Since the IRB has started allowing the submission of only tracked-changes copies of revised documents, we’ve found that our reviews are a little easier, and CLARA document files are a little cleaner, for studies that only submit the tracked-changes copy.
Therefore, the IRB now asks that you submit only a single copy of any revised documents, using Microsoft Word’s “track-changes” feature to show what has changed. The IRB can create clean copies by changing the view in Word.
You would “stack” the tracked-changes version atop the previous “clean” stack, if there is one, and then add a note in CLARA telling us you’ve done so. That will allow us to “retire” the tracked-changes stack for that document.
The IRB asks that you submit separate clean and tracked-changes copies only if your document is not created in Word or if your sponsor has provided clean and tracked-changes copies to submit as is.