Querying Data in Data Workbench


Vault CDMS uses “queries” to track inquiry into entered data (for data Items and Event Dates) that is missing, out of range, or otherwise questionable. In Vault EDC, there are two types of queries: system and manual queries. Vault generates system queries by running checks on user-entered data and creating a query when data doesn’t meet specifications defined during study design. For example, Vault creates a system query when an entered date is outside of a certain range. Manual queries are those created by a clinical research associate (CRA), a data manager, or a clinical coder.

In Data Workbench, you can view queries, respond to any existing queries with a comment, and close any queries that don’t require any further action.

In the current release, Vault Data Workbench is only available to specific early adopter customers. Contact your Veeva Services representative for details.

Viewing Queries in Workbench

To view queries in Data Workbench, select a Study, and then navigate to the Queries page, either using the Study menu or the Navigation Drawer.

Queries from the Navigation Drawer
Queries from the Navigation Drawer
Queries from the Study menu
Queries from the Study menu

By default, the Queries page opens to show Outstanding queries, which are queries that are in the Opened, Answered, or Reopened statuses. To view closed queries, click Closed.

Outstanding or Closed selector

Query Statuses

Queries in Vault CDMS have three (3) statuses: Open, Answered, and Closed. These statuses indicate which actions have been taken and what still needs to occur on a query.

Status Meaning
Open Open indicates that a query has not been addressed. This is the status assigned to all newly created queries.
Answered Answered indicates that a query has been addressed. For example, the site has responded with the reason that the queried value is out of range.
Closed Closed indicates that a query requires no further action or discussion. A CRA or data manager can reopen a closed query in Vault EDC if needed.

Syncing Query Statuses with EDC

Vault updates the Query Status of a query to match EDC whenever you click to view that query in Workbench’s Query Details panel. Vault also updates queries and imports any newly created queries from EDC during the Workbench Export job and subsequent import in Workbench, which typically runs each night.

If you have an open query in Workbench, and a Vault EDC user has answered the query since the last time you viewed that query in the Query Details panel (but before the next import run), Workbench updates the query’s status to Answered when you view that query’s details in Workbench.

Responding to a Query

You can respond to queries on execution data with a comment. Note that you can’t respond to queries when the related data Item or Event Date is locked.

To respond to a query:

  1. Navigate to your Study in Queries > Outstanding.
  2. Click a Query to view it in the Query Details panel. Query Details panel

  3. Enter your query response.
  4. Click Reply. Reply button

Vault adds your comment to the query. This is visible from the Query Details panel in Data Workbench, as well as on the queried data item or event date Vault EDC.

If the query was in the Answered status, responding to it in Workbench returns it to the Open status.

Closing a Query

Once a system or manual query is resolved, and no further actions are required, you can close a query. Note that you can’t close queries when the related data Item or Event Date is locked.

To close a query:

  1. Navigate to your Study in Queries > Outstanding.
  2. Click a Query to view it in the Query Details panel. Query Details panel

  3. Optional: Enter a comment.
  4. Click Close. Close button

Vault closes the query and moves it from the Outstanding queries list to the Closed queries list. Refresh the page to see this change.

Vault automatically closes system queries if a user updates the value to value that passes the associated edit check.

System Queries

Vault runs a check and creates a system query on any item value that is out of a defined range. That range is defined during study design.

The following system query types are defined automatically:

  • Mandatory: When creating an Item Definition, a study designer can choose to mark a field as mandatory. If this field is left empty when a form is submitted, Vault creates a system query (“This field is required.”).
  • Range: When creating an Item Definition, a study designer can define a range for a field value. If the entered value is outside of that range, Vault creates a system query (“Value is out of range.”). Note that this query type is only for numeric values, not dates.
  • Future Date: When creating an Item Definition, a study designer can disallow future dates. If a user enters a future date, Vault creates a system query (Future dates are not allowed.).
  • Mask: When creating an Item Definition for a text entry field, a study designer can use the Mask field to define acceptable characters. For example, you may define a mask of “[A-Za-z][-A-Za-z][A-Za-z]” for an Initials item. When characters in the field are outside of the defined mask, Vault creates a system query.
Note that Vault does not create queries on disabled Items.

Study designers can define additional data validation rules in Studio. Based on those rules, Vault can create additional system-generated queries.