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OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

This RAMS Gif Guide is intended for those who perform department reviews. This guide will walk users through the processes needed to perform a department review, including navigation, reviewer note functions, and accessing documents.

This guide only covers the technical aspects of navigating RAMS-IRB to conduct department reviews. If you require guidance on the scope of department reviews and what department reviewers should be looking for, please contact the HRPP’s Education & Outreach Manager.

You can access more RAMS Gif Guides by using the RAMS Gif Guides tag on our blog.

Navigating to a Study that Requires Department Review

First, log into RAMS-IRB, being sure to connect to the VPN if necessary.

Next, ensure that “IRB Submissions” is selected under the “My Roles” menu. Most investigators will not have this many “roles” in RAMS-IRB, but if you do have more than one “role” (i.e.: IRB Committee Member), make sure that “IRB Submissions” is selected. [View Image]

Ensure that the “Inbox” tab is selected. All studies requiring action on your part will appear under this tab. Studies requiring Department Review will say “Department Review” under the “State” column. Click on the hyperlinked title of the study to be brought to that study’s main workspace. [View Image]

To open the SmartForm for the study, select the “View Study” button under the “My Study Forms” menu. [View Image]

Navigation in the SmartForm

There are a few different ways to navigate a study’s SmartForm. To jump to a specific page of the SmartForm, select the “Jump To” menu, and then select the page you’d like to go to. [View Image]

You can also use the “Back” and “Continue” buttons to navigate to adjacent SmartForm pages. [View Image]

To exit the SmartForm and return to the main study workspace, click the “Exit” button. [View Image]

Adding, Editing, Deleting, and Navigating Reviewer Notes

To add a reviewer note, click the “Add” button. In the pop-up window, select “Department Draft Change Request” from the drop-down menu, and then type your reviewer note in the text box. Click “OK” when finished, and the reviewer note will appear at the top of the SmartForm page. [View Image]

To edit a reviewer note, click on the hyperlinked “Department Draft Change Request.” The note will become editable in a text box. Click “OK” when finished editing, and the edits will be saved. [View Image]

You can jump between SmartForm pages that have reviewer notes logged on them by using the “Next” and “Previous” buttons. “Next” will take you to the next page that has a reviewer note on it, skipping all pages without a reviewer note. “Previous” will likewise take you to the previous page that has a reviewer note on it, skipping pages without reviewer notes. [View Image]

To delete a reviewer note, click the “Delete” button. In the pop-up window, select which note you wish to delete by checking the box next to it. You can distinguish between notes based on the time they were logged, or by which page they are logged on. Once a note(s) is selected, click the “Delete” button, and the reviewer note will be deleted. [View Image]

To view a list of all reviewer notes, navigate to the main study workspace and click the “Reviewer Notes” tab. There you will be able to see all of your reviewer notes. [View Image]

From the “Reviewer Notes” tab, you may also jump to the SmartForm page that the note is logged on. Click the hyperlinked page title next to “Jump To” to be taken to that page of the SmartForm. [View Image]

Accessing Documents

There are a couple ways to access documents. From the main study workspace, select the “Documents” tab. Scroll down to the document you wish to access, and click “View.” In the pop-out window, click the hyperlinked title of the document to open or download the document. [View Image]

Documents can also be accessed within the SmartForm. Navigate to any page that contains a document upload spot, such as the Study Procedures or Documents pages. Scroll down to the document you wish to access and click “View.” In the pop-up window, click the hyperlinked document title to open or download the document. [View Image]

Requesting and Reviewing Changes

When you have finished reviewing and logging reviewer notes, return to the main study workspace. Click the “Changes Requested by Department Reviewer” button. In the pop-up window, enter any instructions or additional comments in the text box (not required), and click “OK.” This will send the study back to the PI for changes. [View Image]

Once a study has been returned to you with changes, navigate to the main study workspace, and click “View Differences.” RAMS-IRB will highlight changes for you by providing the current response to a question and highlighting additions in green. The previous response to a question is shown immediately below, and deletions are highlighted in red and have a strikethrough. [View Image]

You can navigate between SmartForm pages that have changes made on them by selecting the drop-down menu next to “Changed Steps” and selecting the page you want to jump to. You can also navigate through pages with changes on them sequentially by using the forward arrow (>>) and back arrow (<<) buttons. This form of navigation will only take you to pages that have been edited, and will skip non-edited SmartForm pages. [View Image]

Issuing Department Approval

Once you have requested and reviewed all necessary changes, you may issue department approval. Navigate to the main study workspace and select “Issue Departmental Approval.” In the pop-up window, check all the required boxes to affirm that you reviewed the corresponding item. Enter any additional comments in the text box (not required), and click “OK.” Once “OK” is clicked, the study will have department approval, and will be routed to the IRB for review. [View Image]Categories IRB Education and Training
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