Which term describes the ongoing evaluation of trial progress and subject safety by a monitor, and the reporting of findings to the sponsor?

Which term describes the ongoing evaluation of trial progress and subject safety by a monitor, and the reporting of findings to the sponsor?

• A. Monitoring
• B. Monitoring Report
• C. Investigator
• D. IRB

Answer: (B)

In GCP, oversight of trial progress and subject safety is carried out through monitoring—the ongoing activity of checking that the study is being conducted according to the protocol, standards, and regulations. After monitoring visits, the findings are documented and communicated to the sponsor in a formal report. Because this option specifically denotes the document that captures and conveys those monitoring findings to the sponsor, it best fits the description given: the ongoing evaluation by a monitor and the reporting of what’s found to the sponsor. The investigator is the person at the site conducting the trial, and the IRB is the ethics review board; neither term describes the ongoing oversight coupled with reporting to the sponsor. Monitoring refers to the activity itself, but the term that encapsulates the reporting to the sponsor is the monitoring report.

In GCP, oversight of trial progress and subject safety is carried out through monitoring—the ongoing activity of checking that the study is being conducted according to the protocol, standards, and regulations. After monitoring visits, the findings are documented and communicated to the sponsor in a formal report. Because this option specifically denotes the document that captures and conveys those monitoring findings to the sponsor, it best fits the description given: the ongoing evaluation by a monitor and the reporting of what’s found to the sponsor.

The investigator is the person at the site conducting the trial, and the IRB is the ethics review board; neither term describes the ongoing oversight coupled with reporting to the sponsor. Monitoring refers to the activity itself, but the term that encapsulates the reporting to the sponsor is the monitoring report.