Kuali Protocols Overview

Advanced Filters allows you to create and save filters for frequently used searches.

1. Under “Filter Rules” select “Add Rule.”
2. Choose the desired “field” to filter by and the appropriate verb/operator.
   • For example, if you want a list of all of your protocols with expiration dates, you would choose the field “Expiration Date” and the operator “is not blank.” The list of protocols will be filtered to only display IRB Protocols that have expiration dates.
3. You can save the filter by entering a name into the field labeled “Save these as,” and selecting the “🗸save” button.

Manage Columns allows you to select which fields (columns) to display in your results. 

• Kuali Protocols defaults to display the following columns: Title, Number, PI Name, Submission Type, Review Type, Status, Assignment, Continuing Review Date, Unresolved Events, Resolved Events.
  • Note Continuing Review Date is not the Expiration Date. Continuing Review Date is only used for studies which do not require annual renewal and is used to trigger an annual notification for these studies.  You may wish to update your default columns to display Expiration Date rather than Continuing Review Date.
• To change the fields (columns) you wish to display, select “Manage Columns” and choose from the list of available fields.
• Click “save” to see the columns you’ve selected displayed in your search results.
• To return back to the default columns, click on “Saved Filters,” and click “No Filter.”

1. The first page of a new IRB Application requires you to enter three data points.
   • Principal Investigator: Search for the PI’s name by typing into the labeled field. For best results, search using the PI’s IU username.  If you are unsure of username, type last name first, then first name.
     • Please note that the PI must have an IU username. If the PI does not have an IU username, you may request an IU affiliate account here.   
   • Lead Unit: Search for the unit by either typing in the name of the Department or using the Unit ID, e.g., UA-RCIN
   • Study Title: Enter the title of the study
2. Select “Next” on the right-hand side of the screen.
3. On the next screen, select the appropriate Protocol Type from the list provided.
4. Select “Next” on the right-hand side of the screen. This will take you to the main Protocol screen which contains the full IRB Application Form
5. The Form is divided into sections for ease of navigation.
   • For best results, complete the sections and questions in the order they appear.
   • A checkmark will appear next to the section title when all questions in that section have been answered.
   • For a detailed list of the questions that appear in the Form, see the applicable Form Guide on the IRB Forms & Templates page

Study documents requiring IRB/HRPP review must be uploaded in the Form, either as “in-line” Attachments or “Protocol” Attachments.

In-Line Attachments are uploaded within a Form section immediately following a related question. 

• In-line attachments include ancillary review committee approvals, such as radiation safety, and letters of permission from certain external sites
• You will be prompted by the Form when an in-line attachment is required
• Documents uploaded as in-line attachments do not display in the list of approved documents on the Approval Letter

Protocol Attachments are uploaded in their own section of the Form which can be easily located using the left-hand navigation.

• Unless otherwise directed in the Form, study documents requiring IRB/HRPP review and approval should be uploaded as Protocol Attachments
• Documents uploaded to the Protocol Attachments section will be listed on the Approval Letter with Attachment Type, File Name, and Description all appearing
• Version dates or numbers are required for Informed Consent documents
  • The version date must be updated each time the consent is amended
  • The version date must be included in both the document header or footer and in the Description field in Kuali Protocols
  • Stamped or watermarked copies of approved study documents will not be issued. The approved informed consent will be a Word document you can download from the Protocol Attachments section in Kuali Protocols upon approval of your submission

The file size limit for attachments is 30MB. For PDFs that are more than 30MB, use the "compress" feature in Adobe or the "Save as Other" > "Reduced Size PDF" option.

For video or audio files, we encourage you to provide a link to a site that hosts those files (e.g., Google Drive, Microsoft OneDrive or Slashtmp) rather than uploading the video or audio file directly. Contact the HRPP office at irb@iu.edu for additional assistance if needed.

Multiple sections within the Form use lists, which allow you to add multiple entries for a particular question.  All lists function the same way:

• To add an entry, select the +Add Line button
• To remove an entry, select the trash can next to that entry
• To edit an entry, select the pencil next to that entry

• Includes the IRB Application Form, including any Attachments such as Informed Consent documents, recruitment materials, protocols, etc.
• On the left-hand side of the screen you will see the “Jump to..” section. This displays all the sections of the form and allows you to easily navigate to a section by clicking the section title.
• On the right-hand side of the screen you will see a list of available actions.

• Visible only after approval of the initial new study submission
• The Reportable Events tab allows you to create and access Reportable Events
• This section of the IRB Protocol contains its own Activity Log and actions specifically associated with Reportable Events
• For more information, see the Reportable Events instructional guide

• The Activity Log shows the history of all actions taken on the protocol.
  • For studies migrated from KC IRB to Kuali Protocols (identified by a nine or ten digit Protocol number):
    • The Activity Log will only show actions taken since implementation of Kuali Protocols on January 19, 2021.
    • The first Approve action shown for migrated studies will be related to the migration process and is not an actual action taken on the study
    • The history of actions taken in KC IRB can be found on the Protocol Tab at the bottom of the form.
• The Activity Log is organized in chronological order with the most recent actions at the bottom of the list.
• Approval letters are stored in and can be downloaded from the Activity Log.
• Note that the Activity Log will not contain information about Reportable Events.  There is a separate Activity Log for Reportable Events which can be accessed from the right-hand side of the screen in the Reportable Events form.  For more information on accessing Reportable Events, see the Reportable Events instructional guide.

For more information on the Permissions tab, see the Personnel and Permissions instructional guide

The right-hand side of the application Form contains the available actions that can be taken on the IRB Protocol.  These options vary based on status of the IRB Protocol.

The Action menu also includes Admin Notes & Files.  Admin Notes & Files contains the following information:

• HRPP pre-review communications (for more information, see the Responding to HRPP Staff Pre-Review instructional guide)
• IRB Minutes for any submission which required review by the convened IRB
•  Any other notes that are relevant to the protocol.

1. In the “Amendment Creation” window, select the section(s) that need to be amended, then select “Done.” 
   • Sections marked with a lock symbol are unavailable for editing due to another pending Amendment that is editing that section.
2. A new version of the IRB Protocol, including the applicable submission form, will appear.
   • Sections you are amending will be highlighted in green in the Form and marked with a green bubble in the “Jump to” navigation on the left-hand side of the screen.
   • Sections marked with a lock symbol are unavailable for editing due to another pending Amendment that is editing that section.
3. Complete the Amendment form.
4. Make the necessary changes to the selected section(s) in the Form.
5. Click the “submit” button located on the right-hand side of the screen when finished.