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Export 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. The statistical data related to the monitoring visits completion summary can be exported in the XLSX file so you can view it offline on your computer.

To export 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. Above the Monitoring Completion table that appears, from the workspace toolbar, select Export export_icon.png.

    Accessing monitoring completion
    Figure 2. Accessing monitoring completion

    Tip

    If you want to view or download the historic files of the monitoring completion report, then from the workspace toolbar, select Export History export_history_icon.png. In the Export History dialog that opens, next to the file you want to download, select download_icon.png and save it to your computer and use it offline.

    Exporting historic files
    Figure 3. Exporting historic files

Once selected, the monitoring completion report becomes downloaded to your computer. You can then open it to view it offline.

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.