Risk Management in Clinical Research – Blended
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|08/11/2023||Risk Management in Clinical Research||Brussels||EUR 950.00||Book|
|If you would like to have this course as an in-house session click here|
About this course
Reasons to attend
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.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
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.
Classroom with eLearning:
Webinars with eLearning:
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.
This was an excellent course. The quality of the presentations was very high and the trainers were competent, helpful and professional. Questions and interaction were encouraged and this generated useful and informative discussions and made the training interactive and enjoyable as well as informative.
I enjoyed the discussions. I learned a lot from the trainer but also from the experiences of other participants.
It gives an idea why and how risk management is necessary not only in theory but with realistic examples/ discussions. I realised that we do it already, but not naming it risk management. Now we need to start doing it on paper for documentation purposes, within the whole CTT and on a whole clinical trial level. Not only on small projects within a clinical trial.
I learned that we should pay more attention to the risks that the study may have, to identify those risks, to determine the risk and decide what action must be taken, to focus on critical processes and data and that it is better to have a risk-based monitoring then 100% SDV to increase data quality. For me it was very good to have exercises and to discuss with other attendees. In this way, you learn how to use risk-based monitoring in practice.
The course offers a very good introduction to Risk Management in clinical trials. It is a great advantage that all participants are at the same level of knowledge at the beginning of the face-to-face-training due to the eLearning session that has to be completed in advance. I liked the combination of theory and workshops, which resulted in fruitful discussions. Our trainer was very responsive to our in-house procedures. That helped us to improve our approach.