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Export query details

In CTMS, the Query Report feature is a comprehensive summary used by data managers (DM) and clinical research coordinators (CRC) to follow query status data collected from various sources in CTMS and pulled from EDC.

For your convenience, all the available reports can be exported to your computer and analyzed offline or shared with third parties.

To export the query details

  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, expand Query Report.

  3. From the list of reports, select the one you want to export:

    • Query Aging Summary: the report provides a comprehensive summary of query aging—for how long the queries remain in their respective statuses—depicted in statistical charts.

    • Manual Query Details: the report is built based on EDC data and helps to explore the manually created queries and their details, such as level, status, topic, overdue state, replies, users addressing them, and so on.

    • System Query Details: the report is built based on EDC data and displays all the queries automatically created by the system and their details, such as query status, topic, overdue, replies, users addressing them, and more.

    • All Query Report: the report is built based on EDC data and displays the manually and system-created queries and their details, such as query level, status, topic, overdue, replies, users addressing them, and others.

    • PD Queries: the report comprises all queries opened for protocol deviation records in CTMS.

    • Trip Report Queries: the report comprises all queries opened for completed trip reports in CTMS.

    • ICF Tracking Log Queries: the report comprises all queries opened for ICF tracking log records in CTMS.

    • Action Item Queries: the report displays all the queries opened on an action item data including the query description, its corresponding action item, and the details of when and by whom the query is opened.

  4. On the report page that opens, from the workspace toolbar, select Export export_icon.png.

    Exporting query details
    Figure 3. Exporting query details

    Important

    For PD Queries, Trip Report Queries, and ICF Tracking Log Queries reports, at this point, the exported XLSX file is downloaded to your computer and can be used offline as needed.

  5. Based on the query report you are exporting, the next step can be the following:

Once the needed action is performed, the query details report of your interest is downloaded to your computer in the XLSX format and can be used as required.

In this section:

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.

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.

In CTMS, an instance created to address issues or discrepancies discovered during a monitoring visit. One issue may have several action items associated with it because a resolution of a single issue may require several steps.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.