To initiate a modification form, log into HawkIRB.  HawkIRB Delegates should click on delegate login and select the PI.

• Under Projects, click on the IRB number of the study you wish to modify.
• In the Create Form box, click on Modification/Update Form.  If you wish to submit a Continuing Review at the same time, click on Modification/Update + Continuing Review Form.
• On the Modification Index, the Frequent Mods tab provides links to areas of the application that are often modified.  
• The Project Index tab provides links to the entire application by section.
• The Attachment Changes tab shows all IRB-approved documents for the study. Use the “Edit” link  to modify attachments. Click the link below the current attachments to attach new documents or delete documents.

When reporting the close of enrollment in a Modification or Continuing Review form, remove Informed Consent Documents and recruitment materials that are no longer needed. Alternately, you may provide justification in Section XIII for why the consent documents should remain attached to the application (i.e. for subjects transferring to the site). 

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).

When preparing a Modification form or during the IRB review process, follow the following process to edit a document. 

• From the Project Summary page, click on Modification/Update Form under Create Form in the upper right hand corner select the "Modification Index" tab.
• Click on the Attachment Changes tab.
  • To initiate the process, click “edit” on the right side of the screen. That opens a yellow box with instructions.
• 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.
  • Use a short, document-specific name to help you upload the correct edited version.
  • Ensure the "Track Changes" function is enabled (located under the "Review" tab in Word and make the revisions.
  • Save the document, removing and extra characters that have been added (e.g. [1], -1, etc.).
  • If you are unable to track changes (in a pdf or Excel spreadsheet), describe the changes in Section XIII of a Modification form or attach a separate document outlining the changes.
• 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. This will save it as a new version on top of the previous version.

The Edit process creates a historical account of the documents being altered.  To view past versions of documents,

1. Open the Project Summary page
2. Click a previous New Project or Modification form
3. Click the + sign to the left of the attachment name to see all previous versions

If you are using a Mac, follow the instructions for how to configure a Mac to open rich text format (RTF) documents.

For PC users:

• 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.

Mac Users:
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, follow the instructions for how to configure a Mac to open rich text format (RTF) documents.