Clinical operations course
Risk Management in Clinical Research (Blended Learning)
Be prepared and try to avoid being a fireman in your trials.
Dates and booking
Choose your date.
All fees exclude VAT. Booking for several colleagues? Choose the number of participants, or ask about an in-house session.
Who it’s for
Is this course for you?
Clinical Research Managers and Project Managers. Lead Clinical Research Associates (CRAs) who want to set new goals for their career as clinical research project team leaders.
What you’ll learn
About this course.
Course Description
This is a course not to be confused with risk management in pharmacovigilance or Risk Based Monitoring.
It demonstrates the importance of using risk analysis and risk management techniques in Clinical Research Programme Management as recommended by ICH-GCP E6 (R2). It will provide participants with the basics for risk management processes applied to clinical trials.
The face-to-face session will implement the eLearning materials in practice: how to define, evaluate and characterise risks and also how to devise and implement specific techniques and strategies for risk management. Lively discussion and action planning session with all participants are main in the classroom part as interactive workshops are analysed and actions will be discussed. Here you will benefit not only from the trainer’s but also learn from each other’s experiences.
The complementary eLearning course includes interactive quizzes and exercises for self-assessment to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment. Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
Learning objectives
- Identify risks associated with clinical projects
- Learn how to assess risks & avoid risk areas
- Evaluate the risk benefits and prioritize actions
- Reduce impact on other projects and the likelihood of failure
- Develop risk-handling strategies and management plans
- Understand the importance of the risk monitoring and control step in the risk management process
Programme highlights
- Why should risks be managed in Clinical Trials?
- How to identify risks?
- How to analyse risks?
- How to mitigate risks?
- How to monitor and control risks identified?
- How to document the risk management process?
- Risks versus issues and CAPA.
- Difference between Risk Management and Risk Based Management
Your trainer
Your trainer.
Format
How the course runs.
Blended
Classroom: 09h00 - 17h00 /, in Brussels.
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Investigational Product Development and Regulation3
- Scientific Concepts & Research Design1
- Study and Site Management1
- Leadership and Professionalism1
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
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