Using the Preview Final Documents Activity in ARROW

Using the Preview Final Documents Activity in ARROW

What is the Preview Final Documents activity?

The Preview Final Documents activity allows study teams to preview what consent and assent documents (as well as information sheets) will look like after they are approved in ARROW.

Why is the Preview Final Documents activity needed?

When consent forms are approved in ARROW, they are converted to PDF format. During the conversion process from Word to PDF, errors in formatting may appear, especially if the Word document contains complex tables, images, and/or is not formatted according to HS-IRBs guidelines. The errors are NOT caused by ARROW, but rather by program coding differences between Microsoft Word and Adobe PDF.

Preview Final Documents allows study teams to check for any potential formatting errors prior to the documents being approved by the IRB. Previewing documents during pre-submission or during the IRB pre-review process allows study teams to revise the documents so that they will format correctly when approved by the IRB.

The only way to fix formatting errors that appear after a document has been approved by the IRB is to submit an expedited change. This is why it is important that documents be previewed before they are approved by the IRB.

Who is responsible for checking consent documents for formatting errors?

Study teams are solely responsible for using the Preview Final Documents activity to check for any formatting errors. Study teams are best able to identify formatting errors in consent documents that they have developed. The HS-IRBs office will continue to review the content of consent documents to ensure they meet the relevant regulatory and institutional requirements.

After August 1, 2011, study teams who do not preview their documents and find a formatting error in IRB approved documents will be charged a fee for the expedited change required to fix the error if the study is not exempt from IRB fees. Study teams who have used the Preview activity and still find an error that did not previously appear in an approved document will NOT be charged if an expedited change is required.

When should study teams use Preview Final Documents?

The Preview Final Documents activity is avaiable to study teams in several places in the IRB workflow. Study teams are advised to use Preview Final Documents at the following times:

  • Before submitting a new IRB application or a change of protocol that includes revised consent or assent documents
  • Before responding to issues during the pre-review process if revisions were made to the consent or assent documents
  • Before responding to IRB modifications or a deferral if revisions were made to the consent or assent documents

How do I preview my consent documents?

To preview consent documents, they must first be uploaded to the appropriate section of the IRB application in ARROW. After the documents have been uploaded, exit the application and click on the Preview Final Documents activity link on the left side of the submission workspace:


After you click this link, a pop up box will appear. Select the documents you wish to preview by checking the box to the left of each document and then click OK.


After clicking OK, the History tab will update to include PDFs of the documents you selected for preview. Click on the link for each document to see the preview of what the document will look like after it has been approved by the IRB.


What if I notice a formatting error when previewing documents?

If you notice a formatting error, this means that the Word document must be revised. Before making any revision, please review Formatting Consent Documents for ARROW . If necessary, revise the document to meet the guidelines and then upload the revised document to the IRB application in ARROW. After the revised document is uploaded, be sure to use the Preview Final Documents activity again to check for any additional formatting errors.

What if the document is formatted according to the guidelines and still has an error?

If the document still has a formatting error, email your document to to get assistance with identifying the problem and revising the document. Please put “Consent Formatting Help” in the subject line. As some consent documents may take a significant amount of time to reformat, please allow at least 2 business days for processing.

Keywords:preview final docs, convert to PDF, ICF check, consent form check   Doc ID:18856
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-06-15 19:00 CDTUpdated:2015-10-13 15:09 CDT
Sites:Health Sciences IRBs
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