This section of the Reliance Manual describes follow-on submissions for UW-Madison and/or the study-wide protocol and follow-on submissions for relying sites.
Follow-On Submissions for UW-Madison and/or the Study-wide Protocol
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 (e.g., unanticipated problems, noncompliance, participant complaints) that occur only at UW-Madison must be reported to the UW-Madison IRBs pursuant to UW-Madison requirements.
- Reportable events that may affect the study as a whole (e.g., new risk information, unanticipated event that requires change in study procedures) should be submitted to the UW- Madison IRB pursuant to UW-Madison requirements.
- For reports regarding the study as a whole, you as the lead study team must notify all relying site study teams about the IRB’s determinations, including communicating any corrective action plans.
- Even if the report is for an event that occurred only at UW-Madison, you as the lead study team are responsible for communicating to relying site study teams any unanticipated problems involving risks to participants or other research-related injuries, or significant subject complaints that are related or may affect all study participants at relying sites.
Follow-On Submissions for Relying Sites
As the reviewing IRB, UW-Madison is responsible for providing ongoing IRB oversight for the study and all relying sites. This means that you as the lead study team are responsible for submitting follow-on submissions for relying sites, including changes to study documents at each study site. (Note that the relying study team remains responsible for complying with their own institution’s reporting requirements for any follow-on submissions.) Here are the most common types of follow-on submissions you are responsible for and the process for each.
Changes
All changes made at the relying site must be submitted to the UW-Madison IRB. Unless changes are being implemented to eliminate an apparent immediate hazard to subjects, changes at relying sites cannot be implemented until IRB approval is received. Generally, the process is as follows:
- Use HRP-813 – FORM- Site Modification as a tool to collect information from relying sites (the relying study team completes). After they have completed the form, they should return it to you. You do not need to submit this form to the IRB, but you should retain it for your study file.
- After you have received the completed form (HRP-813 – FORM- Site Modification) from the relying site, you may submit the change to the IRB.
- For the protocol-based and non-protocol-based applications, you will use the same process for submitting a change to a relying site as other changes.
- For the sIRB application, you will use the change button in the relying site workspace. For changes that will affect multiple sites (e.g., consent form revisions), you will need to submit a change for each study site. Note that you can submit changes for multiple sites at the same time.
- Once a change is approved, the UW-Madison study team must notify those relying sites for which a change was submitted of the IRB’s determinations (including providing the approval letter) and, if applicable, provide the latest versions of approved documents (e.g., consent documents).
Continuing Review
If your study requires continuing review, you are responsible for collecting information from each site needed for the continuing review application, including enrollment numbers, withdrawals, and unresolved participant complaints. Please see the “Follow On Submissions for UW-Madison and/or the Study-wide Protocol” section for more information.
Reportable Events
Reportable events (unanticipated problems, noncompliance, participant complaints) 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 learns of a reportable event at a relying site, gather the needed to submit to the UW-Madison IRB within the appropriate timeframe.
- To gather information from the relying site(s) at which the event occurred, complete HRP 814-FORM-Site Reportable Event with the relying study team. After the relying site study team has reviewed and signed the form, they should return it to you. You do not need to submit this form to the IRB, but you should retain it for your study file.
- Receipt of the signed HRP-814 from the relying site is NOT a prerequisite for submitting a reportable event. The reportable event should be submitted as soon as the reportable event form can be accurately completed.
- 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 via the main study workspace.
- Once review of a reportable event is completed, you as the study team must notify all relying site study teams affected by the reportable event of the IRB’s determinations, including communicating any corrective action plans.
- The relying site study team is responsible for consulting with their own IRB about whether any additional reporting is needed to their own IRB.
- Note that you as the lead study team are responsible for communicating to relying site study teams any unanticipated problems involving risks to participants or other research-related injuries, or significant subject complaints that are related or may affect study participants at all relying sites.
- If the event is of sufficient severity, UW-Madison will consult with the relying site’s IRB and will coordinate with that IRB regarding any corrective action plans, reporting to federal agencies (if applicable), and post-approval monitoring.
Personnel Changes
Relying site study teams are responsible for consulting with their own IRB about what personnel changes need to be reported to their own IRB. Personnel changes that need to be reported to UW-Madison include:
- Change in PI at the relying site, which need to be reported at the time they occur.
- Updates to delegation logs, which only need to be submitted every 6 months.