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).