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Listing Study Team Members in the Application

Where to List Study Team Members in the Application SmartForm

Where should the Principal Investigator (PI) be listed in the application?
  • Anyone listed as PI in the application can edit and submit the application as well as create and submit changes, continuing reviews, and reportable events for the study (if applicable). The PI also receives any email notifications about the study.
  • The PI should be listed on the first page of the IRB application in response to question 1.5
  • If the PI will not designate any points of contact for the study, he/she also should be listed in response to question 1.6 on the first page of the application.
  • The PI should NOT be listed on the Study Team page of the application. Please see below for information on who should be listed on this page.
  • The PI should be listed on the Study Team: Roles page, where applicable.
  • If the study involves certain types of procedures, the PI may need to be listed (if appropriate) where requested elsewhere in the application (e.g., cognitive assessments page)

What is a Point of Contact and where should a point of contact be listed in the application?

  • A point of contact (POC) is someone designated by the PI to serve as a point person for a study. A POC has the same level of access as the PI to the application. Up to four POCs can be listed for a study. NOTE: This applies ONLY to the HS and MR IRBs.
  • Anyone listed as a POC in the application can edit and submit the application as well as create and submit changes, continuing reviews, and reportable events for the study (if applicable). The POC also receives any email notifications about the study. NOTE: While PIs may delegate research responsibilities to others, they retain ultimate responsibility for the conduct of those to whom they delegate research responsibilities
  • Any POCs should be listed in response to question 1.6 on the first page of the application.
  • POCs should NOT be listed on the Study Team page of the application. Please see below for information on who should be listed on this page.
  • POCs should be listed on the Study Team: Roles page, where applicable.
  • If the study involves certain types of procedures, a POC may need to be listed (if appropriate) where requested elsewhere in the application (e.g., cognitive assessments page)

Who should be listed on the Study Team page of the application?

Except for the PI and points of contact, all study team members must be listed on the Study Team page of the application, This should include all study team members (except the PI and POCs) who are engaged in human subjects research and fall under the purview of a UW-Madison IRB. Study team members may be granted edit access or read-only access, as described below.

What is the difference between edit access and read-only access on the Study Team page?

  • Edit access: Any study team member listed in this category will be able to edit the application and receive email notifications from ARROW regarding this study. Those with edit access may not create or submit applications for a study, but they can edit a submission after it has been created. Only a PI or a POC can create and submit applications in ARROW.
  • Read-only access: Study team members listed in this category will only be able to read the application and will not receive email notifications from ARROW.

Do the PI and/or Point(s) of Contact need to be listed as having edit or read-only access?

No. The PI and POC listed on the first page of the application do NOT need to be listed again on the Study Team page. Those listed as PI and POC automatically have edit access to the application and will receive all email notifications related to the study.

Who can submit materials to the IRB through ARROW?

Only people listed as the PI and POC can submit materials to the IRB through ARROW.

Where should study team members' roles be listed?

Study team members who identify and recruit subjects, obtain informed consent, and/or interact or intervene with subjects must be listed on the Study Team: Roles page of the application.

What if study team member has a role not listed in the application (e.g., data analysis)?

Some study team members may not need to be listed on the Study Team: Roles page if their role is limited to data analysis or another activity not listed on this page. The role(s) of these study team members should be listed in the study protocol, if applicable.

Do study team members outside UW-Madison/UWHC/Madison VA need to be listed in the application?

External study team members should be listed as key personnel ONLY if UW-Madison is serving as their IRB of record. Do NOT list external study team members in the study team members pages if their study activities will be overseen by another IRB or they are not engaged in human subjects research. These individuals should instead be listed in the study protocol.

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Keywords:PI, POC, Point of Contact, Principal investigator, key personnel, personnel, edit access, read-only access   Doc ID:17226
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-07 18:00 CSTUpdated:2016-12-27 14:07 CST
Sites:Health Sciences IRBs
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