What must a monitoring report include after each site visit?

• A. Date, site, name of the monitor, and name of the investigator, plus a summary of significant findings, deviations, deficiencies, and actions taken or planned
• B. Only a list of subjects enrolled
• C. The budget details
• D. The sponsor's competitor data

Answer: (B)

A monitoring report after a site visit should document the visit in a way that supports oversight, accountability, and follow-up. It must include the date of the visit, site, the monitor’s name, the investigator’s name, and a narrative with a summary of significant findings, protocol deviations, deficiencies, and the actions taken or planned. This ensures that issues are identified, tracked, and resolved, and that data integrity and subject safety are maintained.

Including only a list of subjects enrolled provides insufficient information about conduct, compliance, and corrective actions. Budget details are not appropriate content for a monitoring report, and sponsor’s competitor data is irrelevant and inappropriate.