PERIODIC MONITORING VISITS Sample Clauses

PERIODIC MONITORING VISITS. Monitoring visits will be conducted in accordance with Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, August 2013, and the study-specific monitoring plan. The monitor should visit each site at an appropriate frequency to ensure the following: • Facilities continue to be adequate and acceptable. • The protocol is being properly followed. • The IRB or EC has approved or been notified of any protocol changes. • Accurate, complete, and current records are being maintained, and the information recorded and submitted to the Sponsor is representative of the subject’s records and other supporting documentation. • Accurate, complete, and timely adverse event reports are being submitted to the Sponsor. • Informed consent has been obtained. • The reason for a subject’s withdrawal from the study has been documented. • Reports are being submitted to the IRB or EC and Sponsor. • The appropriate staff is conducting study activities. The investigator or designee must, upon request, provide to the Sponsor or FDA investigator the necessary study records for a thorough review of the study’s progress. These records include, but are not limited to, study-specific data forms and original documents and records such as clinic charts, subject informed consent forms, and treatment reports. All study-specific data forms and other documentation related to the study will be reviewed upon receipt, and the site will be promptly notified of any deficiencies.