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Monitoring

Monitoring refers to the process of inspecting and managing clinical trial activities within the CTMS system. Using the CTMS system, clinical research associates (CRA) can manage and monitor various aspects of the trial, including recruitment of study visits, collection of study data, and managing study budgets and timelines.

CTMS monitoring facilitates the conduct of the clinical trial in accordance with the sponsor's study operating procedure (SOP), study protocol, and Good Clinical Practice (GCP) guidelines.

The following sections explain various features available in the CTMS application to help you manage and review monitoring activities:

  • Monitoring configuration: specifies features to define and set up the monitoring configurations to facilitate the preparation and management of monitoring visits.

  • Monitoring plan: explains how to create monitoring plans that specify the approach for overseeing clinical trial sites to ensure compliance, data quality, and participant safety.

  • Monitoring visit: describes various tools available to plan, schedule, and track monitoring visits.

  • Issues: defines how you can add, track, and manage issues or discrepancies identified at the site during monitoring visits that require resolution.

  • Action items: explains features available to add, track, and manage any tasks or action items that are associated with the issues identified previously at a site during a monitoring visit.

  • Analyze SDV result and Analyze SDR result: outline the process for reviewing and conducting source data validation (SDV) and source data review (SDR) activities to assess the quality, consistency, and protocol compliance of study data.

  • Monitoring visit summary: specifies how you can assess monitoring activity for your entire study to analyze and get precise statistics on specific visit types, generate the summary by country or site, and more.

  • Trip report addenda: captures any additional notes, clarifications, or updates added after the completion of a monitoring visit report to ensure accurate and comprehensive visit documentation.

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.

An activity in which 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 complies with relevant regulatory requirements and GCP guidelines.

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.