• For changes to the overall study or that will affect only UW-Madison, you should submit a change as you normally would.
• If the overall study protocol or other overall study documents (e.g., investigator’s drug brochure) is being revised, the UW-Madison study team must notify all relying site study teams of the IRB’s determinations (including providing the approval letter) and, if applicable, provide the latest versions of approved documents (e.g., protocol).
• For changes to consent documents that will need to be implemented at all study sites, submit the change to the template/UW-Madison consent for approval first, then for each relying site.