Polaris

SOP# MON-008.0CompanyEffective Date: DD/MMM/YYb. Protocol deviations, violations?c. Missing visits?d. Premature discontinuations?23. Has the Adverse Experiences page been checked fora. Appropriate terminology/description used?b. Onset and cessation dates?c. Duration of the event?d. Severity of the event?e. Relationship of the event to the study drug?24. Has the concomitant medications page been checked fora. Medications not allowed by protocol?b. Dosage including regimen, route?25. Have related areas of the CRF been cross-checked?a. Dates from visit-to-visitb. Concomitant medications with adverse experiencesB. On-Site Data ClarificationsDuring the site visit, the Monitor will bring discrepancies between the CRF and thesource document to the attention of the Study Coordinator or other appropriate sitepersonnel. When possible, corrections will be made before the Monitor leaves thesite. When this is not possible, the Monitor will leave a completed CRF ReviewForm, which points out the items that need resolution, with the Study Coordinator(Attachment A). The Company Monitor will not make entries in or alterations to aCRF or source document.At the next site visit, the Monitor will confirm that all issues on the CRF ReviewForm have been addressed.The Monitor will ensure that no changes to the CRF occur after the Investigator hassigned the CRF.C. Retrieval of the CRFsAfter the Monitor has verified that all of the data in the CRF are supported by sourcedocuments and that all issues on the CRF Review Form for a specific subject havebeen resolved, he/she will retrieve the original pages of the CRF.The Monitor will ensure that legible copies of all pages remain at the study site,before the original is collected. If the site’s copy is not legible, the Monitor willmake a copy of the original for the site’s files before removing it from the site.MON-008.0.doc© 2004 by CRC Press LLC