Polaris

SOP# SITE-011.0CompanyEffective Date: DD/MMM/YYF. On-Site Destruction of Study DrugIf the sponsor or CRO requires on-site destruction of the study drug, the StudyCoordinator should:1. Obtain a copy of the site’s SOP for study drug destruction/disposition, provide acopy to the monitor, and file a copy in the study file.2. Obtain written confirmation from the monitor identifying the specific study drugthat can be destroyed.3. Obtain appropriate paperwork concerning destruction of the drug that is requiredin the site’s SOPs (e.g., signed incineration records) and place a copy in the studyfile.4. Provide the monitor with written proof of study drug destruction from the site.5. Complete the Drug Return/Destruction Form or similar form provided by thesponsor or CRO. Provide a signed copy of the form to the monitor and retain theoriginal in the study files.G. Study Drug Record RetentionAt study completion, the Study Coordinator will file all drug records with otherregulatory documents in accordance with the record retention policy for the study. Ifdrug records are maintained by an institution’s pharmacy, they must be transferred tothe Study Coordinator for final record retention (or copied, if the pharmacy’s policy isto keep the records).IV.References21 CFR 312.44 – Termination21 CFR 312.59 – Disposition of Unused Supply of Investigational Drug21 CFR 312.60 – General Responsibilities of Investigators21 CFR 312.61 – Control of the Investigational Drug21 CFR 312.69 – Handling of Controlled SubstancesICH Guidelines for Good Clinical Practice (E6) section 4.6 – Investigational ProductsV. AttachmentsAttachment A – Investigational Product Receipt FormAttachment B – Drug Dispensing LogAttachment C – Drug Return/Destruction FormAttachment D – Study Subject Investigational Product Dispensing RecordSITE-011.0.doc© 2004 by CRC Press LLC