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Modifying an Approved AUP

Who can modify?

Protocol details in Word Document or AUP form?

Create Mod

Complete the Mod Tab in RMS

Upload Attachments to Mod Tab

Respond to Review

Personnel Changes

Additional Guidance


Note:  Only 2 roles have permissions to create, edit, and submit modifications: "Principal Investigator" and “Co-Investigator/Senior Researcher”

If you do not have either of these roles, email IACUC@uci.edu for assistance


Before starting a modification, identify where your protocol details are in RMS. This will determine what your next steps are. 

If they are in...

Word document:

  • Complete the Modification Tab in RMS (Step 1)
  • Revise the Word document protocol narrative (and any relevant appendices) using Track Changes
    • Editable versions are available in RMS as attachments to the File level - Look for the paperclip icon next to your File (right-click or Ctrl+click (Mac) to view attachments)
    • If not in RMS, email IACUC@uci.edu to request for an editable version.
  • Upload your revised documents as attachments in the Modification Tab (not anywhere else in RMS)

AUP form fields:

  • Complete the Modification Tab in RMS (Step 1)
  • Incorporate all proposed changes into the relevant Protocol Tabs

  1. Go into the protocol, click the Modification button to create a new Modification version.

       
    Note:  If you do not see the Modification button in the menu, you may not have edit permissions. Email IACUC@uci.edu for assistance.

    A comment window will pop up - You may leave blank or enter optional notes, then click the button.

     
      
  2. The Modification Tab will now appear at the top, and the protocol status/version will indicate "Modification".


  3. Enable editing by clicking the Check-out button


  4. Fill out the Modification Tab form - This acts like a cover letter to all proposed changes in your modification request.
    Mark the applicable checkboxes and answer any required subsequent questions.


  5. Incorporate your proposed changes into the protocol...

    • Word document:
      • Turn on the Track Changes feature and revise the relevant sections in the Word doc
      • Upload the revised Word docs as an Attachment into the Modification Tab - Click on the  button, a window will pop up for you upload attachments

    • AUP form fields:
      • Revise the relevant tabs and sections in the AUP form
      • Tip:  Guidance on which tabs/sections to update can be found by hovering your cursor over the  purple info icon
        (Refer to guidance about specific protocol tabs from the RMS User Guide)

  6. SAVE your work periodically - Click the  button.
      
  7. Once you're ready to submit, click the Submit to IACUC button.
     

    A comment window will pop up again - You may leave blank or enter optional notes about your submission, then click the  button to complete submission.



  8. Email IACUC@uci.edu to let us know you've submitted a mod.
  9. Once your modification is sent out for review, additional clarifications may be needed - Keep an eye on your emails! See Guidance on Responding to Pre-review.

Personnel Changes

After completing Steps 1-4 above, go to the Personnel Tab to add/remove users.

If you cannot find a user to add, they may not yet have a RMS user profile - Fill out the Mod Tab to "Add Personnel", providing their UCInetID. Once your mod is submitted, IACUC admin will process the personnel changes.



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