Performing SDV

Clinical research associates (CRAs) can perform source data verification, or SDV, 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.

Prerequisites

Before you can perform SDV on study data, the following configurations are required:

  • A study designer creates at least one Review Plan using the SDV review task.
  • A lead data manager assigns the Review Plan to the Site.

Users with the standard CDMS Clinical Research Associate study role can perform the actions described above by default. If your organization uses custom Study Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab Review Tab

Ability to access the Review tab

Functional Permission View SDV

Ability to view SDV status

Functional Permission Edit SDV

Ability to perform SDV

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


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.

Form in Content panel with partial DMR and SDV reviews

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.

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.

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.