Polaris

SOP# MON-006.0CompanyEffective Date: DD/MMM/YYII.III.ScopeThis SOP will apply to all Study Initiation Visits conducted by Company.ProceduresA. GeneralStudy Initiation Visits may be conducted only by individuals at the level ofMonitor/Clinical Research Associate (CRA) or above. If the Monitor for the studysite has been selected, it is recommended that he/she attend the Study Initiation Visit.The Monitor should ask to have all study personnel present at the Study Initiationmeeting. At the conclusion of the visit, the Monitor must be satisfied that all staffmembers participating in the study are sufficiently informed to competently fulfilltheir responsibilities. All unresolved issues should be discussed with the ProjectManager and then readdressed with the Investigator.A Study Initiation Visit will be conducted after a site has been selected to participatein a trial but before subject screening and enrollment begins. This visit allows allparticipants (including the pharmacist, radiologist, and other personnel who did notattend the investigator’s meeting) to receive detailed instruction concerning their rolein the study.B. Prior to the Study Initiation VisitPrior to the Study Initiation Visit, the Monitor will:1. Determine which regulatory documents are outstanding and should be retrieved atthe visit.2. Schedule the visit with Investigator(s) and study personnel.3. Send a confirmation letter outlining the purpose of the visit and items fordiscussion and listing outstanding regulatory documents to be retrieved.4. Gather study materials to carry/ship to the site, such as a sample Case ReportForm, regulatory documents binder, Study Procedures manual, etc.5. Arrange for drug shipment to site.6. Review budget and payment schedule.C. Conducting the Study Initiation VisitDuring the Study Initiation Visit, the Monitor will:1. Meet with the Investigator to discuss federal requirements specified in FDA Form1572, including:a. Obtaining and documenting informed consent;b. IRB approval and progress reports, including amendments and SAEs;c. Protocol adherence;d. Drug accountability;MON-006.0.doc© 2004 by CRC Press LLC