The IRB is responsible for ensuring compliance with University policy, Federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRB is expected to provide for post- approval monitoring of research. The QA&I Review is designed to meet this requirement through a pro-active and collaborative process with investigators. The purpose of the QA&I Review is to provide information to faculty and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; to verify investigator adherence to the study design as approved by the IRB-approved protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with research regulations. The review is meant to be a collaborative process whereby the auditor assesses compliance (regulatory, policy, approved protocol, etc.) and helps the investigator resolve/correct problems and discrepancies and provides recommendations for process improvements.