This course will describe the IRB submission and review process for Changes of Protocol. Topics covered will include: What constitutes a Change of Protocol? What is the difference between an expedited and full Change of Protocol? How should changes be presented in the ARROW application? What is the process once the change is submitted? The presenters will also touch on special topics, such as changes to multi-site studies (reliance considerations) and when a change may need to be accompanied by a Reportable Event.
For registration questions or to register after the deadline, contact Emily Putman-Buehler (emily.putman@wisc.edu)