Monitoring report

Monitoring report – is a document generated by monitors (or clinical research associates) during the monitoring process of a clinical trial site.

Definitions

ICH E6(R2)

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 .

Monitoring report contents

Monitoring report provides a detailed summary of the monitor’s findings and observations during 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