What is this training?
This is a training module 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 and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations. This training takes approximately 1 hour and is completed online in Duke University’s Learning Management System (LMS). It consists of video modules followed by a brief quiz.
There are two separate training modules within the LMS 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) will complete the training module entitled “Duke University Training Modules on IND Sponsor and Investigator Responsibilities”. Sponsors who hold an IDE (for medical devices) will complete the training module entitled “Duke University Training Modules on IDE Sponsor and Investigator Responsibilities.”
Who should complete this training?
Completion of the IND or IDE training modules is required for Duke University sponsors or sponsor-investigators who hold or will hold an IND or IDE, respectively. The training modules are also available to anyone else at Duke University who is interested in learning about the roles and responsibilities of IND or IDE sponsors and investigators.
How do I register for this training?
The Office of Regulatory Affairs and Quality will register regulatory sponsors for the appropriate training module in the LMS following registration of an IND or IDE application with our office. You will receive an e-mail from the LMS notifying you that you are registered for the course. A link to access the training module in LMS will be included in the e-mail.
If you are not a regulatory sponsor but are interested in completing this training, you can register for the modules by logging into the LMS using your Duke University NetID and password. After logging into the LMS, you can locate the IND or IDE training module by typing the name of the module into the ‘Search’ field. The names of the IND and IDE training modules are included in the “What is this training?” section above.
If you have any questions on the training modules or need assistance with registration in the LMS, you may also contact ORAQ directly at ORAQ-ApplicationRegistration@duke.edu.