Performing Actions on Listings

You can perform various actions on data listings, including opening, responding to, and closing queries, as well as setting and managing review statuses in Review Listings. Responding to and closing queries can also be done in query listings.

Prerequisites

Required Permissions

Users with the CDMS Lead Data Manager and CDMS Data Manager standard study roles can perform the actions described below automatically. If your organization uses custom Study Roles, your role must grant the permissions listed in the table below.

Users with the CDB Data Provider study role, or roles based on it, must have access assigned to listings by Source from Admin > Users, in order to answer non-EDC queries for a given data source.

Type Permission Label Controls
Standard Tab Workbench Tab

Ability to access and use the Data Workbench application, via the Workbench tab
Functional Permission Open Query

Ability to create new (open) queries and comment on queries without moving them into the Answered status
Functional Permission Close Query

Ability to close queries
Functional Permission Answer 3rd Party Queries

Ability to answer queries on third party data items in Workbench
Functional Permission View All CDB Query Listings

Ability to view all query listings
Functional Permission View All Listings

Ability to view all listings
Functional Permission API Access

Ability to access and use the Vault EDC API. (This permission is also required to use CDB.)

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Availability: Clinical DataBase (CDB) is only available to CDB license holders. Contact your Veeva Services representative for details.

Query Actions

Queries are used to track inquiries into entered data for Items and Event Dates. Query actions of opening, responding to, and closing queries can be performed either individually or in batches. The batch option allows action on up to 100 queries simultaneously. For example, 100 queries can be generated in a batch containing the same query text.

The following items are eligible for query actions:

  • EDC Event Dates
  • EDC Form Items
  • Non-EDC Form Items

You can’t create, respond to, or close queries on locked form Items or Event Dates.

When performing query actions, you can select any cell that references a single Event Date or Form Item, including those that are part of a univariate function (for example, date format, union, and subquery). Queries are associated with the referenced Event Date or Form Item.

If a cell references more than one Item or Event Date, or doesn’t reference either, the cell details panel will not open.

Opening a Query

In data listings, you can open a new query from the Cell Details panel to create queries on Event Dates and EDC Items.

To open a query:

  1. Navigate to the listing.
  2. Click the Cell where you want to open a query.
  3. Click Create Query.

  4. Enter a comment in the text field. Create Query

  5. Click Save.

To open multiple queries in a batch action from a data listing:

  1. Navigate to the listing.
  2. Select the Checkboxes for the rows you want to query.
  3. Optional: To select all rows on the current page, select the Select All checkbox.
    Select All checkbox
  4. Click Create Query .
  5. Enter a Query Message.
  6. Click Submit.

Use CDB Checks to automatically create and close queries based on a defined set of criteria.

Responding to a Query

You can respond to queries on EDC and third party data with a comment. Your response displays in the Query Details and Cell Details panel, as well as the Last Message column of the listing. Query messages are displayed in chronological order, from oldest to newest.

To respond to a query:

  1. Navigate to the listing.
  2. Click the Cell for the Item containing the query.
  3. Enter a comment.
  4. Click Reply. Reply button

The system adds your query message to the query.

Query Status: When a user with Open Query permission responds to a query, the query status updates to Open. If a user only has the Answer Query permission (i.e., not Open Query permission), the query status is set to Answered. In other words, responses from Data Managers always set the query status to Open, while responses from Site users set the query status to Answered.

Closing a Query

Once a system or manual query is resolved, you can close queries on EDC and third party data from the Cell Details panel. Note that you can’t close a query when the related data Item or Event Date is locked.

To manually close a query:

  1. Navigate to the listing.
  2. Click the Cell for the Item on which you want to close a query.
  3. Optional: Enter a comment.
  4. Click Close. Close button

To close multiple queries in a batch action from a data listing:

  1. Navigate to the listing.
  2. Select the Checkboxes for the rows containing queries you want to close.
  3. Optional: To select all rows on the current page, select the Select All checkbox.
    Select All checkbox
  4. Click Close Query . This opens the Close Query panel.
    Close Query button
  5. For Close Query on, select either the Event Date or the Item that you want to close queries on.
    Close Query on
  6. Optional: Enter a query message in Message Details.
  7. Click Close.

The system can automatically close queries created by EDC Rules or CDB Checks based on a defined set of criteria.

Review Listings

All query actions can also be performed in Review Listings, which provide an additional layer of query review. You can set and view record statuses and provide reasons for each status. A row’s status can be set individually or in batches and filtered by review and query status. Statuses include In Progress, Reviewed, Unreviewed or as having a Known Discrepancy.