Quick Reference – Creating a Protocol Application for External IRB
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On the Researcher landing page, in the middle column of the page, click the first link in the box named “Create IRB Protocol”.
The Protocol Tab:
Document Overview Folder
1. In the description field, type your last name, the PI’s last
name if different, and one or two key words from the title of
the research project.
Required Fields for Saving Folder
1. Choose the Protocol Type = “Other IRB Review”.
2. Type the title into the Title field.
3. Select the PI.
4. Verify or correct the Lead Unit
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Click the “save” button at the bottom of the page to save your work and get a Protocol Number.
Complete information in the bottom four folders of the Protocol Tab
Additional Information = areas of research, identifiers and summary/keywords.*
*In summary/keywords field, type the name of the external IRB you want to use.
Organizations = performance sites.
Funding Sources = sponsor(s).
Participant Types = vulnerable populations.
On the Personnel Tab:
Add all other personnel who will be involved in the project.
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Remember to click the “add person” button for each name.
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On the Notes and Attachments tab:
Add all materials assocatied with this application.
This includes but is not limited to: the signed checklist for
external review, COI forms, data collection tools, surveys,
protocol narratives, ICF and waiver forms.
Remember to click the “add” button for each file.
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On the Protocol Actions Tab, in the Ad Hoc Recipients Folder:
Use the search to enter the P.I. (if not yourself)
For an External IRB application, you must have the signature of
the PI. If you are the PI, then no signature is required as the
submission is the signature
Remember to click the “add” button for each name.
On the Protocol Actions Tab, in Request an Action Folder:
Complete the Submission Type =”Initial…”
Submission Review Type = “Response”
Committee = “Biomedical”
Schedule Date = Next available date.
Click the “Submit” button.
After submission you will see the following message:
Kuali Transactional Document Postprocessing Page
Congratulations, you have completed the
application for submitting to an External IRB.
Note that any ad hoc approvers must approve
the application before it can be pre-reviewed
by the IRB. You can click “Return to Portal” at
any time.
If you don’t see this message, please check for
errors in your application. Errors will be
displayed in the Validation folder on Protocol
Actions tab.
* Because there are currently no notifications in KC, remember to communicate with your signatory upon submission!
Once your approval signature has been collected, the IRB administrators will review your protocol for completeness make a determination on
submitting the protocol to an external IRB for approval.
If you have any issues during this process, contact the Research Systems Team at 419-383-6651 or email Jamie.VanNatta@utoledo.edu.