Manual Operation (MOP) refers to trial processes performed by staff without automation, such as paper-based workflows, manual data entry, and human-driven reconciliations.
Manual steps are common during site startup, source documentation, investigational product accountability, and certain safety reporting activities. Because manual workflows increase the risk of transcription errors, delays, and inconsistent execution, they require clear SOPs, role-based training, and quality checks. Documentation standards and contemporaneous recordkeeping are essential to maintain traceability and data integrity. When manual operations are unavoidable, well-designed controls help ensure consistency, auditability, and reliable study oversight.