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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.

The CTMS application contains a set of tools to plan, schedule, and track monitoring visits. Before the actual monitoring visit, a monitor can create visits manually or prepare a monitoring plan according to which the visits are scheduled. Each monitoring visit includes information about the trial sites, monitoring content, protocol deviations, and any potential issues or concerns that can be identified at the sites. During the visit, a monitor can use CTMS to document observations, review study data, and communicate visit findings to the study team.

After the visit, the monitor can use the CTMS system to generate trip reports summarizing visit findings and recommendations and tracking follow-up actions. The reports are generated to ensure that any identified issues are addressed in a timely and appropriate manner.

In CTMS, you can access and review the list of all monitoring visits for the study with their necessary details as explained in the following table.

Monitoring visit list
Figure 1. Monitoring visit list

Tip

Turn on the Show My Monitoring Visit toggle to only display the monitoring visits created by you.

Column

Details

Monitoring Visit ID

Represents the unique identifier assigned to the monitoring visit by the system upon creation. This is also a hyperlink you select to access monitoring visit details and perform the following actions:

The red exclamation mark next to the ID indicates that the actual start and end dates of this visit overlap with another monitoring visit. The query symbol means there are queries in the trip report that require attention.

Monitoring Visit Name

Represents a unique name of the monitoring visit entered manually or autogenerated based on the naming convention of the monitoring visit configuration.

Visit Create Method

Represents how the monitoring visit is created in CTMS—manually by users or automatically by the system.

Site Code

Represents a unique identifier of the site for which the monitoring visit is created.

Monitoring Visit Type

Represents the type of monitoring for the created visit: PSSV (Pre-Study Site Visit), SIV (Site Initiation Visit), IMV (Interim Monitoring Visit), or COV (Close Out Visit).

Planned Start Date

Represents the date when the monitoring visit needs to be initiated.

Planned End Date

Represents the date when the monitoring visit needs to finish.

Actual Start Date

Represents the date when the monitoring visit has actually began at the site.

Actual End Date

Represents the date when the monitoring visit has actually ended at the site.

Monitoring Visit Phase

Represents the current state of the monitoring visit: Visit Planned, Visit Changed, Visit Confirmed, Visit Cancelled, Trip Report Initial, Trip Report Data Entry Completed, Trip Report Review Completed, or Final.

Trip Report Status

Represents the current state of the trip report: Submitted or Trip Report Completed.

Created by

Represents the name of the user who has created the monitoring visit in the system.

Monitoring Visit Owner

Represents the name of the user who is indicated as the person in charge who must perform the monitoring visit.

Monitoring Visit Companion

Represents the name of the user who is indicated as the person accompanying the monitoring visit owner in their activities.

Status

Represents the current activation status of the monitoring visit.
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.