A Standard Operating Procedure (SOP) is a controlled document that defines how specific tasks must be performed to ensure consistent, compliant execution.
SOPs cover core trial activities such as informed consent, safety reporting, investigational product handling, deviations, monitoring, and document control. Regulators expect SOPs to be current, approved, and actively implemented through training and compliance monitoring. SOP adherence reduces variability across sites and teams, lowering the risk of recurring quality issues. Strong SOP systems are foundational to an effective Quality Management System and inspection readiness.