Study teams provide consent documents to the IRB by uploading them in the initial review application. Please see below for guidance on formatting, titling and versioning, previewing consent documents in ARROW, and correcting any errors.
When consent documents are approved by the IRB, they receive an approval stamp and are converted to PDF documents. Fonts and other items in the Word document may introduce slight changes that affect the final formatting of the stamped consent document. To minimize the chances of encountering formatting errors in stamped consent documents, please follow the guidelines below:
- Most importantly, ensure that you are using the most up-to-date version of Word. If a document is created using an older version, click on File and select Convert to update the file type.
- The IRB stamp appears in the lower-right corner so avoid putting items in this corner.
- Use 12 point Arial font throughout the document. Other fonts (e.g., Times New Roman) are known to cause formatting problems when converted.
- Use the following margins: 1″ Top, Right, Left and 1.05″ Bottom.
- Documents with simple or minimal formatting are most likely to convert correctly.
- Tables work best if they are inserted at the top of a page or on a separate page.
- Avoid using text boxes and symbols, which do not convert well to PDF format.
- Do NOT use tab stops to format a document. Tab stops are little blue right angles along the top of the document. To remove tab stops, select the whole document, double click a tab stop, and choose clear all.
Titling and Versioning Consent Documents
When uploading a consent document, you must provide a title for that document. This is important because the title you provide will be displayed in the study’s Documents tab after the study is approved. If a title is not provided, ARROW will display the file name for the uploaded document. As file names are often abbreviated or truncated, providing a clear title for uploaded documents will help avoid confusion. Examples of clear titles include (but are not limited to) the following:
- Main Study Consent
- Genetic Sub-Study Consent
- Study Assent Ages 7-14
The IRB recommends study teams include a version date in the upper left-hand corner of each consent and assent document, using a month/date/year format. The version date should be updated with every revision to the consent document over the course of the study.
Study teams also may use version dates or numbers provided by a sponsor, but are reminded to not use the lower right-hand corner to avoid obscuring the IRB approval stamp.
Previewing Final Documents Activity
The Preview Final Documents activity 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.
Since they are most familiar with how they prefer the consent documents to be formatted, study teams are solely responsible for using the Preview Final Documents activity to ensure the formatting is accurate. 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.
To use the Preview Final Documents activity:
|1. Navigate to the study workspace, if necessary.|
If you have just uploaded consent documents to the application, click Exit to return to the study workspace.
|2. Click on the Preview Final Documents activity.|
This can be found on the left-hand side of the screen, under “My Activities.” A pop-up window will appear.
|3. Select the documents.|
In the pop-up window, select the documents you wish to preview by checking the box to the left of each document and then click OK.
|4. Open the PDFs.|
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.
Correcting Formatting Errors
If you notice a formatting error, the Word document must be revised to remove whatever issue is causing the error. Please make sure the document follows the formatting tips provided above. If necessary, revise the document to meet the guidelines and then upload the revised document and use Preview Final Documents activity again to see if the formatting errors are resolved.
If the document still has a formatting error, please email it to our ARROW help team (email@example.com) for assistance with identifying the cause for the formatting problems.