Document Change Process Overview

As a result of IRB reviews or changes to research, the study team may need to make changes to a study's documents.

Use of Word “Track Changes” functionality is recommended so that changes may be easily identified for reviewers. When the documents are finalized, IRB system software will automatically accept the changes and remove any comments in the final versions. Refer to local IRB guidance regarding any requirements associated with including and reviewing documents with “Track Changes” enabled. The following are suggested practices based on system capabilities.

Document Change Table

Note: Use of drag and drop to upload revisions of existing documents ordinarily records an update to the system version number and may not trigger an entry in the view differences version of the SmartForm.  If you expect that a document was changed and it does not display in view differences mode, use the document history view link to confirm if a document change has been recorded in the system.