During Monitoring Procedures, after each site visit, what must a monitoring report include?

• A. A summary of significant findings, deviations and actions taken
• B. A list of the monitors' personal opinions
• C. The sponsor's marketing plan
• D. The site's patient payment details

Answer: (A)

After a site visit, the monitoring report serves as the formal record of what was observed and how issues were addressed. It should include a concise summary of significant findings, any deviations from the protocol or GCP, and the actions taken to correct problems or prevent recurrence. This creates an auditable trail for the sponsor, informs site oversight, and guides follow-up monitoring and corrective actions. The report should be objective and focused on findings and remediation, not personal opinions. Items like the sponsor’s marketing plan or patient payment details are unrelated to monitoring of trial conduct and should not be included.