Completing the Study Location Section

How to complete the Study Location section

What is the purpose of the Study Location section?

The Study Location section of the initial review smartform asks study teams to indicate where their study is taking place. This section also asks study teams to indicate whether the study involves sites or personnel external to UW-Madison/UW Health/Madison VA as well as whether they are requesting that UW-Madison serve as IRB of record for external sites or personnel.

When does the Study Location section display?

The Study Location section will display for every new IRB application. The Study Location section is the third section of the initial review application smartform.

How should study teams answer the first question of the Study Location Section?

The first question of the Study Location section asks study teams if the study is a multi-site study. Study teams should answer "Yes" if ANY of the following are true:

  • The study involves any sites external to UW-Madison/UWHC/Madison VA, including studies that occur at Meriter Hospital.
  • The study involves any personnel external to UW-Madison/UWHC/Madison VA. This includes collaborators and community partners.
  • Data, specimens, or images collected at UW-Madison/UWHC/Madison VA will be sent to an external site or external personnel.

Study teams should answer "No" to this question if the following are true:

  • The study does NOT involve any personnel or sites external to UW-Madison/UWHC/Madison VA.
  • Data, specimens, or images collected at UW-Madison/UWHC/Madison VA will NOT be sent to an external site or personnel.

What if I am not sure about whether my study is a multisite study?

If you are not sure about how to answer questions in this section, please contact the HS IRBs' Reliance Team for assistance.

Tips for Completing the Study Location Section

  • If a study involves multiple UW-Madison/UWHC/Madison VA sites, but NO external personnel or sites, select "No" in response to question 1.1 in this section.
  • If study activities will be occurring only at a UW-Madison/UWHC/Madison VA site, but external personnel will be involved in the conduct of the study or analysis of identifiable or coded data, select "Yes" in response to question 1.1 in this section.

See Also:




Keywords:multisite, external, IRB of record, reliance,   Doc ID:17452
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-24 18:00 CSTUpdated:2017-01-19 13:49 CST
Sites:Health Sciences IRBs
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