Answering Queries


Once you have submitted a form, Vault, a Clinical Research Associate (CRA), or a Data Manager may open a query on a value. A query indicates that a value may be incorrect or require further explanation.

Types of Queries

Vault EDC has two types of queries: system and manual.

A system query is an edit check, run by Vault EDC. Vault creates system queries based on configured data validation rules in your Study. For example, the system would create a query on a value that was outside of the defined acceptable range. If you update your data to a value that’s in range, Vault automatically closes the query for you.

A manual query is a Query record that a CRA or Data Manager creates. Once you respond and perform any updates, a CRA or Data Manager will review your response and close the query.

Viewing Queries

You can most easily view a list of all open queries using the task bar. The task bar can display a list of open queries at the study, site, or casebook level (if you only have access to one Study and one Site, you can only see site and casebook-level lists. From the task bar, you can click on a query to open it in the Casebook (for Event Date queries) or Form (for Item queries) containing it.

Queries on Event Dates

Vault displays queries on Event Dates in the casebook schedule.

Open query on an Event Date in the casebook schedule

Queries on Items

Vault displays the query next to the queried Item. Vault also displays the Open Query badge on the form’s status icon in the casebook schedule and form carousel.

When viewing the queried Item, you can answer the query.

Open query on an Item

Queries in Repeating Item Group Tabular View

Depending on your study design, your casebooks may include a repeating Item Group in tabular view.

Vault displays open queries differently in this view. If there is a query on an Item in your repeating Item Group, and that Item Group uses tabular view, you’ll see the Open Query icon in the table.

Open Query icon in a repeating Item Group

Once you click the Open Query icon, Vault opens the query in the Query dialog. If there is more than one query on the Item, Vault displays all queries in the Query dialog. From here, you can answer the query.

How to Answer a Query

Once Vault, a CRA, or a Data Manager creates a query on one of your Events, Forms, or Items, the query appears in your task bar. Queries are also counted in the # Site Tasks column on your site listing page.  

Note that if Vault created a system query for a data entry error, correcting the data and saving may automatically close the query, without you having to answer it.

To answer a query:

  1. Navigate to the EventForm, or Item on which there is an open query.
  2. Click the Open Query icon.
  3. Click Reply (for manual queries) or Comment (for system queries).
  4. Optional: For Event-level queries, click Edit Date to enter a new date and select a change reason. 
    • If the query was system-generated, Vault closes the query after you update the date and that date passes the edit check.
    • If the query was manually created, a CRA or Data Manager will close the query after reviewing your reply and changes.
  5. Optional: For Item-level queries, click Edit Value to edit the Item field value within the context of query response. This is only available when the form containing the queried Item is In Progress.
    • If the query was system-generated, Vault closes the query after you update the value and that value passes the edit check.
    • If the query was manually created, a CRA or Data Manager will close the query after reviewing your reply and changes.
  6. Enter a comment.
  7. Click Save.
  8. Perform actions specified in the query.

A CRA or Data Manager will close the query after reviewing your reply and any changes you make to the queried data.

Query Statuses

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.

Status Icon Meaning
Open Open Query Badge Open indicates that a query has not been answered. The Open Query badge icon displays in the casebook schedule on the queried event or form's existing status icon. Vault lists open queries in the task bar.
Answered Answered Query Badge Answered indicates that a query has been addressed. For example, the site has responded with a reason for the queried value. The Answered Query badge icon appears in the casebook schedule on the queried Event or Form’s existing status icon.
Closed N/A Closed indicates that a query requires no further action or discussion. A CRA or Data Manager can reopen a closed query if needed.

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 Principal Investigator, CDMS Sub Investigator, and CDMS Clinical Research Coordinator application roles can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission Data Entry Tab

Ability to access the Data Entry tab

Functional Permission Answer Query

Ability to answer queries

Learn more about Study Roles.

Profile Permissions

These actions are available for the EDC Clinical Research Coordinator and EDC Investigator security profiles.

If your vault uses custom security profiles, you must have the following permissions:

Type Label Controls
Security Profile EDC: Answer Query Ability to answer Open queries
Security Profile Objects: Event: View, Edit Ability to view and edit the queried Event
Security Profile Objects: Form: View, Edit Ability to view and edit the queried Form
Security Profile Objects: Item: View, Edit Ability to view and edit the queried Item

Learn more about permission sets.


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