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 »
In Brief: Security Assurance in Cybersecurity and Testing Security assurance in cybersecurity builds confidence that safeguards work as intended. Control testing uses evidence to evaluate whether security measures are implemented and effective. Assessment results can expose gaps that need remediation before an audit or incident. Reassessment supports ongoing improvement as systems, risks, and controls change. Installing a security control answers one question: Do we have a safeguard? Security assurance asks the harder question: Does it actually work? An organization may require multi-factor authentication, restrict administrator privileges, encrypt sensitive information, or collect security logs. The policy may be documented, and the.. READ MORE »
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