When submitting revised documents to the IRB, either in response to contingencies or with modification forms, the IRB asks that you include clean and tracked-changes copies of all of the items being changed (particularly protocols, consents, and HIPAA authorizations). When creating tracked changes documents, please make sure all of your changes are tracked, including deletions. We have seen some submissions where study teams manually highlight all additions to a revised form, which seems like a lot of work to us, and then don’t mark where they have deleted content. So that’s more work both for the study team, and for the reviewer(s) who will eventually need to look at the changes.
The easiest way to track all changes is to use the “track changes” option in Microsoft Word. Once you have created a tracked-changes document, save it as your tracked-changes version. Then click the “accept all changes” button to magically create a clean copy, which you can then save.
Please note that tracked-changes versions that don’t mark all of the changes may be returned to you for correction before being reviewed.