Quick Reference – Submit a New Protocol Application
1
On the Researcher landing page, in the middle column of the page, click the first link in the box named “Create IRB Protocol”.
2
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 from the drop down list.
2. Type the title into the Title field.
3. Select the PI.
4. Verify or correct the Lead Unit
3
Click the “Save” button at the bottom of the page to save your work get a Protocol Number.
4
Complete information in the bottom four folders of the Protocol Tab
Additional Information = areas of research, identifiers and summary/keywords.
Organizations = performance sites.
Funding Sources = sponsor(s).
Participant Types = vulnerable populations.
5
On the Personnel Tab:
Add all other personnel who will be involved in the project.
Remember to click the “add person” button for each name.
6
On the Questionnaire Tab:
Complete all Questionnaires appropriate to your application type.
(*Picture does not represent a complete list)
7
On the Notes and Attachments tab:
Add all materials assocatied with this application.
This includes but is not limited to: COI forms, data collection tools, surveys,
protocol narratives, questionnaire overflow forms, ICF and waiver forms.
Remember to click the “add” button for each file.
8
On the Protocol Actions Tab, in the Ad Hoc Recipients Folder:
Use the search to enter the P.I. (if not yourself), department head and or
college dean if submitting to Biomed as a Convened Protoco
Remember to click the “add” button after each name.
9
On the Protocol Actions Tab, in Request an Action Folder:
Complete the Submission Type, Submission Review Type, Committee and
Schedule Date drop down boxes.
Click the “Submit” button.
10
After submission you will see the following message:
Kuali Transactional Document Postprocessing Holding Page
Congratulations, you have submitted your protocol.
Note that any ad hoc approvers must approve the
amendment 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!
If you have any issues during this process, contact the Research Systems Team at 419-383-6651 or email Jamie.VanNatta@utoledo.edu.