Standard of Care (SOC) refers to the accepted medical practice and treatment approach typically used for a given condition in routine care.
In trial design, SOC may serve as the comparator arm, background therapy, or required concomitant treatment to ensure ethical management of participants. SOC definitions affect eligibility criteria, rescue medication rules, and endpoint interpretation because they establish what ìusual careî looks like for the study population. Variability in SOC across regions and sites can introduce operational and scientific complexity in multinational studies. Clear SOC documentation supports consistent execution and improves interpretability of comparative outcomes.