Performing SDV & DMR in the Review Tab


Data managers can perform data management review (DMR) to ensure that data collection follows study protocols. Clinical research associates (CRAs) can perform source data verification (SDV) to ensure that any data collected is accurate. SDV involves manually comparing data from the source to data entered into Vault EDC.

This article describes SDV and DMR processes within the Review tab. For details about performing SDV and DMR in the Data Entry tab, see Performing SDV & DMR in the Data Entry Tab.

This feature may not be enabled in your vault. Contact Veeva Support to enable the Review tab.

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

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

Performing SDV & DMR

You can perform SDV or DMR from the Content panel by clicking on the SDV and DMR status icons.The SDV actions described below are available to the CDMS Clinical Research Associate, EDC Lead CRA, and EDC CRA roles. The DMR actions are available to the CDMS Data Manager, CDMS Lead Data Manager, EDC Lead Data Manager, and EDC Data Manager roles. See details about access to SDV and DMR tasks below.

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.

To perform SDV or DMR:

  1. From the Review tab, click through to access the abbreviated casebook schedule for a Subject.
  2. Click to open a Form with incomplete DMR or SDV from the Event & Form List panel.
  3. To complete SDV or DMR at the Event level, click SDV or DMR icon in the Event header. Event-level SDV

  4. To complete SDV or DMR at the Form or Item Group level, click the SDV or DMR icon in the Form or Item Group header. Form-level SDV

  5. To complete SDV or DMR at the Item level, select the SDV or DMR checkboxes to complete SDV or DMR on that Item. Item Group & Item SDV

  6. To remove SDV or DMR review, click the icon again or click the checkbox to clear it.
  7. Click the Next SDV Task or Next DMR Task buttons to quickly move to the next open review task.
  8. When finished, click Save.

You can click Discard changes to remove your review changes since your most recent save.

SDV & DMR Icons

Vault uses these icons to represent SDV and DMR review statuses:

SDV Icon DMR Icon Meaning
SDV Optional Icon DMR Optional Icon An unchecked optional DMR or SDV icon indicates that SDV or DMR is optional, but is not complete.
SDV Optional & Complete Icon DMR Optional & Complete Icon A checked optional SDV or DMR icon indicates that DMR or SDV is optional and complete
SDV Required Icon SDV Required Icon An unchecked icon indicates that SDV or DMR is required.
SDV Required & Complete Icon DMR Required & Complete Icon A checked icon indicates that SDV or DMR is required and complete.
Review Partially Complete Icon Review Partially Complete Icon This icon indicates that SDV or DMR is partially complete. This status rolls up to the Event level. If an Event has three Forms, and only one of those Forms has DMR completed, the Event displays this icon, and the Form displays the DMR complete icon.
No Icon No Icon No icon indicates that SDV or DMR is not required.

Clearing SDV & DMR

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

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard CDMS Clinical Research Associate, and CDMS Data Manager application roles and a Security Profile that grants access to the Review tab can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission 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

Functional Permission View DMR

Ability to view DMR status

Functional Permission Edit DMR

Ability to perform DMR

Learn more about Study Roles.

Profile Permissions

SDV actions are available to the EDC CRA and EDC Lead CRA security profiles. DMR actions are available for the EDC Data Manager and EDC Lead Data Manager security profiles.

If your vault uses custom security profiles, you must have the following permissions to perform these tasks:

Type Permission Controls
SDV
Security Profile Object: Event: Review for SDV: Edit Ability to perform SDV on an Event Date.
Security Profile Object: Form: Review for SDV: Edit Ability to perform SDV on a Form.
Security Profile Object: Item: Review for SDV: Edit Ability to perform SDV on an Item.
DMR
Security Profile Object: Event: Review for DMR: Edit Ability to perform DMR on an Event.
Security Profile Object: Form: Review for DMR: Edit Ability to perform DMR on a Form.
Security Profile Object: Item: Review for DMR: Edit Ability to perform DMR on an Event.

Learn more about permission sets.