Quality Assurance, Monitoring and Safety

Quality is a system, not a hope. This level separates quality assurance from quality control, gives you the everyday QC and monitoring activities that catch errors, and shows how to handle deviations, safety events and root-cause fixes so your data and your participants are protected.

Who this level is for

PIs, coordinators, data managers and quality or monitoring staff. Recommended after Levels 1-4.

What you'll learn

• The clear difference between quality assurance (system-level: audits, process and SOP reviews) and quality control (routine checks during data collection)
• Practical QC activities: source-data verification spot checks, range and logic checks, and query management as a process
• What monitoring visits and internal audits look like, and how they differ from supervision
• How to identify, assess and log protocol deviations and violations
• Safety reporting basics: AE, SAE and SUSAR, the reporting pathways, and a proportionate approach for minimal-risk studies
• CAPA: root-cause analysis and designing corrective and preventive actions that you verify actually worked

You finish with: A QA/QC plan with a worked deviation example and a CAPA.