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Approve 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 verifies that the study is conducted in compliance with relevant regulatory requirements and GCP guidelines.

In CTMS, for each monitoring visit created in the system, it is individually set whether this visit requires approval of a certain role or a specific person. If the approval is necessary, the system creates a new approval task for assigned users or user roles upon creation, and then each time any edits are introduced to this visit. If you are responsible for approval of a monitoring visit, a respective task is assigned to you in the system.

There are several ways to access monitoring visit approval tasks—from the My Work dashboard or from the Monitoring Visits list.

To approve 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 page that opens, perform one of the following actions:

    • On the My Work dashboard select the Monitoring Visit tile to start working on monitoring visit tasks.

      Accessing monitoring visit tasks
      Figure 3. Accessing monitoring visit tasks

    • In the left pane, select Monitoring > Monitoring Visit and from the table that appears, locate and select the name of the monitoring visit you want to approve.

      Accessing monitoring visit from list
      Figure 4. Accessing monitoring visit from list

  3. On the page that opens, from the monitoring visit configuration form, select approve_button.png.

    Approving monitoring visit
    Figure 5. Approving monitoring visit

The monitoring visit is now approved.

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.