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Review action item queries

In CTMS, you can review and analyze all the queries opened on an action item data to raise questions, request clarification, or highlight concerns related to the information entered. This can help data managers (DM) and clinical research coordinators (CRC) to carefully analyze the queries generated during the monitoring visit process.

To review the action item queries

  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 > Action Item Queries.

  3. On the Action Item Queries page that opens, review the details of all the queries opened on the action items of a monitoring visit. The details of all the report columns are explained in the following table.

    Reviewing action item queries
    Figure 3. Reviewing action item queries

    Column

    Details

    Site Code

    Represents the code of the site where the data being queried has been collected.

    ID

    Represents the ID of the action item.

    Description of Action Item

    Represents the meaningful description of the corresponding action item.

    Question

    Represents whether the action item is assigned to a role (Role Category) or a specific user (Assign to).

    Query Topic

    Displays the question or concern regarding the action item.

    Creation Role

    Represents the role of the user who created the corresponding query.

    Query by

    Represents the user account of the user who created the query.

    Creation Time

    Represents the time when the query was created.

    Creation Query Age (days)

    Represents the number of days since the query was created.

    Query Age (days)

    Represents the number of days since the query was assigned to the responsible user.

    Assign to

    Represents whether the query is assigned to Role or Assignee.

    Role

    Represents the role of the user who is responsible for the resolution of the query.

    Assignee

    Represents the name of the user who is dealing with the action item raised in the query.

    Query Status

    Represents the current status of the action item query.

    Overdue

    Represents whether the action item query is overdue or not.

    Final Reply Text

    Represents the last response text of the responsible user of the query.

    Final Reply Time

    Represents the date and time at which the last response is added by the responsible user of the query.

    Final Reply by

    Represents the name of the user who last responded to the query.

    Closed Time

    Represents the time when the query was closed.

    Closed by

    Represents the name of the user who closed the query.

You have reviewed the details of all action item queries in CTMS.

In this section:

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.

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.