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View monitoring visit versioning history

A monitoring visit refers to an activity when a monitor, usually a clinical research associate (CRA), visits sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also checks that the study is conducted in compliance with relevant regulatory requirements and GCP guidelines. When a new version of the monitor template has been created, you can upgrade trip report templates associated with your monitoring visits so they can include the latest updates. Later you can view the history of all the version changes and pertinent details.

To view the history of a monitoring visit version upgrades

  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 page that opens, in the left pane, expand Monitoring and select Monitoring Visit.

  3. Above the Monitoring Visit table that appears, from the workspace toolbar, select Upgrade Version upgrade_version_icon.png.

    Accessing option to upgrade monitoring visit version
    Figure 3. Accessing option to upgrade monitoring visit version

  4. On the Upgrade Version page that opens, from the workspace toolbar, select Operation History history_icon.png.

    Selecting Operation History option
    Figure 4. Selecting Operation History option

  5. In the Change History dialog that opens, view the history of all the version upgrades and such details as the name of the operator who upgraded the version, their role, time of action, and others.

    Viewing monitoring visit change history
    Figure 5. Viewing monitoring visit change history

  6. Select close_icon_red.png.

You have viewed the operation history of the monitoring visit version upgrades.

In this section:

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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

An international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects.