You want to know the ins and outs of risk management in clinical research? You want to be prepared and try to avoid being a fireman in your trials? Follow this blended learning course with a focus on risk analysis and risk management techniques in clinical projects. It will show you how risk management can improve the quality of your project. The face to face training, supported by eLearning, gets the best outcome and you can learn at your own pace.
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.
This course is a blended learning course, which means it is broken into two parts.
The eLearning session must be attended before the face to face training as its content fits to the practical approach during face-to-face training.
- eLearning : At your own pace; the course will be available as soon as the face-to-face session is confirmed (3 weeks prior to the face to face session date as a minimum). Course credit : 4 hours
- Face to Face training : One-day face to face training from 09h00 - 17h00
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
Course timeClassroom: 09h00 - 17h00 / eLearning: Course Credits: 4 hours
Who should attend
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.
- 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
- 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
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (1)
- Study and Site Management (1)
- Data Management and Informatics (0)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained