FDA Form 1571 has been updated. Use this new form for all future IND submissions to the FDA. Refer to this training document to walk you through the changes.
All University of Rochester investigators are required to complete the IND or IDE training before submitting an IND or IDE application (respectively) to the FDA. Training is optional (but strongly recommended) for members of the study team who will be working on FDA-related aspects of the study.
These online courses are available in MyPath for University of Rochester staff and faculty. The same training is available through separate links for the scientific public. Rochester students should request access to this training by contacting the Office of Regulatory Support.
In MyPath use the search bar feature and the keywords "Investigational New Drug" for the IND course and "Investigational Device Exemption" for the IDE course.
MyPath-hosted Courses for University of Rochester Faculty and Staff
The IND and IDE trainings Available to our CTSA Partners and Other Educational Collaborators
These versions are found via the links below. One cautionary note is that the details for submitting these applications are specific to the University of Rochester, so be sure to check with your institution's policies before engaging with the FDA.
Preparing for an FDA Audit
If you are interested in learning a bit more about what happens during an FDA audit and how you can be prepared for one, watch this short training video.