Polaris

SOP# SITE-013.0CompanyEffective Date: DD/MMM/YYb. Review data collected and sign CRFs for completed subjects.3. During the Periodic (Interim) Site Visit, the Study Coordinator will:a. Interact with the Monitor to validate the data in the CRFs and answerquestions about the data or regulatory documents.b. Follow-up on outstanding data clarifications.c. Attend a meeting with the Monitor and Investigator to learn about theMonitor’s findings.d. Ensure that the Monitor signs the Monitoring Log.D. Close-Out Visits1. Prior to the Close-Out 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 and data clarification forms are complete and signed.d. Ensure the appropriate documents are filed in the Regulatory DocumentsBinder.e. Ensure all source documents are organized for easy retrieval during futureaudits.f. Ensure all drug accountability records are complete and that unused testarticles have been returned to the Sponsor or destroyed.g. Set up appointments for the Monitor to meet with the Investigator and studystaff to discuss study issues and concerns.h. Ensure that the Monitor signs the Monitoring Log.2. Prior to the Close-Out Visit, the Investigator will:a. Prepare a list of questions related to the study.b. Review data collected and sign CRFs for completed subjects.3. During the Close-out Visit, the Study Coordinator will:a. Interact with the Monitor to validate the data in the CRFs and answerquestions about the data or regulatory documents.b. Follow-up on outstanding data clarifications.c. Attend a meeting with the Monitor, Investigator, and other study staff todiscuss study issues and concerns.d. Ensure that the Monitor signs the Monitoring Log.SITE-013.0.doc© 2004 by CRC Press LLC