Consent Document Changes

  • Click "IRB" in the top left navigation area and select the Active tab.
  • Click the name of the approved study.
  • Open a new Modification submission.  Answer all questions.  Upload on the Modification page the reason for revising the consent form.  Include and upload any relevant sponsor correspondence.
  • Click the Documents tab.
  • Click the consent form in the Final column and save it to your computer.
  • Open the document and revise it using the Track Changes functionality in Word to create a document with tracked changes.  Do not use highlighting to indicate changes.
  • Update the version date.
  • When finished, replace the original document with the tracked-changes version in the modification. 
  • When the IRB approves the document, all tracked changes will be accepted and comments removed in the final version.