Skip to main content

Edit 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. You can update the configuration of existing monitoring visits if needed.

Important

Only the monitoring visit owner can edit their visit details. The monitoring visits owned by other users can only be viewed in the read-only mode.

To edit 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, next to the needed monitoring visit, select Edit pencil_icon_gray.png.

    Accessing option to edit monitoring visit
    Figure 3. Accessing option to edit monitoring visit

  4. On the page that opens, update the monitoring visit at the following steps:

    Editing monitoring visit
    Figure 4. Editing monitoring visit

Once done, the monitoring visit is updated.

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.