As the reviewing IRB, UW-Madison is responsible for providing ongoing IRB oversight to the study. Follow-on submissions that impact the overall study and/or UW-Madison as a site need to be submitted to the UW-Madison IRBs for review and approval. For changes that only affect a particular site(s), please see the section below on how to submit follow-on submissions for relying sites.
Changes
- 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.
Continuing Review
- If a continuing review is required for your study, only one continuing review application needs to be completed and will cover all relying sites.
- UW-Madison and all relying sites will have the same expiration date.
- Continuing review applications at UW-Madison should be submitted no later than 45 days prior to the expiration date.
- Please use HRP 816-FORM-Site Continuing Review as a tool to collect enrollment information from relying sites. When all relying sites have provided you with their information, please upload the completed version of HRP 816 to the continuing review form.
- Once a continuing review is approved, you as the study team must notify all relying site study teams of the IRB’s determinations, including providing a copy of the approval letter.
Reportable Events
Reportable events (new information, unanticipated problems, noncompliance) that occur at any site for which UW-Madison is serving as the reviewing IRB must be reported to the UW-Madison IRBs pursuant to UW-Madison requirements. You as the lead study team are responsible for obtaining relevant information from relying sites and submitting information to the UW-Madison IRBs for review.
- Once you learn of a reportable event at a relying site, gather the information needed to submit the reportable event to the UW-Madison IRB within the appropriate timeframe.
- To gather information from the relying site(s) where the event occurred, communicate with the relying site study team. You can use HRP-214 – FORM – Reportable New Information to aid in your communication about the event. This form requests the information that is needed to complete the reportable event form in ARROW.
- If you are using HRP-214 as a tool to collect information from the relying site, fully completing the form is NOT a prerequisite for submitting a reportable event and the form does not need to be submitted in the RE. The reportable event should be submitted as soon as the reportable event form can be accurately completed (see the reportable event link above for reporting timelines).
- For the protocol-based and non-protocol-based applications, you will use the same process for submitting a reportable event for a relying site as other reportable events.
- For the sIRB application, any event that meets UW IRB reporting criteria that occurs at a participating site (including UW-Madison), should be submitted as a reportable event in the main study workspace.