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Activate/Inactivate monitoring visit

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.

It may happen that some old monitoring visit entities are temporarily not required and you need to have a new one designed and active. For this reason, you can leave the most recent monitoring visit entities active and the old ones inactive.

To activate or deactivate a monitoring visit

  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, select Inactivate inactivate_icon.png next to the active monitoring visit in order to deactivate it. Or select Activate activate_icon.png next to the inactive monitoring visit in order to activate it.

    Activating/Inactivating monitoring visit
    Figure 3. Activating/Inactivating monitoring visit

  4. In the Reason dialog that opens, enter the reason for deactivation or activation and then select save_button.png.

    Entering reason to inactivate monitoring visit
    Figure 4. Entering reason to inactivate monitoring visit

Once done, the monitoring visit is deactivated or activated.

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.