Quick guide for researchers

Search for a protocol

The search field allows you to search by:

• the full protocol #,
• the name of the Principal Investigator (PI), or
• the study title.

You can enter parts of the protocol title or PI name.  Wildcards, for example, *, are not required.  Search results will include only the protocols you have access to view and/or edit.

Click a column header in the list to sort by that column in ascending or descending order.

Set and save filters

Setting filters changes the view and limits the number of protocols you see in the protocols list.

1. Click the Manage Protocols page and click the Saved Filters button at the top of the screen.
2. Select No Filter in the Saved Filters Dropdown
3. Click Advanced Filter. Under Filter Rules, select +Add Rule to apply each rule. For example, add the rules below to filter IBC protocols that require revisions.
   
   1. Where | Type | is equal to | IBC
   2. And | Status | is equal to | Revisions Required
4. Click Manage Columns to select/unselect columns to view in the list. After selecting columns to be viewed, click Save at the bottom of the dialogue box.
5. Click into the Save these As box below Filter Rules, enter a short title for your filter, and click the Save button to the right of your entry.
6. Click Saved filters at the top of the screen to confirm your new filter is listed.
7. Before saving another filter, or to reset the list view,  click Saved Filters, select No Filter, or, click Clear All Rules in the Filter Rules box and refresh your browser.

Click on a protocol title from the Manage Protocols screen to open a protocol.  

The top navigation menu includes four tabs, Protocol, Reportable Events, Activity Log, and Permissions.

The Protocol tab contains the protocol form.  The protocol form is intended to be completed from top to bottom.  Additional sections will appear based on responses given at the top of the form.

• The left-hand Jump to navigation menu enables you to jump to the different sections of the protocol form. You can also scroll through the form.
• The Action menu appears on the right.  The Action menu includes the following actions, depending on the state of the protocol.
  • Amend
  • Renew-DO NOT USE
  • Renew/Amend
  • Action Items Summary
  • Admin Notes 
  • Request Close
  • Print
  • Submit
  • Abandon
  • Withdraw
• When clicking on an action item within the protocol, an Action Item dialogue box slides over the right-hand Action menu.

The Reportable Events tab is where the researcher or IBC Administrators will report and process an incident. See Submit a Reportable Event below.

The Activity Log tab contains a chronological history of all actions taken in the protocol since creation.  This is also where Approval correspondence can be retrieved.

The Permissions tab protocol access can be granted to users who are not personnel.  See Personnel and Permissions below.

Personnel and permissions - understanding the difference

Research Personnel:  Individuals who are engaged in research, specifically, individuals who intervene or interact with research activities or access identifiable information for research purposes.

• These individuals are listed in the Personnel section of the protocol form on the Protocol tab
• Adding or removing Personnel from this list requires an Amendment

Permissions: This is a tab within the IRB Protocol that allows individuals who are notPersonnel to be granted access to the study in Kuali Protocols. 

• Full access allows the individual to create submissions, respond to pre-review, and take other actions in the system.
• Read-Only access allows the individual to view the study in Kuali Protocols and download documents such as Attachments and Approval Letters but does not allow the individual to take Actions on the study.
• This tab is always open for editing and no amendment is required to add or remove individuals from the Permissions tab.

Add research personnel

Research Personnel can only be added when the protocol is created, or when amended through an Amend or Renew/Amend action.

In the Research Personnel section of the Form, select the button, "+ Add Line". A new window labeled "Add" will appear.

1. In the field labeled “Person” search for the individual by typing into the labeled field. For best results, search using the individual's IU username.  If you are unsure of username, type last name, first name.
   • Select the person in the filtered dropdown list that appears under the search field. Note that some individuals who do not have an IU username will not display in the search results.
   • If you cannot locate the person you are trying to add, click "Cancel" to exit the window and respond appropriately to the question(s) below the Personnel list to add the Research Personnel who could not be found in the search.
   • Individuals added in this section will be added to Kuali Protocols as a user by staff so they can be added to the personnel list. 
2. Complete the remaining fields and be sure to check all boxes for training required for the personnel.
   • Current training records will populate below training selections. 
3. Click "Done".
4. Repeat steps for each personnel being added.

