How to Locate Reportable Event Correspondence in Kuali IRB


OVERVIEW

Kuali IRB automatically generates correspondence letters when a reportable event is resolved in the system by OIA staff on February 9, 2024 or later. Reportable event correspondence will include any decisions or determinations made by OIA or the IRB, as appropriate, with regards to the study and the reportable event so it is important for study teams to review generated correspondence in a timely manner to ensure they comply with any IRB determinations. The below steps allow study teams to review such correspondence within the Kuali IRB system and download it to their computers for saving in study records. 

NOTE: Reportable event correspondence is not located in the same location in Kuali IRB as approval letters. Please be sure to use the steps below to find the reportable event correspondence within the Kuali IRB system. 

STEPS TO VIEW AND SAVE REPORTABLE EVENT CORRESPONDENCE

  1. When a reportable event for a study is resolved in Kuali IRB, the study team will receive an email notification. Study team members with full access or read-only permissions to the study in Kuali IRB are able to navigate to the study application through the link provided in the email or by logging into Kuali IRB at https://ucsd.kuali.co/protocols and opening the study from their Manage Protocols screen by clicking on the study title.
  2. Once inside the study, navigate to the Reportable Events tab using the available selections at the top of the study record within Kuali IRB.
  3. Select the reportable event for which correspondence will be viewed by clicking on the Event Type of the reportable event of interest. Remember, reportable event correspondence will only be available for reportable events resolved on or after February 9, 2024. 
  4. Open the Activity Log for the reportable event by clicking the "Activity Log" button on the right-hand side of the screen. This will cause a pop-up window to open. 
  5. In the pop-up window that will appear, scroll to the bottom of the log and look for a link that says "Correspondence Generated." Click on the link to open the reportable event letter in a new browser tab.
  6. Go to the new browser tab to see the letter. 
  7. If the study team wants to save the letter to their computer, right-click on the letter and select "Print" from the menu. Alternatively, press Ctrl+P on your keyboard. Follow the on-screen prompts to "Print to PDF" and save the letter in the desired location.