What is the purpose of monitoring visits and source data verification in trials?

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Monitoring visits and source data verification are about safeguarding participants and ensuring the trial runs as planned. They provide a check on protocol adherence, making sure procedures are followed correctly and eligibility criteria are applied consistently. Source data verification involves comparing information in the case report forms with the original source documents (like medical records, lab results, and consent forms) to confirm that data are accurate, complete, and consistent. This also includes confirming that informed consent was obtained appropriately before procedures and that adverse events and other key data are properly documented. Together, these activities help ensure data integrity, participant safety, and regulatory compliance, rather than speeding recruitment, publishing results faster, or replacing data management.