Edit personnel

1. Click the pencil icon in personnel record to edit personnel details.
2. Click the trash can icon to delete personnel (Note: this cannot be undone)

Add/edit the permissions tab

Individuals can be added and removed from the Permissions tab at any time without an amendment.  However, you must have Full Access permissions to make changes to the Permissions tab. 

1. To add individuals, click the “+ Add User” button and search using the individual's IU username or last name, first name. 
2. To remove individuals, click the “X” next to the individual’s name. 
3. To edit permissions for an individual already in the list, click the dropdown under Permission Type and select the appropriate permissions level, “Read Only” or “Full Access”.

From the Manage Protocols screen:

1. Click the + New Protocol button and select IBC
2. The Kuali Protocols IBC Document will open. Complete the information as indicated below:
   1. Principal Investigator: Begin typing the PI's IU username and select from the filtered dropdown that appears below the search field.
   2. Lead Unit: Auto-populated (if the study is under a different unit than PI, select the appropriate unit)
   3. Title: Enter the protocol title
3. Click the Next button in the upper right-hand corner of the screen. The General Questionnaire will open. Complete all fields in this section.
   1. Questions in this section are required and drive paths in the rest of the form.
   2. Be sure first General Questionnaire question is answered YES.
4. Press the Next button. The full protocol form will open. Complete the fields with data that is appropriate to your protocol and press the Submit button.
5. Once you’ve completed the protocol form click the Submit button and clear any validation errors that display through your protocol form. (They will be highlighted in red) Press the Submit button again and confirm the Protocol screen goes into a Read Only mode and the status updates to Submitted For Review.

If this is the first time you are accessing your protocol in Kuali protocols, the first action you MUST take is Amend, or Renew/Amend. Use the Renew/Amend action if it is time for your annual review, even if you are not making changes to your protocol. Do not use the Renew action.  You MUST select YES to the first question in the General Questionnaire section of the form. This allows completion of the new Kuali Protocol form in its entirety.

If this is the first time you are accessing your protocol in Kuali protocols, the first action you MUST take is the Amend, or, Renew/Amend (even if you are not making changes to your protocol), and you MUST select YES to the first question in the General Questionnaire section of the form.  This allows completion of the new Kuali form in its entirety

1. Log in to Kuali Protocols and search for your protocol.  Open the protocol by clicking on the title.
2. Click Amend or Renew/Amend in the Action menu
3. It is recommended to click on the Attachments Section in the left-hand navigation, and download the Microsoft Word version of your current approved protocol (to copy and paste into the new electronic form where possible) and download the IBC crosswalk to assist in form completion. 
4. If you are adding personnel
   1. Scroll down and click +Add Item on the Person list and complete the required fields
   2. Person: enter IU username
   3. Department: Enter department name
   4. Select ONE of the following roles
      1. Researcher Role: select Principal Investigator, Co-Pl, Key Person
      2. Contact Role: select appropriate administrative role
   5. Select the appropriate training (IBC): Check all required protocol specific training boxes
   6. Confirm that the Read-only permission is automatically assigned when you select the Personnel Research role or any Contact Role.
   7. Scroll to the bottom of the dialog and click Done
5. Scroll down or navigate to each section using the Jump to links on the left-hand navigation and revise your protocol. It is recommended the entire protocol form be reviewed for accuracy before every submission.
6. Be sure to complete any additional sections that are added to the application when you change a response.
7. Once you’ve completed the protocol form click the Submit button and clear any validation errors that display through your protocol form (They will be highlighted in red). Click the Submit button again and confirm the Protocol screen goes into a Read Only mode and the status updates to Submitted For Review (or Resubmitted).

Do NOT take the Renew action!  Instead, take the Renew/Amend action in the Action menu. 
Because the renew action does not allow changes to your protocol, the IBC will only process Renew/Amend submissions.

