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View all queries report

The All Query Report table displays all the manual and system-created queries per visit, form, item, and record. The report includes data on the query status, topic, due or overdue, replies, users addressing them, inactivation reasons, 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 all queries 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 All Query Report.

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

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

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

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

    All queries report
    Figure 1. All queries report

    Column

    Details

    Record ID

    Represents the unique identifier assigned to the query that remains constant throughout the EDC application.

    Query Level

    Represents the stage at which the query is created, such as Form, Visit, Record, or Item.

    Site Code

    Represents the code of the site to which the visit or form the query belongs.

    Site Name

    Represents the name of the site to which the visit or form 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 unique identifier of the subject under which the query is created for a particular visit, form, record, or item.

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

    Visit Name

    Represents the name of the visit for which the query has been created.

    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 data entry that is questioned by the query.

    Type

    Represents the type of the query—System or Manual.

    Query Topic

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

    Queried By

    Represents the following based on the query type:

    • For Manual queries, represents the name of the system user who opened the query.

    • For System queries, the value is always DM 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 following based on the query type:

    • For Manual queries, represents the role of the system user who opened the query, such as CRC, CRA, PI, or else.

    • For System queries, the value is always DM because all system queries by default are considered as created by the 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:

In eClinical, queries are created to ask a question or get feedback from a designated system user on a particular data item. There are two types of queries in the system:

  • Manual query: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System query: these are generated automatically by the system and require user interaction to manage and resolve them.

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.

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

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.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.