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View canceled lab query report

The Cancelled Manual Query report displays all the canceled lab queries per category—for instance, "Urinalysis," "Hematology," and so on—or lab test. The report includes data on the query topic, creator, assignee, cancelation reason, and other useful details.

To view the canceled lab 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 Lab Query Report.

    Accessing lab query report
    Figure 1. Accessing lab query report

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

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

    Reviewing canceled lab query report
    Figure 2. Reviewing canceled lab query report

    Column

    Details

    Record ID

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

    Site Code

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

    Lab Name

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

    Category

    Represents the category of the lab test for which the canceled query was generated, for instance, Urinalysis.

    Sub-Category

    Represents the subcategory of the lab test data, for instance, the subcategory of LB is Hematology.

    Currently, in the EDC application, the sub-category value is not used. This value is preset for studies that use the domain name (LB, DM, and so on) as a category, then the subcategory is Hematology, Urinalysis, and so on.

    Lab ID

    Represents the unique ID of the lab in which the canceled query resided.

    Lab Test Name

    Represents the name of the laboratory test for which the canceled query was generated, such as Bilirubin, Glucose, and so on.

    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 lab 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 lab 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 lab query report details. You can also export this report data to your computer.

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.

A specific area or category of data within a clinical trial that encompasses a set of related variables that share a common theme. Each domain organizes data to facilitate analysis and reporting, ensuring that information is structured and easily interpretable.

For example, in a clinical trial, domains might include demographics, efficacy, safety, and laboratory results.

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.