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.
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.
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.
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.
SDV & DMR Icons
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:
|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.
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.