for destruction of study products. The Monitor willensure that a copy of the SOP is in the study file and that all documents requiredby the SOP are also present (e.g., signed certification of destruction). TheMonitor will not give approval for destruction before he/she has completed thefinal accountability check and has completed the CTM Disposition Form.IV.References21 CFR 312.40 – General Requirements for Use of an Investigational Drug in a ClinicalInvestigation21 CFR 312.44 – Termination21 CFR 312.59 – Disposition of Unused Supply of Investigational DrugICH Guidelines for Good Clinical Practice (E6) section 4.6 – Investigational ProductsICH Guidelines for Good Clinical Practice (E6) section 5.12 – Information onInvestigational ProductsICH Guidelines for Good Clinical Practice (E6) section 5.14 – Supplying and HandlingInvestigational Product(s)V. AttachmentsAttachment A – Investigational Drug Shipment OrderAttachment B – CTM Disposition FormMON-011.0.doc© 2004 by CRC Press LLC