Kuali IRB Quick Sheet – Transferring an Existing Study to Kuali IRB


Kuali IRB Application

REMINDER: Transfer existing studies to Kuali IRB at the time of continuing review. Continue to submit amendments for existing studies in the eIRB system until you prepare for transfer to Kuali IRB. For exempt studies and expedited studies that do not have an expiration date, additional information regarding transferring to Kuali IRB will be forthcoming in the next few months.

 

To initiate the transfer process for a protocol in Kuali IRB, research teams must engage in an "Amendment" and a "Renewal":

Amendment: Kuali IRB has a "shell record" of your study loaded when the system launched and needs to be updated with your most recently approved documentation and protocol information.

Renewal: After the protocol Amendment has been submitted, the research team can also submit the Continuing Review right away to be reviewed in parallel by the IRB Analysts.

 

  1. Log into the Kuali Research system and click the box “Protocols” or go directly to Protocols using this link: https://ucsd.kuali.co/protocols/.
  2. Principal Investigators will search for their protocol by IRB number and/or Study Title to find the migrated protocol shell.
    1. IF THE PRINCIPAL INVESTIGATOR CANNOT FIND THEIR PROTOCOL SHELL, PLEASE CONTACT THE IRB OFFICE AT irb@ucsd.edu.
    2. Study Team members who cannot find the protocol shell need to confirm their PI has added them to the "Permissions" tab.
  3. Click on the protocol title that has Initial as the "Submission Type" if there is one line or there are multiple lines for the same protocol:
  4. Principal Investigators must provide study personnel who will prepare the IRB submissions “full access” in Permissions. This is a one-time process that must be completed for each study being transferred to Kuali IRB.
  5. Transferring an existing study involves submitting an amendment and a renewal. We recommend submitting the amendment and renewal concurrently. 
    1. If the protocol has expired, submit the renewal. Once IRB approval is granted, submit the amendment to update the study record.
  6. In the right column, click “Amend” to update the study information in Kuali IRB as only minimal information was transferred from the eIRB system.
    2. Amending the shell protocol involves verifying the Project Basics, updating Funding, Study Personnel and whether UCSD is the IRB for non-UCSD/RCHSD sites.  If other sites are relying on UCSD IRB, you will also need to list those sites in the Participating Sites section.
    3. Click each section to open for updating. You will see on each open section.
    4. Amending the protocol shell, involves:
      1. Updating the status of the study (i.e., enrollment and research activities)
      2. Indicating whether UCSD is the IRB for non-UCSD/RCHSD sites.  If so, listing relying sites in the “Participating Sites” section found at the top of the application.
      3. Describing the amendment type (i.e., “Administrative changes” to transfer study to Kuali IRB).
      4.  Verifying the Project Basics
        •  IMPORTANT: Study Teams need to confirm the correct "Lead Department" is listed.  If "Business and Financial Services (1)" or a Department not associated with the study is displayed, you will need to replace it with the applicable UC San Diego Department for your study.

      1. Listing Study Personnel
      2. Updating Funding, as applicable
      3. Under “Supporting Information”, attaching all the relevant study documentation and most recent IRB-approved documents. This will establish a "living document set" for the study where the documents will be updated and replaced as the study continues and develops. Note: Documents that require stamping (i.e. consent/assent documents and recruitment materials) must be uploaded in PDF format and have the relevant attachment type (i.e. Informed Consent/Parental Permission, Assent, or Recruitment Materials) selected in the Kuali application. Upload the clean, unstamped versions of these documents so the Kuali system can appropriately apply the new stamp. 
    2. No additional changes should be included on this first amendment.
  2.  Click the “Submit” button in the panel on the right side of the screen.
  3. Once the amendment is submitted you may click on “Renew” in the right column to complete a continuing review application.
  4. For additional specific information on how to complete an amendment or renewal, please reference the IRB training videos at: https://irb2.ucsd.edu/researchers/kualirecordings.html.

Contact Us

If you need further assistance, do not hesitate to reach out to the UCSD IRB office at with questions.