Protocol Deviations in Clinical Trials Explained in Brief Protocol deviations occur when trial activities depart from the study protocol. Missed visits, eligibility errors, and incorrect procedures are possible examples. Investigators document deviations and assess their potential impact. Important deviations may require further investigation, reporting, or preventive measures. Not every deviation requires a formal corrective and preventive action (CAPA) process. Clinical trials are carefully planned, but the people and circumstances involved aren’t always predictable. A participant might miss an appointment, a laboratory assessment could happen later than scheduled, or a research team might discover that a procedure wasn’t completed as required… READ MORE »
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