Clinical Trial Monitoring, Safety Reporting & Quality Assurance

Learn how monitoring strategies protect data quality and participant safety. This course introduces risk‑based and centralized monitoring models, medical monitoring basics, SAE/ADR classification and reporting, protocol deviation handling, and quality management systems (QMS) for continuous improvement.

Course Benefits & Career Prospects

• Compare risk‑based, centralized, and traditional monitoring approaches.
• Identify, classify, and escalate safety events (SAEs/ADRs) appropriately.
• Document and manage protocol deviations/non‑compliance.
• Contribute to quality oversight through QMS concepts in clinical research.
• Job placement assistance: monitoring support, safety coordinator, QA assistant roles.

Modules

• Risk‑Based Monitoring (RBM)
• Centralized Monitoring
• Medical Monitoring, SAE/ADR Classification & Causality Assessment
• Safety Reporting in Clinical Trials
• Protocol Compliance & Deviation Handling
• Quality Management System (QMS) in Clinical Research