Performing SDV

Clinical research associates (CRAs) can perform source data verification (SDV) after a form is submitted to ensure that any data collected by a site is accurate. SDV involves manually comparing data from the source to data entered in Vault EDC. You can perform SDV from within the Review tab. For help with DMR, see Performing DMR.

SDV Requirements

Depending on your vault’s configuration and your study design, you may have only SDV or DMR, or both SDV and DMR for a Study or Site. Sponsors can define which fields require SDV 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. SDV and DMR is required for all Forms and Items in your Study or Site.

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

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

How to Perform SDV

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

SDV an Event

To perform SDV on an entire Event:

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 SDV icon in the Event Header to complete your review.
4. Optional: Click Next SDV Task to quickly move to the next open SDV task.
5. Click Save.

Performing SDV on an Event will apply SDV to the Event Date, Visit Method (if configured), and associated forms.

SDV an Event Date

To perform SDV 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 SDV icon for the Event Date to complete your review.
4. Optional: Click Next SDV Task to quickly move to the next open SDV task.
5. Click Save.

SDV a Form

To perform SDV 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 SDV icon in the Form Header to complete your review.
4. Optional: Click Next SDV Task to quickly move to the next open SDV task.
5. Click Save.

SDV an Item Group

To perform SDV 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 SDV.
4. Click the SDV icon to complete your review.
5. Optional: Click Next SDV Task to quickly move to the next open SDV task.
6. Click Save.

SDV an Item

To perform SDV 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 SDV.
4. Click the SDV icon to complete your review.
5. Optional: Click Next SDV Task to quickly move to the next open SDV task.
6. Click Save.

Completing SDV

Last Updated: 23R1

This video goes over how to complete source data verification (SDV) review in the Review tab of EDC.

Additive Review

From time to time, you may need to perform additional SDV 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 Site 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 SDV. 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.

How to Clear Completed SDV

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

SDV Status Icons

Vault uses these icons to represent SDV review statuses:

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

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