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Review system query details

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.

However, there are also system-generated queries that are opened automatically when the entered data does not fall under the predefined values. Similar to manually created queries, system queries require user interaction because they need to be addressed and resolved promptly. Thus, it becomes handy to have a comprehensive report to track query statuses, resolution rates, and other details.

In CTMS, the System Query Details report is similar to the System Query Details 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.

Tip

You can also export the query details if you prefer to work with the data offline.

To review the system 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, select Query Report > Manual Query Details.

  3. On the System Query Details page, you can view the statistical data pulled from the EDC system on all available system queries. This statistical data is explained in the following table.

    Important

    Turn the Show Activated Data toggle on/off for your report to exclude/include the data on queries that belong to inactivated forms.

    Reviewing system queries
    Figure 3. Reviewing system queries

    Column

    Details

    Record ID

    Represents the unique identifier of the query record in the system.

    Site Code

    Represents the code of the site where the data that triggered a system query creation has been collected.

    Subject ID

    Represents the ID of the subject to whose data the generated system query is related.

    Visit Name

    Represents the name of the visit during which the data being queried has been collected.

    Form Name

    Represents the CRF name on which the system query has been generated.

    Question

    Represents the question text on the CRF to which the generated system query is related.

    Variable

    Represents the CDASH variable in the source standard to which the generated system query is related.

    Query Topic

    Represents the topic of the generated system query. The query topic usually explains the reason why the query has been added in the first place.

    Queried By

    Represents the name of the user role which facilitated the generation of a corresponding system query.

    Creation Date

    Represents the date when the system query has been opened.

    Query Age (days)

    Represents the total number of days since a corresponding system query has been opened.

    Assigned To

    Represents the name of the user role responsible for the resolution of the generated system query.

    Status

    Represents either the Open or Closed status of the generated system query.

    Overdue

    Represents whether the generated system query is overdue or not.

    Final Reply Text

    Represents the response text of the responsible user to the generated system query.

    Final Reply Date

    Represents the date when the responsible user has responded to the generated system query.

    Final Reply By

    Represents the name of the responsible user who has responded to the generated system query.

    Closed By

    Represents the name of the user who has resolved the system query and closed it.

    Closed Date

    Represents the date when the system query has been closed.

You have reviewed the details of all manually created queries from EDC.

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.