What is the written report from the monitor to the sponsor after each site visit or other trial-related communication called?

• A. Monitoring
• B. Monitoring Report
• C. Investigator's Brochure
• D. Nonclinical Study

Answer: (D)

In ICH GCP, after each site visit the monitor prepares a formal written report to the sponsor that documents what was reviewed, any deviations or issues found, and recommended corrective actions. This document is called the monitoring report (often referred to as a monitoring visit report). It serves as the official communication and record of monitoring findings.

The term monitoring describes the activity of overseeing the trial, not the written document. An Investigator's Brochure is a compilation of safety and pharmacology data about the investigational product for investigators, and a nonclinical study refers to preclinical research typically conducted in animals or in vitro.