Overview
Certain minimal risk studies and all studies involving greater than minimal risk require at least annual review by an IRB. This process is often referred to as Continuing Review or Renewal. Continuing Review/Renewal applications should be submitted in an appropriate amount of time prior to the study expiration date to allow for review of the application, any supporting materials, and responses to questions from reviewers. At UCSD, this is generally 30 days. This KBA will walk users through how to submit a Continuing Review/Renewal application in Kuali IRB.
Steps to Take
1. Start by logging in to Kuali IRB
2. Find the study you wish to submit a continuing review/renewal for and enter the study record by clicking on the blue study title (see blue box in screenshot below).
- NOTE: Be sure you're entering the currently approved version of the study by checking the "Status" column for the words "Approved," "Exempt," or "External Reliance" (see orange box in screenshot below).
3. Once in the study, click "Renew" from the right-hand menu (see green box in screenshot below).
4. The system will automatically generate a continuing review/renewal application.
5. Complete the questions in the "Continuing Review Type" Section and Sections A-D (as applicable) at the top of the renewal application. (For the start of these questions, see the purple box in the screenshot below).
- NOTE: If the study is being reviewed by a non-UCSD IRB, select "Yes" for the question in the "Continuing Review Type" Section to complete a truncated renewal application.
6. If there are any documents to upload along with the renewal (e.g. DSMB or monitoring reports that didn't require prompt reporting, non-UPR log, etc.) these will be captured in the "Attachments" section of the renewal application just after the "Assurances" section (see orange box in the screenshot below).
- NOTE: Depending on whether the study is under the review of a UCSD IRB or a non-UCSD IRB, instructions for which documents are needed will change. Please review the instructions and submit the requested documents.
- NOTE: No other sections of the Kuali application will be editable as a part of the renewal application. To make changes to the study (e.g. update study personnel, update protocol, change informed consent procedures, etc.) please submit an amendment application following these instructions.
7. Once the renewal application questions have been answered and all changes have been made. Click "Submit" from the right-hand menu to submit the amendment to OIA for review (see green box in the screenshot below).