Quality Assurance, Education, and Audit Preparation

The Office of Research Compliance (ORC) serves as a central source for research compliance information. The ORC team conducts routine quality assurance (QA) visits. These QA visits focus on protocol adherence and regulatory compliance, and are designed to provide researchers and their study teams with immediate feedback on such matters. Additionally, these visits are an opportunity to explore best practices. The information that is generated from these visits will also be used to provide institutional leadership with a snapshot of research compliance and information about study management. Data may be used to make determinations about research resources, and educational activities, and training.

ORC accepts referrals and requests for quality assurance visits. These referrals are typically for routine quality assurance visits, focused audits, audit preparation by regulatory agencies (FDA, EMA, NIH), and occasionally related to IRB concerns.

For any FDA, EMA, or NIH site inspections, sponsor audits, or other inspection by a regulatory agency, ORC should be contacted upon notification of inspection. The ORC will provide the Investigator and clinical team with guidance and resources to assist in preparing for an audit and assuring compliance.

To request a quality assurance visit, audit preparation resources, or to review any research compliance questions, please contact [email protected].