Studies that involve multiple sites and are not exempt typically require a standalone protocol. (Exceptions may include analysis applications where UW-Madison is only receiving data or specimens from external sites.) Your protocol should address how, among other things, the study will be conducted at all study sites (including subject identification and recruitment) as well as how data storage and transfer will be handled. Your protocol also must include a communication plan to describe how distribution of study documents and interactions among sites will be coordinated.

Several tools are available to help you in writing your protocol:

Selecting an ARROW Application Type

ARROW has three application types that accommodate research involving external sites or personnel. Below is general guidance on which application may be most appropriate for your study. Please note this is only general guidance. If you are unsure which application type will work best for your project, please contact RELIANT for assistance.

  • Single IRB (sIRB) Application
    • Best option for studies involving two or more external sites, particularly if subjects will be enrolled at those sites.
    • May be used regardless of the study’s risk level.
    • Requires a protocol.
    • See Using the sIRB Application Type for details.
  • Protocol-based Application (PBA)
    • Best option for studies involving one external site or sites where subjects will not be enrolled AND the study is more than minimal risk.
  • Non-protocol based Application (nPBA)
    • Best option for studies involving one external site or sites where subjects will not be enrolled AND the study is minimal risk.