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.

Application Process

After providing information regarding the PI, on the Type of Application page in ARROW, researchers should select "Protocol Development Activities (PDA)." and the funding should be linked, please see the FAQ Completing the Funding Page. 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.

Keywords:PDA, protocol development, just in time funding, Protocol Development Activities Only   Doc ID:52251
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2015-06-11 12:17 CSTUpdated:2019-11-07 08:29 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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