Risk Based Monitoring is a hot topic nowadays. Do you have the feeling that many people talk about it, but that these conversations stay vague or abstract? Our blended learning programme for implementing Risk Based Monitoring is the ideal solution for you then. The combination of eLearning and classroom training allows you to assimilate the theoretical concepts at your own pace, whilst you have the opportunity for interacting with our experts and sharing experiences during the interactive classroom part.
This blended course introduces the ins and outs of risk based monitoring in clinical trials. It will give you the rationale for implementing this new approach and how to set it up within your organisation. Through an interactive approach, it will provide you with the basics for risk based monitoring processes applied to clinical trials. You will learn how to define, evaluate and respond to risks and also how to define the critical data, the risk indicators and the thresholds linked to it. Additionally, you will go through the different steps to be taken for implementing this new monitoring methodology. The roles and responsibilities of each stakeholder will also be discussed.
The classroom session will provide cases and workshops on the eLearning content, allowing you to implement it in your daily practice. Lively discussions and action planning sessions with all participants are the main component of the classroom part. Here you will benefit not only from the trainer’s but also learn from each other’s experiences. Seasoned industry experts contribute to this programme providing their real life experience, including a live demonstration of a Risk Based Monitoring enabling technology.
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 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.
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 credits : 6 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 time09:00 - 17:00
Who should attend
Clinical Research and Project Managers, Senior Clinical Research Associates (CRAs) who want to get hands on training with real-live cases ready to be implemented. Investigational site staff confronted with the RBM approach.
- Rationale for Risk Based Monitoring
- Risk Based Monitoring
- Risks Identification
- Critical data and Risk
- The Risk Plan
- Monitoring execution within Risk
- Risk Based Monitoring roles and
- Risk Based Monitoring implementation
- Identify assess and response to
risks associated with clinical projects
- Learn how to identify critical data
- Learn about technologies available to enable RBM
- Evaluate the risk indicator and set thresholds
- Identify the different actions needed linked to risk
- Learn how to implement this new concept within your