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.
What's included?
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition
Course schedule
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:
eLearning: 4 hours
One Day face-to-face training: 09h00-17h00
Webinars with eLearning:
eLearning: 6 hours
Webinars: 2 sessions of 3 hours
23 March 2022
25 March 2022
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.
Programme highlight
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
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
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.
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
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.
Susanne Lifka
Morphosys
01/11/2017
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.
Axelle Vankemmel
AdHoc
01/02/2019
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.
Simone Bucerius
FGK
01/05/2019
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.
Gemma Bruno
Ime Fraunhofer
10/02/2020
Intensive course taught by an experienced trainer that allowed enough time for workshop and interactive oriented practice sessions. It was a structured learning experience for me, with the opportunity to have a good exchange with peers.
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Michelle Kelly
RCSI
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.
Susanne Lifka
Morphosys
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.
Axelle Vankemmel
AdHoc
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.
Simone Bucerius
FGK
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.
Gemma Bruno
Ime Fraunhofer