IRB Guidance: Protocol Development Activities
This page provides guidance for completing an application for Protocol Development Activities (PDAs) only.
The Protocol Development Activities Only submission form is to facilitate the submission of grant applications to the IRB for review when:
- Research activities involving human subjects are planned for the future but have not been finalized (for example, the grant incorporates a planning stage), OR
- When a Study Team has received a "just-in-time" request for documentation from an IRB.
In order to obtain approval for research activities involving human subjects, a separate Initial Review application is required.
After providing information regarding the PI and the funding source, (including a copy of the full grant application with the budget), on the Type of Application page in ARROW, researchers should select "Protocol Development Activities." The questions/pages that will generate in the ARROW application will be related to non-human subject activities.
Only planning activities that do not involve human subjects can be covered by this administrative approval, and an Initial application will need to be submitted to the IRB for review and approval prior to any research activities that involve human subjects.
PDAs are reviewed only for the role UW Madison will have in a project. Non-UW personnel should not be included on a PDA.