Study Closeout Visits Clause Samples

Study Closeout Visits. ‌ The study closeout visit will occur once all subjects have completed the study through the peri-procedure follow-up phase and all data is collected (i.e.; pathology). A study closeout visit will include all of the elements identified as part of the interim monitoring visit information. It will also include a review of data not previously audited. The study monitor will conduct a summary meeting with the study coordinator and the study investigator to discuss any discrepancies or other findings by the monitoring team. At this meeting, an attempt should be made to resolve discrepancies in the source documentation requiring the investigator’s revision. The study monitor will also review all regulatory requirements the site may have for closing this study with their REB and for the maintenance and retention period of study documentation. A closeout site visit report will be prepared, with all outstanding issues listed. The site should resolve all issues within a reasonable time after the visit. Once the study monitor verifies that all open issues are resolved, the site will be considered closed.