Monitoring

Monitoring – is process of overseeing and supervising a clinical trial to ensure that it is conducted according to the study protocol, regulatory requirements, and ethical principles.

Definitions

ICH E6(R2)

1.38 Monitoring:

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) .

1.39 Monitoring Report:

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs .

Role of clinical monitoring

Monitoring activities typically involve regular site visits by monitors (clinical research associates, CRAs) who review study documentation, verify data accuracy, assess participant safety, and ensure compliance with Good clinical practice (GCP) guidelines.

The primary goal of monitoring is to safeguard the rights and well-being of trial participants, and to maintain the integrity and reliability of the trial data.

Monitoring report

Monitoring report – is a document generated by clinical research associates upon the monitoring process of a clinical trial site. Monitoring report provides a detailed summary of the monitor’s findings and observations during on-site visits or remote monitoring activities. It typically includes information on patients’ safety, protocol adherence, study drug management, data integrity, as well as compliance with regulatory requirements and good clinical practice (GCP) guidelines.

See also

Another relevant pages

• Investigator
• Protocol
• Source data
• Sponsor