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View canceled manual query report

The Cancelled Manual Query report displays all the canceled manual queries per visit, form, record, and item. The report includes data on the query topic, creator, assignee, cancelation reason, 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 canceled manual query 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 Manual Query Details.

    Accessing manual query details
    Figure 1. Accessing manual query details

  3. On the page that appears, select the Cancelled Manual Query tab.

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

    Reviewing canceled query report
    Figure 2. Reviewing canceled query report

    Column

    Details

    Record ID

    Represents the unique identifier assigned to the canceled query when it was created.

    Query Level

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

    Site Code

    Represents the code of the site to which the case report form (CRF) with the canceled query belongs.

    [Unique ID Label]

    Represents the unique identifier of the subject to whom the CRF with the canceled 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 CRF with the canceled query belongs.

    Form Name

    Represents the name of the CRF in which the canceled query resided.

    Record SN

    Represents the serial number (SN) of a CRF record in which the canceled query resided.

    Question

    Represents the question in the CRF for whose value the canceled query was opened.

    Variable

    Represents the name of the form variable for whose value the canceled query was opened.

    Value

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

    Query Topic

    Represents the topic (inquiry text) of the canceled query.

    Queried By

    Represents the name of the user who opened the query.

    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 role of the user who opened the query, such as CRC, CRA, PI, or else.

    Creation Date

    Represents the date when the query was opened.

    Assigned To

    Represents the role of the user to whom the query was assigned before canceled.

    Status

    Represents the query status at the moment of cancelation.

    Cancelled Reason

    Represents the reason entered by the user upon canceling the query.

    Cancelled Date

    Represents the date and time when the query was canceled.

You have studied the canceled query report details. You can also export this report data to your computer.

Tip

Any of the canceled queries can be restored to their previous location to be addressed by the assignee.

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.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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 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.