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Analyze monitoring completion report

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 verifies that the study is conducted in compliance with relevant regulatory requirements and GCP guidelines. You can view the statistical data on the total number of monitoring visits per study within a single page.

To analyze the monitoring completion report

  1. In the CTMS application header, select the REPORT tab.

  2. On the page that opens, in the left pane, expand Study Quality Control and select Monitoring Completion.

    Accessing monitoring completion
    Figure 1. Accessing monitoring completion

  3. In the Monitoring Completion table that appears, view the list of monitoring visits created for each available study.

    Viewing monitoring completion report
    Figure 2. Viewing monitoring completion report

    Tip

    You can switch the table view to see the list of monitoring visits grouped by study, country/region, or site. Simply select the necessary grouping option from the workspace toolbar above the table.

Once viewed, you can now export the monitoring completion report to your computer if needed.

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.

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