Performing DMR

Data managers can perform data management review (DMR) after a form is submitted to ensure that data collection follows study protocols. For help with SDV, see Performing SDV.

DMR Requirements

Sponsors can define which items require DMR for a given study or site using Review Plans. See Creating a Review Plan for details. If no Review Plan exists, the Requirement Mode for all Items in your Study or Site is set no review required. DMR is required for all Forms and Items in your Study or Site.

Vault displays the DMR status in the Event & Form List panel.

When you view a Form in the Content panel, you can click the DMR status icons to complete the review.

How to Perform DMR

You can perform DMR or DMR from the Content panel by clicking on the DMR and DMR status icons. As you perform DMR or DMR, Vault highlights the Items with unsaved reviews in yellow. You must click Save for Vault to save your DMR or DMR changes and update the Event and Form review statuses.

DMR an Event Date

To perform DMR on an Event Date:

1. Navigate to the Casebook containing the Event in the Review tab.
2. Click to open the Event you want to review in the Schedule panel.
3. Click the DMR icon for the Event Date to complete your review.
4. Optional: Click Next DMR Task to quickly move to the next open DMR task.
5. Click Save.

DMR a Form

To perform DMR on a whole Form:

1. Navigate to the Casebook containing the Form in the Review tab.
2. Click to open the Form you want to review in the Schedule panel.
3. Click the DMR icon in the Form Header to complete your review.
4. Optional: Click Next DMR Task to quickly move to the next open DMR task.
5. Click Save.

DMR an Item Group

To perform DMR on an Item Group:

1. Navigate to the Casebook containing the Item in the Review tab.
2. Click to open the Form containing the Item Group in the Schedule panel.
3. In the Content panel, locate the Item you want to DMR.
4. Click the DMR icon to complete your review.
5. Optional: Click Next DMR Task to quickly move to the next open DMR task.
6. Click Save.

DMR an Item

To perform DMR on an Item:

1. Navigate to the Casebook containing the Item in the Review tab.
2. Click to open the Form containing the Item in the Schedule panel.
3. In the Content panel, locate the Item you want to DMR.
4. Click the DMR icon to complete your review.
5. Optional: Click Next DMR Task to quickly move to the next open DMR task.
6. Click Save.

Completing DMR

Last Updated: 23R1

This video goes over how to complete data management review (DMR) in the Review tab of EDC.

Additive Review

From time to time, you may need to perform additional DMR on Event Dates or Items where DMR isn’t required by the review plan. You can track these reviews by using Additive Review.

When you turn on Additive Review mode, it turns on for the entire Study and not just for the Casebook being viewed. However, Additive Review is user-specific, meaning that it will only apply to the user who enables it. Once you enter Additive Review mode, Vault remains in Additive Review mode for up to 24 hours, or until you toggle Additive Review mode off.

While Additive Review mode is on, you can perform SDV on any Event Date or Item within the Casebook and record a reason for the review. When you save your reviews, Vault displays a plus () icon. You can hover over that icon to show the Additive Reason.

You can perform additive reviews alongside required and optional SDV.

To perform additive review:

1. Navigate to the Casebook you want to review in the Review tab.

2. Click the Additive Review toggle to turn on Additive Review mode.

3. Select an Additive Reason.

4. Click Save. This starts Additive Review mode.
5. Optional: To change the Additive Reason:
   1. Hover over the Additive Review toggle’s label.

   2. Click Change Additive Reason.

   3. Select a new Additive Reason.
   4. Click Save.
6. Perform the necessary DMR. See instructions for each level of data above.
7. When finished, click Save.

Vault will send you an email with an Additive Review summary that includes the following columns:

• Study
• Country
• Site
• Subject
• Subject Status
• Event Group
• Event Date
• Form Label
• Form Sequence
• Item Group Label
• Item Group Sequence Number
• Item Label
• Review Plan
• Last Reviewed By
• Last Reviewed Date
• Additive Reason
• Last Run of Listing

Additive Review

Last Updated: 23R1

This video shows how to perform additive review in the Review tab.

DMR Icons

Vault uses these icons to represent DMR review statuses:

Icon	Name	Meaning
	DMR Complete	A checked icon indicates that the required DMR is complete
	DMR Optional Complete	A checked icon with “optional” appended indicates that DMR is optional and completed
	DMR Optional	An unchecked icon with “optional” appended indicates that DMR is optional and incomplete
	DMR Required	An unchecked icon indicates that DMR is required and incomplete
No Icon	DMR Not Required	No icon indicates that DMR is not required for the Event, Form, or Item.

In the Event & Form List panel, Vault uses different icons to indicate dmr requiredness and completeness.

Clearing DMR

You can clear DMR to indicate that DMR should be performed again, or has been invalidated. To clear DMR, click the icon or link (for Item Groups) a second time. The icons for each item return to their unchecked state.