FDA regulated research is a complex space to move through whether one is novice, or well-seasoned. Clearly understanding the roles and responsibilities of both the Sponsor-Investigator and the research team takes experience, time and patience.
We are delighted to host the only dedicated Investigational New Drug (IND) and Investigational Device Exemption (IDE) support service on the UW-Madison campus. Working with our IND/IDE team is the most efficient way for an investigator to navigate this important process and minimize unnecessary steps.
Are you unsure whether you need to file an Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application with the FDA? Not sure if your study is exempt?
Please complete an online consult form here so that we can lend you support and guidance through this process.
Guidance and templates are available on these pages, but we strongly encourage you to work with our team before taking any action.
Do I need an IND? (Drug or Biologic)
- Content & Format of an IND initial submission
- IND Lifecycle Reporting
Do I need an IDE? (Medical Device)
- Content & Format of an IDE initial submission
- IDE Lifecycle Reporting
- Meetings with the FDA – IDE
- Meetings with the FDA – IND
- Preparing for an inspection by the FDA or other entity
Per Policy: Training for UW-Madison Investigators Who Hold an IND or IDE (located under the Training and Education section here: https://kb.wisc.edu/hsirbs/page.php?id=85093) the following course must be completed before initiation of a human subjects clinical trial that is being performed under an Investigator held IND/IDE.
- Understanding Your Responsibilities of Holding an IND/IDE with the FDA
- The online course titled “Understanding Your Responsibilities of Holding an IND/IDE with the FDA” offers information to both new and experienced faculty that hold an IND or IDE application with the FDA. The course reviews the responsibilities that come with this activity, as well as pointers and tips that can be applied to help along the way.Although this training has been developed specifically geared towards faculty that hold an IND or IDE application, the content is applicable to others members of the team.
- To enroll in the online training course, go to: https://canvas.wisc.edu/enroll/BR4Y6L and click on the “Enroll in Course” button.
- Click the “Go to the Course” button.
- If you start the training, but must return at a later date to finish the training, go to: https://learnuw.wisc.edu/, login with your NetID and select the course from your Dashboard.
While not mandatory, the following course is highly recommended for those conducting human subjects clinical trials at UW:
- Basics of Conducting Research at UW
- To enroll in the online training course, go to: https://canvas.wisc.edu/enroll/WBAJ4R and click on the “Enroll in Course” button.
- Click the “Go to your Dashboard” button.
- Select the “Basics of Conducting Clinical Research at UW-Madison” course available on the bottom of the screen to get started.
Other good sources for training related to FDA Regulated Research:
- CITI Good Clinical Practice (GCP)
- Sign up here: https://my.gradsch.wisc.edu/citi/index.php
- Other institution training
- UW-Madison Investigator Held IND/IDE Policies and Resources
- Resource Library
- IND/IDE Related Templates
- FDA Resources for Drugs and Devices
- Clinical Research Toolkit