In order to move to any of the other tabs, you must complete information on the Protocol tab first. Once you have completed all required fields, you can save the information and move to the next tab.
Required Fields for Saving Document
- Protocol Type: Reliance Request
- Title: Enter the title of your study.
- Principal Investigator: Identify the Principal Investigator (PI) by:
- Entering the user ID in the box and pressing the Tab key, which will populate the PI Name and Lead Unit; OR
- Click the magnifying glass button, which will bring up a search window. Enter the PI’s Last Name in the appropriate field and click search. Helpful Tip: using the "*" before or after a person's name is helpful in ensuring the correct person is found. For example, "Johnson*".
- Click "return value" next to the appropriate person. This will populate the PI name and lead unit on the Protocol tab.
- Additional Information: (For studies that involve an IDE/IND ) Click ►show
- FDA IND or IDE #: Enter IND or IDE #, if applicable; if none, leave blank. If multiple INDs/IDEs, separate with semicolon.
- IU or Investigator held IND/IDE? Y/N: If there is an IND/IDE, enter Y or N to identify whether IU or the investigator holds it.
- No information should be entered in the remaining fields in this section.
- Organizations: Add IU affiliated organizations (locations) that are engaged in the research, i.e., any organization where subject records will be accessed, or where research related interactions and/or interventions occur. For more information on IU affiliated organizations, go to: IU-affiliated research personnel.
- Select the magnifying glass icon, which will bring up an organization lookup listing frequently used organizations. From the list, check the box or boxes for the organization(s) engaged in the research.
- If the organization you are searching for isn't listed, change the value in the Organization Type field to “select” and click search to return all organizations included in the KC Organizations database.
- To narrow your search, enter part of the organization's name in the Organization Name text box (e.g., *health*).
- Check the box or boxes for the organization(s) engaged in the research.
- Click the "return selected" button. All organizations checked will populate onto the Organizations panel on the Protocol tab.
- Funding Sources: All studies must have some kind of funding source listed. If your study is not funded, select “Unfunded” from the dropdown and click the “add” button. For additional information about how to add funding sources, refer to the Quick Guide: Adding Funding.
- Participant Types: Please identify any vulnerable populations that will be enrolled at IU from the dropdown menu, and click the “add” button to finalize your entry. Note: You do not need to enter a count.
Once all required information has been entered on the Protocol tab, click save and navigate to the next tab.
For information regarding who should be listed on this tab, please refer to Quick Guide: Research Personnel.
- The Principal Investigator identified on the Protocol tab will display in the first folder on the Personnel tab.
- For additional information on how to add Personnel, refer to the Quick Guide: Adding or Removing Research Personnel
- Conflict of Interest Questionnaire: Once all personnel have been added, the Conflict of Interest Questionnaire should be completed.
- Click save and navigate to the next tab.
Study personnel are automatically assigned certain permissions based on the protocol role assigned to them on the Personnel tab. The Permissions tab is where additional persons who need access to the KC IRB Protocol, but aren’t directly engaged in the research. e.g., an administrator whose only role is to submit items to the IRB, are added. For additional information about how to add persons to the Permissions tab, please refer to the Quick Guide: Permissions.
Individuals who need to edit the KC Protocol or receive notifications should be designated as Study Manager/Correspondent; otherwise, use the Viewer role.
Click save and navigate to the next tab.
When the item is ready for review, it must be submitted in the KC system via the Protocol Actions tab.
- Click ►show on the Request an Action panel.
- Click ►show next to Submit for Review.
- Submission Type: Initial Protocol Application
- Submission Review Type: IRB Review not required
- Click submit.