Multisite studies involve communication among many stakeholders and, as a lead study team, you will be responsible for developing clear lines of communication. Therefore, when you are planning a multisite study for which UW-Madison will serve as the reviewing IRB, one of the most important documents you need to create is a communication plan. A robust communication plan helps ensure that your collaborations with relying sites will run as smoothly as possible. The communication plan needs to be included in your study protocol or, for non-protocol based studies, uploaded in your IRB application. For guidance on developing this plan, see HRP 830-WORKSHEET-Communication and Responsibilities. The purpose of a communication plan is to clearly outline the roles of the four main groups involved in multisite studies:

• Lead study team (including the lead PI)
• Relying site study team (including a local PI)
• Reviewing IRB (UW-Madison when serving as the sIRB)
• Relying site IRB/HRPP

Some of the elements of a communication plan include:

• Who provides IRB documentation to relying sites as well as how and when
• How changes to the overall study and/or sites will be prepared and submitted
• Management of continuing review information
• Plan for handling reportable events

Please keep in mind that while RELIANT provides support to UW-Madison study teams navigating reliance and institutional requirements for human research, we cannot answer questions from relying site study teams about their own institutional requirements or IRB submission processes, including how to request IRB review be ceded to UW-Madison. We encourage you to work closely with your collaborators to ensure they are in contact with their own IRB early in the reliance process; this will help make the review process move more efficiently.