Investigator agreement

An agreement signed by the participating investigator to provide the sponsor of an investigational device trial with the investigator’s qualifications, financial disclosure information, and assurance to conduct the clinical investigation of an investigational device in accordance with the investigator agreement, the investigational plan, the Investigational Device Exemption (IDE) and other applicable Food and Drug Administration (FDA) regulations, and conditions of approval imposed by the reviewing Institutional Review Board (IRB) or FDA. FDA: 21 CFR 812.43(c)