Polaris

SOP# SITE-013.0CompanyEffective Date: DD/MMM/YYequipment, dispensing procedures and accountability records, serious adverseexperience (SAE) reporting procedures, and other study issues.4. During the initiation visit, the Study Coordinator will:a. Provide copies of outstanding regulatory documents to the Sponsor/CROrepresentative.b. Confirm that lab supplies have arrived and have been inventoried.c. Meet with the Sponsor/CRO representative to learn how the Case ReportForms (CRFs) should be completed.d. Ensure the Sponsor/CRO representative signs the Monitoring Log(Attachment A).5. During the initiation visit, the Study Coordinator and Pharmacist will discuss howthe test article will be stored (e.g., security, temperature, humidity), dispensed tosubjects, and returned to the Sponsor.a. The Pharmacist will confirm that the test article has arrived and has beeninventoried.b. The Investigator and Study Coordinator will confirm the study requirementsfor AE and SAE reporting.c. The Investigator will complete and sign the Study Responsibilities Form.d. All study staff will meet with the Sponsor/CRO representative to review theprotocol and regulatory obligations of site personnel.e. Each staff member will sign and initial the Study Site Personnel SignatureSheet.C. Periodic (Interim) Site Visit1. Prior to the Periodic (Interim) Site Visit, the Study Coordinator will:a. Prepare a list of questions related to the study.b. Ensure all original, signed informed consent documents are available.c. Ensure all CRFs are complete and signed, if appropriate.d. Ensure the appropriate documents are filed in the Regulatory DocumentsBinder.e. Ensure specific CRFs and source documents that will be reviewed areavailable on the visit date.f. Set up appointments for the Monitor to meet with the pharmacist andInvestigator.2. Prior to the Periodic (Interim) Site Visit, the Investigator will:a. Prepare a list of questions related to the study.SITE-013.0.doc© 2004 by CRC Press LLC