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 of 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.
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.
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.
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:
- 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, they may define a mask of “[A-Za-z][-A-Za-z][A-Za-z]” for Initials. When characters in the field are outside of the defined mask, Vault creates a system query.
- 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.
Clinical programmers can define additional data validation rules in Studio. Based on those rules, Vault EDC can create additional system-generated queries.
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.
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.
- 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.
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.
- 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.
Query Rules in EDC Tools
You can manage your query-type Rules from the EDC Tools > Query Rules tab. In the Query Rules tab, you can view details about a rule and activate or inactivate it. From the Jobs tab, 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 Query Rules in EDC Tools for details.
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 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||Open Query||
Ability to create new (open) queries
|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.
Users with the Vault Owner, EDC Lead Data Manager, EDC CRA, or EDC Lead CRA security profiles are automatically able to perform the actions described above.
If your vault uses custom security profiles, you must have the following permissions:
|Security Profile||Tabs: Review||Ability to access the Review tab.|
|Security Profile||EDC: Queries: Answer Query||Ability to answer open Queries.|
|Security Profile||EDC: Queries: Close Query||Ability to close answered Queries.|
Learn more about permission sets.