Performing SDV & DMR
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.
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 or Site. Sponsors can define which fields require SDV or DMR for a given study or site 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 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.
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:
- From the Review tab, click through to access the abbreviated casebook schedule for a Subject.
- Click to open a Form with incomplete DMR or SDV from the Event & Form List panel.
- To remove SDV or DMR review, click the icon again or click the checkbox to clear it.
- Click the Next SDV Task or Next DMR Task buttons to quickly move to the next open review task.
- 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|
|An unchecked optional DMR or SDV icon indicates that SDV or DMR is optional, but is not complete.|
|A checked optional SDV or DMR icon indicates that DMR or SDV is optional and complete|
|An unchecked icon indicates that SDV or DMR is required.|
|A checked icon indicates that SDV or DMR is required and complete.|
|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:
|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
|Functional Permission||View DMR||
Ability to view DMR status
|Functional Permission||Edit DMR||
Ability to perform DMR
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
If your vault uses custom security profiles, you must have the following permissions to perform these tasks:
|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.|
|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.