Description
This training is essential for clinical research staff, as it provides a comprehensive foundation in quality management principles that are crucial for ensuring compliance, safeguarding data integrity, and supporting patient safety. The modules cover key areas such as risk management, issue resolution, root cause analysis, and the development of corrective and preventive actions. By equipping participants with practical skills in audit preparation, hosting, and closure, the programme helps staff maintain regulatory standards and fosters a culture of continuous improvement. Ultimately, this training empowers clinical research teams to deliver robust, high-quality studies that meet global expectations and withstand regulatory scrutiny
Course Duration
Approximately 4 hours of structured training, delivered through six focused modules designed to provide practical knowledge on quality management, risk management, and audit readiness in clinical trials.
The course can be completed at your own pace, allowing learners to revisit modules as needed.
Course Structure
The course is divided into six practical modules covering key aspects of quality management in clinical trials:
Module 1: Introduction to Quality Management Systems (QMS)
Understand the role of quality systems in clinical trials, including how QMS supports compliance with ICH-GCP, regulatory requirements, and data integrity.
Module 2: Basics of Quality Risk Management
Learn how to identify, assess, and mitigate risks in clinical trial processes to ensure participant safety and reliable study outcomes.
Module 3: Quality Issue Management
Understand how to identify, document, and investigate quality issues, deviations, and compliance gaps during a clinical trial.
Module 4: Root Cause Analysis (RCA) & Impact Analysis
Learn practical methods such as the 5 Whys and Fishbone Analysis to determine the root causes of trial issues and assess their impact.
Module 5: Corrective and Preventive Action Plans (CAPA)
Develop effective CAPAs to resolve issues and prevent recurrence, while ensuring continuous improvement in clinical trial quality systems.
Module 6: Audit Preparation, Hosting & Closure
Gain practical guidance on preparing for audits, interacting with auditors, and managing audit findings and CAPA closure.
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