Which scenario best constitutes noncompliance?

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Noncompliance occurs when someone fails to follow the rules that govern a clinical study—the regulatory requirements or the study protocol. This is more serious than a simple deviation because it directly jeopardizes participant rights, safety, or the integrity of the data. The other scenarios describe deviations that are either minor and promptly corrected, or deviations that are approved and documented as part of normal study management; these are monitored and controlled rather than classified as noncompliance. Therefore, the statement about not adhering to regulatory requirements or the study protocol best represents noncompliance.