12/21/2007, klb
Marking Changes in Documents for IRB Review
How to use the Track Changes feature of Microsoft Word
FAQ and Methods of Use
What is Track Changes?
Track Changes is a way of marking added or deleted text to highlight the ongoing
changes to a document.
Why does the HSC ask for documents showing tracked changes?
Studies reviewed by the HSC frequently contain text that has been changed, either at the
request of the HSC or through proposed amendments to the study since the last time it
was reviewed. Submitting documents with tracked changes enables the HSC to locate and
compare these changes quickly leading to a faster review.
What types of track changes are needed?
Suggested markup includes underline for added text and strike-out of deleted text.
Importantly, the tracked change markup should be obvious after photocopying or printing
to a non-color printer. Yellow highlighting of changed text or showing blue versus black
text is not recommended, as they do not enable changes to be apparent after
photocopying or printing. Bolding of added text is not preferable since some protocols
have text bolded for emphasis, and bolding does not show deleted text. If in doubt,
photocopy a revised page and check if the changes are apparent before submitting to the
HSC.
Note that only changes relevant to the current HSC submission should be marked in
tracked changes. See suggestions below for maintaining version control of documents.
Depending on the default settings in the individual version of Word, the directions given
below will generate a document in which the changes are either shown in the margin in
balloons or as underlined/strikethrough of the text.
Do I need to submit clean copies too?
Yes. The tracked change copies enable the HSC to quickly evaluate the substance of the
revised text, but clean (non-tracked changes), final copies that incorporate these changes
into any documents that will be given to study subjects are required for HSC. Two clean
copies should be submitted.
Suggestions for Maintaining Files and Document Version Control
1. Open the document to be modified and immediately give it a new version name.
For example, if the current document was named HSC12345-Version1, name it
HSC12345-Version2, or attach the date to the document name, such as
HSC12345-v07-12-2007.
2. Turn tracked changes on as described in the guidance below.
3. Revise the document, and save it by going to File and clicking on Save.
4. Print out a copy of the revised document showing the tracked changes.