The answer is close out visit which
• Ensure regulatory documents on site match in house file
• Endure all CRF are complete and submitted to sponsor
• All queries are addressed
• AE/SAE follow up are addressed
• All signed informed consent forms are files
• Ensure study drug logs are complete and all study drug returned to sponsor per instructions
• Ensure investigator brochure and study materials are filed together
• Review long term storage and final report is completed and submitted to IRB and sponsor
