After the reviewing IRB approves UW-Madison as a study site, it is primarily responsible for ongoing IRB oversight. This means that, apart from the exceptions noted in the section below, you do not need to report most follow-on submissions to the UW-Madison IRB. Although specific requirements may vary by IRB and you will need to work with the lead study team to understand those, general reporting parameters are:

After the reviewing IRB approves UW-Madison as a study site, it is primarily responsible for ongoing IRB oversight. This means that, apart from the exceptions noted in the section below, you do not need to report most follow-on submissions to the UW-Madison IRB. Although specific requirements may vary by IRB and you will need to work with the lead study team to understand those, general reporting parameters are:

  • Continuing review
    • If your study requires continuing review, the lead study team is responsible for collecting from you any information the reviewing IRB requires for the continuing review application (e.g., enrollment numbers, subject complaints).
    • Neither continuing review information nor approval need to be provided to the UW- Madison IRB.
  • Changes
    • All changes that affect UW-Madison’s role in the study (e.g., revised study documents, changes in recruitment plans) need to be submitted by the lead study team to the reviewing IRB. The lead study team should work with you when preparing such a change.
  • Reportable Events/Reportable New Information
    • Reportable events should be reported by the lead study team to the reviewing IRB. You generally do not need to submit these to the UW-Madison IRB unless the reviewing IRB determines the event to be severe or the reviewing IRB requires you to report the event to us.
    • If the reportable event is of sufficient severity (e.g., serious noncompliance, unanticipated problem that poses substantial risks to subjects) and/or requires assistance from UW-Madison (e.g., post-approval monitor) to assess, the reviewing IRB is likely to reach out to RELIANT and we will follow up with you regarding next steps.
  • Study Closure
    • When the study is complete at UW-Madison, a study closure must be submitted to both the reviewing IRB and the UW-Madison IRBs.