What is this service?
This is a training required by Duke University for all faculty who will hold an IND or IDE and are thus considered a sponsor or sponsor-investigator. It provides information regarding the sponsor-investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations. This training typically takes 1 hour and may be provided individually (1:1), to a small group or team, or these requirements may be fulfilled by attending our IND/IDE Best Practice Workshops. These workshops are typically held once a year. Please check our Educational Seminars page for any upcoming Best Practice Workshops.
Who can use this service?
This service may be used by Duke University sponsors or sponsor-investigators and their study teams who hold or will hold an IND or IDE.
When should I contact ORAQ about this service?
The Office of Regulatory Affairs and Quality will contact investigators following registration of an IND or IDE application with our office.
Duke University sponsors or sponsor-investigators who hold or will hold an IND or IDE may also contact ORAQ directly at ORAQ-ApplicationRegistration@duke.edu.