A Quality Management Plan (QMP) is a formal document describing how quality will be built into a clinical trial through planned controls, oversight, and monitoring activities.
QMPs often outline critical-to-quality factors, risk assessments, monitoring approaches, data integrity safeguards, vendor oversight, and escalation pathways. They help sponsors and trial teams align on what will be measured, how issues will be detected, and how corrective actions will be managed. A well-defined QMP supports consistent implementation across sites and vendors, reducing variability that can weaken results. QMP documentation provides clear evidence of proactive quality planning during audits and inspections.