Any modification made to an approved document should be made using the "Track Changes" function, with the exception of Sponsor generated documents, or documents not in Word or RTF format.  The changes made to documents without "Track Changes" capability will need to be clearly described in section XIII.1 or in the comment box (see instructions below). This allows the reviewer to easily identify the changes that have been made, resulting in a quicker review process.  When submitting a new document for initial review, "Track Changes" should not be used.  

All modified documents should be attached as a new version of the previously approved document(s).  The document should not be attached as version 1 of a new document.  By clicking on the Form Modifications tab you will be able to view the changes made to the application (new value vs. old value).  The Version number will be listed in the third column. 

DO NOT delete previously approved versions of any attachments unless you are requested to do so, or recruitment and enrollment is complete (in which case you would remove all documents from the Consent & Assent and Recruitment categories that are no longer being used).

To update/edit application attachments:

• From the Project Summary page, click on Modification/Update Form under Create Form in the upper right hand corner
• Be sure Modification Index is the tab selected
• Click on the Attachment Changes tab
• Select edit for the applicable attachment(s), located on the far right side
• Scroll to the bottom of the page
• Ensure the attachment title is listed and the gold box is titled Edit Electronic Attachment
• Open the document by clicking the link (title of the document) in the gold box
• Save the document to your computer
• Ensure the "Track Changes" function is enabled (see instructions below) and make the revisions
• Save the document, removing and extra characters that have been added (e.g. [1], -1, etc.)
• Select Browse and locate your document
• Click on Upload Document
• Ensure the version number has increased by one (version number is listed in the third column). It should not be listed as a Version 1 document  

To attach an existing modified document:

• From the Project Summary page, click on Modification/Update Form under Create Form in the upper right hand corner
• Be sure Modification Index is the tab selected
• Click on the Attachment Changes tab
• Select edit for the applicable attachment(s), located on the far right side
• Scroll to the bottom of the page
• Ensure the attachment title is listed and the gold box is titled Edit Electronic Attachment
• Select Browse and locate your document
• Clearly describe all changes made to the document
• Click on Upload Document in the comments section of the gold box
• Ensure the version number has increased by one (version number is listed in the third column). It should not be listed as a Version 1 document

How to use the "Track Changes" function in Microsoft Word (Version 2007):

• Select the Review tab at the top of the screen
• Click on the Track Changes button (when selected this will appear colored)
• Ensure your changes are being "tracked" when making revisions

If you do not have the Review tab available you will need to click on the Microsoft logo in the upper left hand corner and select Word Options. Select the box next to Show Developer tab in the Ribbon.

If you are using a Mac:

Macs do not always open RTF documents in Microsoft Word by default.  This causes the "IRB Stamp" to be lost, which will hinder the upload of your consent and recruitment materials.  In order to configure your Mac to open RTF files in Microsoft word, please follow the instructions provided.