Risk Management in Clinical Research and Trials Training Course

Course overview

Effective risk management is now at the heart of running high‑quality, compliant clinical trials. With the shift toward proportionate, risk‑based approaches in ICH E6 (R3), E6 (R2), and ICH E8(R1), teams are expected not only to identify and evaluate risks early, but also to monitor and respond to them in a structured, transparent way throughout the trial lifecycle.

This interactive one‑day course gives you the confidence and skills to apply modern risk management principles in real studies. Through clear explanations, real‑world examples, and interactive discussions, we explore what regulators expect, how risk‑based quality management works in practice, and how to build a process that supports both participant safety and high‑quality data.

The course also introduces the growing role of AI in clinical trial risk management. You’ll learn how emerging tools can support early risk detection, help identify unusual data patterns, and strengthen centralised monitoring - while also understanding their limitations and the importance of maintaining strong documentation, oversight, and human judgement.

By the end of the day, you will be equipped to design, implement, and document a practical, proportionate risk management approach that aligns with the latest global expectations and supports successful clinical trial delivery.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

• Understand key risk management tools and when to apply them in pharma, biopharma, projects
• Learn how to plan, document, and focus risk-based approaches to meet ICH GCP E6 (R2), E6 (R3), and related regulatory expectations
• Identify and share best practices for implementing risk-based tools and approaches in clinical trials including AI
• Gain a clear understanding of the risk management objectives outlined in ICH E6 (R3) and ICH E8(R1)

Who should attend

This course is designed for professionals in the pharmaceutical, biotechnology industry who need to understand and apply risk management in clinical research, including:

• Clinical Research Associates (CRAs)
• Clinical Trial Managers (CTMs)
• Quality Assurance professionals
• Regulatory Affairs specialists
• Project Managers
• Data Managers
• Anyone needing to meet regulatory expectations and apply risk-based tools and techniques effectively in their role

Enrol/reserve