Managing Queries in the Data Entry Tab
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 Investigators, see Answering Queries.
To view a single query, navigate to the query using the Task Bar (if the query is answered) or by navigating to the queried field. Note that closed queries display below the queried item but not in the Task Bar.
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, you 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, you 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, you 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, you 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 Initials. 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.
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 create a manual query at the Item level. For example, you may create a query to question whether entered data on an Item was transcribed correctly. You can create a manual query on any data that is not locked.
To create a query at the Item level:
- Navigate to the Item you want to query in the Form.
- Enter a comment in the dialog.
- Optional: If the Item is frozen, and will require edits to resolve the query, select the Unfreeze checkbox to unfreeze the Item. If you intend for the site user to make multiple changes on the form, you can unfreeze the entire Form.
- Click Save.
You can also create queries at the Event level. For example, you may create a query to question whether an Event date is correct.
To create a query at the Event level:
- Navigate to the Event you want to query.
- From the Actions menu, select Open Query.
- Enter a comment.
- Click Save.
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, either through the Casebooks tab or the Task Bar. 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||Data Entry Tab||
Ability to access the Data Entry tab
|Functional Permission||Open Query||
Ability to create new (open) queries
|Functional Permission||Close Query||
Ability to close queries
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||EDC: Queries: Answer Query||Ability to answer open Queries.|
|Security Profile||EDC: Queries: Close Query||Ability to close answered Queries.|