Training Program Title
IND and IDE Sponsor and Investigator Training
CTSA Hub Administered
Office of Regulatory Affairs and Quality
Training Program Description
This training provides information regarding the sponsor and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations.
There are two separate training modules that each focus on the requirements for the specific regulatory application that the sponsor or sponsor-investigator holds. Sponsors who hold an IND (for drugs and biologics) can complete the training module entitled “IND Sponsor and Investigator Responsibilities." Sponsors who hold an IDE (for medical devices) can complete the training module entitled “IDE Sponsor and Investigator Responsibilities.”
Duke University's Office of Regulatory Affairs and Quality created versions of the training modules that are available to academic institutions outside of Duke at no cost. They are available in a format that is compatible with most Learning Management Systems (LMS) to give you the ability to track registration and completion of training. They are also available in an HTML format for web viewing and as PDFs. Please visit our website to learn more and to request the modules.
Biologic, Device, Drug, Investigational device, FDA (Food and Drug Administration), IDE (Investigational Device Exemption), IND (Investigational New Drug or Device), Sponsor, Adverse event, PI oversight, Regulatory guidelines, Reporting requirements, Safety reporting
Digital Commons Disciplines
Cost to Access
Medicines Development and Regulation
The learning objective is to understand IND and IDE regulatory responsibilities for sponsors and investigators.
Principal Investigators; Clinical Research Professionals (other than PI)