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Mark monitoring visit as final

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.

After completing a trip report and signing it with the electronic signature, the phase of the monitoring visit changes to Trip Report Signed. Once a trip report has been reviewed and signed, a monitoring visit can be closed. This means that all visit activities have finished and all observations and discovered findings have been reported so the monitoring visit can be marked as final.

To mark a monitoring visit as final

  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. In the Monitoring Visit table that appears, next to the monitoring visit that you want to mark as final, select More icon_more_actions.png > Final final_trip_report_icon.png.

    Marking monitoring visit as final
    Figure 3. Marking monitoring visit as final

Once confirmed, a monitoring visit becomes marked as final. You can now proceed to adding issues.

Tip

If you want to revert your action, next to the finalized monitoring visit, select More icon_more_actions.png > Cancel Final cancel_final_trip_report_icon.png.

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.