There are two types of queries in Vault EDC: system and manual queries. Vault generates system queries by running checks on 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 a certain range. Manual queries are those created by a Clinical Research Associate (CRA) or Data Manager.
For query information specific to Clinical Research Coordinators (CRCs) and Principal Investigators, see Answering Queries.
Users with the standard CDMS Clinical Research Associate, CDMS Data Manager, and CDMS Lead Data Manager study roles can perform the actions described above by default. If your vault uses custom Study Roles, your role must have the following permissions:
|Standard Tab||Review Tab||
Ability to access the Review 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
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
Answering Queries: If you have the Open Queries permission, commenting on a query will not move it into the Answered status.
From Review > My Studies > Queries, you can see a listing of all queries, including Event Date queries, from Sites that you have permission to access. Vault lists totals of queries by status at the Site and Subject levels, in the Open Queries and Answered Queries columns. See below for details about those statuses.
Click to open a query. Vault automatically opens the Form or Event that the query is on. From here, you can comment on or close the query.
Note that if an Item with an open query is hidden in Data Entry, review users can only close the query, not comment on it.
If your study uses the Team Query Restrictions feature, only members of the same team as the query creator can close a query. If a query is created by one team, for example, the Clinical team, then only members of that team can close the query. In this example, a member of the Data Management team would be able to comment on the query, but that user wouldn’t be able to close it. You can still view and comment on queries created by other teams. Users can choose which Query Team to assign to System queries in Studio > Settings when Team Query Restrictions are enabled.
Each query has a badge indicating which team created it.
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:
- Required: When creating an Item Definition, a study designer can choose to mark a field as required. 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.).
- Future Date (Event Dates): When creating an Event Definition, a study designer can indicate that future dates aren’t allowed. Vault can then create a system query on any Event Date that is later than the current date when entered.
- Out of Window (Event Dates): When creating an Event Definition, a study designer can create a window of allowed dates for an Event. If configured, Vault can create a system query any time an Event Date falls outside of this window.
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 EDC can create additional system-generated queries.
When a system query is manually closed, that same system query will not re-fire when forms are resubmitted.
If you have the View Query Rules permission, and you are able to access the EDC Tools area, you can view a list of all data validation rules for queries in EDC Tools > Query Rules.
Opening Manual Queries
You can open queries from a Form in the Review tab. To open a query in the Reviews tab:
- From the Review tab, navigate to the Form or Item you want to open a query on.
For Event Date queries, click the Open Query icon on the Event Date.
- Click Save. Vault creates the query.
Your new query now displays to data entry users as an Open query that they need to answer. This query also displays in the Queries listing in the Review tab.
Querying Read-only Items: Vault doesn’t allow you to open manual queries against read-only Items.
Commenting on a Query
You can comment on a query.
- Navigate to the Event, Form, or Item on which there is an open query.
- Click the Open Query icon.
- Click Reply (for manual queries) or Comment (for system queries).
- Enter a comment.
- Click Save.
Commenting on a query will only move it to the Answered status if you have the Answer Query permisssion.
Commenting on Queries against Read-only Items: Vault doesn’t allow you to comment on system-generated queries against read-only Items.
Once a system or manual query is resolved, and no further actions are required, you can close a query. Note that you can immediately close a query you create, without a user answering the query.
Vault automatically closes system queries if a user updates the value to value that passes the associated edit check.
- Navigate to the open query. The Answered Query icon indicates that the query was answered.
- Optional: Enter a comment.
- Click Close Query.
You can reopen a manual query if additional action or discussion is required. Note that you may only reopen queries with three (3) or more comments.
To reopen a query:
- Navigate to the closed query.
- Click Reopen.
- Enter a comment.
Vault returns the query to the Open status.
Query Statuses & Icons
Queries in Vault have three statuses: Open, Answered, and Closed. These statuses indicate which actions have been taken and what still needs to occur on a query.
Vault displays the badge icons on top of the Event or Form status icons. Vault then displays the full status icon for queries in the query itself.
Query Rules in EDC Tools
Lead data managers and other users with access to the EDC Tools area can perform additional actions on rules there:
- In EDC Tools > Rules, you can view details about a rule, including its expression.
- In EDC Tools > Jobs, you can initiate a job that evaluates user-entered data against one or multiple query-type Rules, without waiting for a data-entry user to complete a Form. You can also choose to preview the results of that job before initiating it.
See Managing Rules for details.