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Review query aging summary

A query refers to the request for clarification on some data items collected in EDC on the CRF during a clinical trial. Usually, query requests are posted by data managers (DM) so that clinical research coordinators (CRC) can resolve errors or inconsistencies discovered during the data review. Most of the time, queries are generated automatically by the system when the entered data falls outside the predefined values but they can also be opened manually by data reviewers.

In CTMS, you can review the comprehensive summary of query aging—for how long the queries remain in their respective statuses—depicted in statistical charts. This report is similar to the query aging report in EDC. The data is pulled from EDC to CTMS to facilitate data management and review processes and eliminate the need to switch between applications.

To review the query aging summary

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study management page that opens, from the left pane, select Query Report > Query Aging Summary.

  3. Under the Summary tab that opens, analyze the statistical charts on manual queries. All queries are grouped in different charts by study and site so you can learn about the most current status of those queries separately.

    Analyzing manual query charts
    Figure 3. Analyzing manual query charts

  4. Switch to the Details tab to analyze the aging summary of both system and manual queries as follows:

    • Interval of days: enter the intervals in days based on which you want to generate the charts for system and manual queries and select generate_graph.png.

    • Query Status: select the checkboxes next to the system and manual query statuses that you want to display on the chart: Open, Closed, and Answered.

    • Site Code: select the checkboxes next to the sites for which you want to view the system and manual query statistics.

    Analyzing aging summary charts
    Figure 4. Analyzing aging summary charts

You have reviewed the query aging summary details.

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

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

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

See also eCRF.

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.