In the cede application, you will be asked to upload the IRB-approved study protocol or, if no study protocol is available, a copy of the IRB-approved application. The lead study team will need to provide you with this document. Whichever document you use, it will need to clearly describe the role of UW-Madison/UWHC in the study. This is important because the institution cannot cede IRB review without knowing what study activities will be occurring here, including who from UW-Madison/UWHC will be involved in the study. RELIANT uses this information to assess whether the study qualifies for ceded review and to identify any institutional requirements that must be met before study activities can commence at UW-Madison/UWHC, as applicable.
If neither the IRB-approved study protocol or application describe UW-Madison/UWHC’s role in the study, you will need to complete HRP-508-TEMPLATE SITE SUPPLEMENT and upload this in your cede application. This will provide RELIANT with the information needed for its review process. Some sections of the site supplement may not apply to your study and you may edit the document as needed.