Polaris

SOP# MON-007.0CompanyEffective Date: DD/MMM/YY3. Facilities and Staff. To ensure the continued acceptability of the facilities andstaff, the Monitor will note if there have been any changes in space or equipmentor accreditation of the clinical laboratory facilities and study site personnel. Ifnecessary, the Monitor will update pertinent documents (e.g., FDA Form 1572)or may add other documents to the file (e.g., a new Study Coordinator’s CV).4. Drug Storage and Accountability. To ensure maintenance of accurate records ofdrug receipt and disposition and to ensure secure storage and adequate suppliesof investigational drug, the Monitor will:a. Perform a routine check of all records dealing with the shipment, receipt, anddispensing of all test articles.b. Cross-check shipment records with records of receipt (i.e., contents of theshipment, corresponding identification numbers, and dates).c. Perform a routine check of the drug inventory to ensure that an adequatesupply of test article is maintained, storage conditions are being met, anddrug expiration dates are noted.d. Check the accuracy of dispensing and return records for test articles betweenthe Investigator and the individual study subject (i.e., subject identificationnumbers, lot numbers, quantity dispensed and returned, dates dispensed andreturned, label numbers, and balance on hand).5. Informed Consent. To verify proper completion of the Informed Consent Formby each subject prior to study entry, the Monitor will:a. Ensure that a signed copy of the informed consent document is present foreach subject enrolled in the study and each screen failure;b. Compare the date of initiation of therapy or prestudy testing with the date thesubject signed the Informed Consent Form to ensure the subject consented toparticipate in the study before actual enrollment; andc. Document in the Periodic Visit trip report the patient numbers of theInformed Consent Forms that were reviewed at each visit and anyirregularities found. Include a description of the irregularities in the followupletter to the Investigator.At a Periodic Site Visit, if a Monitor discovers that an outdated version of theconsent form was used for a subject whose participation in the trial has not beencompleted, he/she will instruct the Study Coordinator to contact the subject andhave the subject sign the correct version. When signing and dating the correctversion, the subject should use the actual date (i.e., do not back-date the consentform or use the same date as on the first, incorrect version). The Monitor willinstruct the Study Coordinator to maintain both signed versions of the consent inthe files. An explanatory memo to the file is recommended so that future auditorswill understand why two signed informed consent documents for the same subjectare present in the file. If the Study Coordinator is unable to contact the subject,the explanatory memo should also document the dates and methods by which theattempts to reach the subject were made.MON-007.0.doc© 2004 by CRC Press LLC