Hints for numbering study documents

All protocols, consent forms, HIPAA authorization forms, and other study documents subject to revision should include a version number and date on each page. Whenever you update a document, please remember to update the version number and date on each page to reflect the changes.

Also, when submitting tracked changes versions of documents, please make sure the version number and date on the tracked changes copies match those on the clean copies of the same documents. For example, if you get prereview contingencies to make changes to your protocol version 1, dated Feb. 1, 2015, the documents you submit in response should Protocol ¬†version 2 dated 2.10.15 clean, and Protocol version 2 dated 2.10.15 tracked. Yes, even though it’s the first tracked-changes version ¬†you’ll be submitting, it should still be called version 2. That numbering makes it clear which clean protocol version it’s associated with.