Polaris

SOP# MON-011.0CompanyEffective Date: DD/MMM/YYIII.ProceduresThis SOP will refer to “clinical trial material (CTM).” This term will include all drugs,devices, placebos, and active comparators used in the trial.A. Prior to ShipmentAt the Site Evaluation or Study Initiation Visit, the Monitor will record the name ofthe pharmacist who will be responsible for the study and the address the CTM will beshipped to.The Monitor will ensure that all Company-required study initiation documents arepresent before clinical trial materials are shipped to the study site. When thedocumentation is complete, the Monitor will request that the clinical trial material beshipped to the site and should learn what date the shipment is expected to arrive.The Monitor should call the Pharmacist at the site and alert him/her concerning theexpected arrival. The Monitor will explain to the Pharmacist that the CTM will beaccompanied by the Investigational Drug Shipment Order (Attachment A) or othersimilar form used by Company or the sponsor and that the Pharmacist should:1. Confirm the shipment contents against the document;2. Sign the document;3. Fax a copy of the signed document to the Monitor; and4. Place the original, signed document in the study or pharmacy files.B. Soon after ShipmentAt the first visit to the site after the CTM has been shipped, the Monitor shouldconfirm that the CTM has arrived intact, that the expected amounts were included inthe shipment, and that the CTM is being stored correctly.C. During Site VisitsOn a regular basis, during Periodic Site Visits, the Monitor will:1. Review the Investigator/Pharmacist’s CTM inventory record;2. Perform a physical count of the CTM;3. Check CTM storage conditions;4. Verify each subject’s compliance with the dosing requirements;5. Confirm that the CTM labels are being handled as specified in the protocol;6. Request additional CTM shipments, if needed;7. Document monitoring of CTM records in the site visit report; and8. Identify the specific amounts needed for:a. Each dose form of active drug,b. Placebos, andc. Comparative actives.MON-011.0.doc© 2004 by CRC Press LLC