If you have taken the Renew action by mistake.  Abandon the submission and create a Renew/Amend Submission.  See Create a Renew/Amend or Amend Submission above.

1. Select the link in the Revisions Requested notification you received or log in to Kuali Protocols and search for a protocol.
2. Confirm that your Protocol displays Revisions In Progress in the status column.
3. Click on the Title to open the protocol.
4. Review the Revision Due Date and Revision Required Comment in the Feedback box at the top of the protocol form for guidance on necessary updates.
5. Review the top right-hand side of the screen for General Action Items.
6. Section specific Action Items are identified with a circle in left-hand Jump To navigation sections.  Navigate to each section and select Action Items shown with a circled number or scroll through the protocol and view each field with a circled number next to Action Item.  
7. Click on the Action Item button to view comments.  Click Reply to the Action Item and type in a response.  Then click Post and/or click on the answer to the question and update your response accordingly.
8. Repeat these steps for all fields with an Action Item
9. Be sure to review the protocol for any additional questions that appear as a result of revised responses.
10. Review your updates and make any additional changes that are required.
11. Click Resubmit.

This process may be repeated several times in the review of your protocol submission.

It is important to understand the difference between the Withdraw and Abandon actions.

Once the protocol has been submitted or resubmitted, and is in administrative review, the research team cannot edit the protocol until the administrator requests revisions.  The Withdraw action removes the protocol from administrative review queue to be editable by the researcher.  If you have submitted your protocol, and find that additional changes are needed before review, select Withdraw to revise the protocol form, and Resubmit.  

The Abandon action removes the submission altogether. This action cannot be undone. Do not take the abandon action unless you have decided to delete the submission.

Approved study documents

1. Open the study in Kuali Protocols (more information on searching for studies can be found in the section entitled Manage Protocols)
2. Ensure you are accessing the approved version of the IBC Protocol by selecting the “Approved” version in the “Selected Version” field below the Title
3. Click Protocol Attachments in the left-hand navigation
4. Click on each document you would like to download.  This will open a new window where you can preview the document.
5. Click the “download” button located in the window. 

Download approval correspondence

1. Select the Activity Log tab at the top of the screen 
2. Navigate to the approved submission (scroll to the bottom to view the most recent submission). 
   • Below the Approve action notification text, you will see a link to the approval letter, titled “Correspondence Generated.”
   • Actions are listed in chronological order, with the most recent actions at the bottom of the page. If the Activity Log is long, it may be helpful to click the “^ Collapse All” button to collapse all notifications, which will reduce the length of the Activity Log.
   • If you know the date of the submission's approval, you can also search for the approval action taken on that date.
3. Click on the Correspondence Generated link to open a new tab in your browser where you can view and print the Approval Letter.
   • To print the Approval Letter, either click “Ctrl + P” on your keyboard or go to your browser’s print function.  We encourage you to try different Print settings in your browser to find the Print option that works best for your needs.

Print a copy of the IBC application form

Kuali Protocols was developed primarily to function as an electronic system.  

If you need to print a copy of the Form for your records, click Print in the Action menu.  Currently, the Print function does not allow for printing only of certain sections of the form.  Due to the formatting of certain sections, such as Personnel and Protocol Attachments, the printed PDF may be quite long.  We encourage you to try different Print to PDF settings in your browser to find the Print option that works best for your needs.

1. Log in and search for a protocol
2. Confirm that your Protocol displays a version in Approved status
3. Click on the Title of your protocol.
4. Click on the Reportable Events tab at the top of the screen and press Report an Event
5. Complete all the fields that display and click Submit for Review
6. Click on Activity Log to review the actions that have taken place on this reportable event incident

1. Log into Kuali and access the protocol to be closed.
2. Select Request Close.
3. Complete the close request form and submit.
   1. Address any administrative action items.
   2. Notification will be sent upon approval.
   3. Protocol can be viewed post-closure.