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View system query details report

The System Query Details report displays all the queries per each form item automatically created by the system. The report includes data on query status, topic, due/overdue, replies, users addressing them, and other useful details.

Tip

The query details in the report are provided in the site's primary language—which can differ from the study language—as the site's primary language is the original language of data entry and record keeping.

To view the system query details report

  1. In the EDC application header, select the REPORTS tab.

  2. On the page that opens, in the left pane, select the Query Report subtab to expand the list of available reports and select System Query Details.

  3. On the System Query Details page, you can adjust your report data with the following options:

    • Display Site Name: turn this toggle on/off to show/hide the Site Name column in your report.

    • Only show activated data: turn this toggle on/off for your report to exclude/include the data on queries that belong to inactivated forms.

  4. In the resulting report, review the system query details as explained in the following table.

    System query details report
    Figure 1. System query details report

    Column

    Details

    Record ID

    Represents the unique identifier assigned to a form record in which the query resides.

    Site Code

    Represents the code of the site to which the form with the query belongs.

    Site Name

    Represents the name of the site to which the form with the query belongs. The value for the site name is pulled from CTMS.

    This column is only available if the Display Site Name toggle is turned on.

    [Unique ID Label]

    Represents the ID of the subject to whom the form with the query belongs.

    The column name depends on the unique ID label configuration of your study in IWRS.

    Visit Name

    Represents the name of the visit to which the form with the query belongs.

    Form Name

    Represents the name of the form in which the query resides.

    Record SN

    Represents the serial number (SN) of a form record in which the query resides.

    Question

    Represents the question in the form for the value of which the query is opened.

    Variable

    Represents the name of the form variable for the value of which the query is opened.

    Value

    Represents the value (data entry) that is questioned by the query.

    Query Topic

    Represents the topic (inquiry text) of the query that is also an active link. Selecting this link redirects you to the form hosting the query with the query panel enabled for your review and interaction.

    Queried By

    Represents the DM value because all system queries by default are considered as created by the data manager (DM).

    Owner Role

    Represents the user role currently responsible for query handling in the EDC system.

    This is needed in the case that during the study, the sponsor decides to change the role in charge of query handling in the system. Then, the Creation Role value remains as is, but the owner role reflects the new role assigned to query management.

    For instance, the user role that has been responsible for opening queries in EDC is "DM_001." Then the sponsor decided, that the users of the role "DM_002" must be in charge of query creation. Now in the report, you can see that Creation Role is "DM_001," however, Owner Role is "DM_002."

    Creation Role

    Represents the DM value because all system queries by default are considered as created by the data manager (DM).

    Creation Date

    Represents the date when the query was opened.

    Query Age (days)

    Represents the age of the query—for how many days the query is open and active before it is resolved. The query age can be different from the period passed from the creation date if, for some time, the form to which it belongs was inactivated. The query aging is only calculated when the form is active.

    Assigned To

    Represents the user role to whom the query is assigned.

    Pending Action From

    Represents the user role who has to review and update the value questioned by the query.

    Status

    Represents the current query status: Open, Answered, Closed, or Paused.

    Overdue

    Represents whether the query has passed its due date (Yes) or not (No).

    Final Reply Text

    Represents the text of the last reply added to the query.

    Final Reply Date

    Represents the date and time when the last reply was added to the query.

    Final Reply By

    Represents the name of the system user who added the last reply to the query.

    Closed By

    Represents the name of the user who closed the query.

    Closed Date

    Represents the date and time when the query was closed.

Once the report details are studied, you can leave the page or perform other suggested manipulations.

See also
In this section:
CTMS

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

Get to know all the possibilities of the app with the comprehensive IWRS User Guide.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.