Performing SDV & DMR in the Data Entry Tab


Data managers can perform data management review (DMR) to ensure that data collection follows study protocols. Source data verification (SDV) is to ensure that any data collected is accurate. SDV involves manually comparing the data value on a source data to data entered into Vault EDC.

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 to Not Available. SDV and DMR is required for all Forms and Items in your Study.

The SDV actions described below are available to the EDC CRA and EDC Lead CRA security profiles., while DMR actions are available to the EDC Data Manager and EDC Lead Data Manager security profiles.

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

For Studies created after the 19R3 release, Vault CDMS no longer supports performing SDV or DMR from the Data Entry tab. Use the Review tab to perform your reviews.

Performing DMR & SDV

You can perform DMR and SDV at the Item or Item Group level. Following completed DMR or SDV, if there are any saved data changes, Vault EDC resets DMR and SDV on the item. You can perform DMR or SDV at the Item level by clicking the SDV or DMR icon (details below). Clicking the icon indicates that you have completed SDV or DMR for that Item.

You can perform DMR or SDV at the Item Group level by clicking the SDV or DMR link in the Item Group header. Clicking the link indicates that you have completed SDV or DMR for all Items in the Item Group.

Vault also displays a percentage of DMR and SDV completed on each Form. Note that this percentage is based only on Required items. Optional items are not included.

Percentage Complete for Required SDV and DMR Items

Form Level

You can perform DMR or SDV at the Form level by clicking the icon and selecting Complete All. This indicates that you have completed SDV or DMR for all Items on that Form.

Complete All option

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.

To clear SDV or DMR for an entire Form, click the icon and select Clear All.

Clear All option

SDV & DMR Icons

Icon Meaning
DMR SDV
Unchecked DMR Icon Unchecked SDV Icon An unchecked DMR or SDV icon indicates that DMR or SDV is optional for the Item but is not complete.
Unchecked & Required DMR Icon Unchecked & Required SDV Icon An unchecked icon that is bolded and shaded indicates that DMR or SDV is required for the Item.
Completed DMR Icon Completed SDV Icon A checked icon indicates that DMR or SDV is complete.
Unavailable DMR Icon Unavailable SDV Icon An unchecked, disabled icon indicates that DMR or SDV is unavailable and was not completed.
Unavailable Completed DMR Icon Unavailable Completed SDV Icon An unchecked, disabled icon indicates that DMR or SDV is complete but unavailable. DMR or SDV status cannot be cleared.

Admin: Configuring DMR

SDV and DMR are automatically available in each Study, a user with the Vault Owner permission must create a Review Plan.

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 Data Entry 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 Data Entry Tab

Ability to access the Data Entry 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

In Vault EDC, DMR and SDV are controlled by field-level security. There are two fields on the Item object, Review for SDV and Review for DMR, that performing SDV or DMR edits.

To perform SDV or DMR, you must have edit access to the Review for SDV or Review for DMR field on the Item object.


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