Performing Actions on Listings
You can perform various actions on data listings, including opening, responding to, and closing queries and observations, and setting and managing review statuses in Review Listings. Responding to and closing queries can also be done in query listings.
Prerequisites
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:
- Navigate to the listing.
- Click the Cell where you want to open a query.
- Click Create Query.
- Click Save.
To open multiple queries in a batch action from a data listing:
- Navigate to the listing.
- Select the Checkboxes for the rows you want to query.
- Enter a Query Message.
- 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:
- Navigate to the listing.
- Click the Cell for the Item containing the query.
- Enter a comment.
- Click Reply.
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:
- Navigate to the listing.
- Click the Cell for the Item on which you want to close a query.
- Optional: Enter a comment.
- Click Close.
To close multiple queries in a batch action from a data listing:
- Navigate to the listing.
- Select the Checkboxes for the rows containing queries you want to close.
- Click Close.
The system can automatically close queries created by EDC Rules or CDB Checks based on a defined set of criteria.
Observation Actions
Prerequisites
Users with the CDMS Lead Data Manager, CDMS Data Manager, and CDMS Super User 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 |
---|---|---|
Functional Permission | View Observation | Ability to view observations. |
Functional Permission | Create Observation | Ability to create new observations. |
Functional Permission | Close Observation | Ability to close observations. |
Functional Permission | Reply Observation | Ability to reply to observations and set their status as pending and/or open. |
Before generating a query, discrepancies must be reviewed by the data management team and/or discussed across various teams. Observations allow data managers to collaborate with colleagues before generating queries.
You can create observations on Form Items, single-function Form Items, and Event Dates using EDC or third party data. Observations are visible wherever the Item is displayed, so the observation follows the data in all the listings where the data appears.
You can view, create, respond to, and close observations for Core, Review, and Custom data listings.
An observation decoration appears in each cell that contains at least one associated Open or Pending observation. Observations remain in the listing even if the cell value changes.
When creating an observation, you can choose from the following categories:
- Mismatched
- Out of range
- Unexpected
Observation Statuses
Each observation can have the following (3) statuses: Open, Pending, or Closed. These statuses indicate which actions have been taken and what still needs to occur on an observation. When both Open and Pending statuses are present, the observation is considered outstanding.
Replying to an observation moves it to the Open or Pending status depending on which status you select in the Observations tab.
Observation Decorations
Observations are highlighted with decorations at both the row and cell levels. Row level decorations are located in the Review column. When hovering over a decoration at the row level, a tooltip appears if the record contains at least one open, pending, or outstanding observation (with a status of Open or Pending). A tooltip also appears in the individual cell linked to the observation when hovering over the decoration. Decorations are not displayed for observations in the Closed status, but they are still visible in the details panel.
Creating Observations
You can create an observation individually or in a batch action. Creating an observation moves it to the Open status.
To create an observation individually:
- Navigate to the listing.
-
Choose a category from the dropdown menu (Mismatch, Out of Range, or Unexpected). Your selected category is displayed above the listings.
- Click the Cell where you want to create an observation.
- Click Submit.
To create multiple observations in a batch action:
- Navigate to the listing.
- Click Observations in the upper-right navigation bar.
- Choose a category from the dropdown menu (Mismatch, Out of Range, or Unexpected). Your selected category is displayed above the listings.
- Click Submit.
You can’t create, respond to, or close observations on locked Form Items or Event Dates.
Responding to an Observation
You can respond to an observation in the Observations tab. Responding to an observation changes the status to Open or Pending, depending on your selection.
To respond to an observation:
- Navigate to the listing.
- Click the Cell containing the observation.
- Optional: Set the status of the observation to Open or Pending.
- Enter a message
- Click Save.
Closing an Observation
You can close an observation individually or in a batch action. Closing an observation moves it to the Closed status. Observations can be closed when Open or Pending.
To close an observation individually:
- Navigate to the listing.
- Click the Cell containing the observation.
- Optional: Enter a message.
- Click Save.
To close multiple observations in a batch action:
- Navigate to the listing.
- Click the Cells containing the observation.
- Click Close.
- Optional: Enter a message.
- Click Save.
You can export all observations and observation messages and include them in extracts.
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.