Risk Based Monitoring is a hot topic nowadays. It must be implemented in your organisation, but you do not know how to do it and where to start? 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 as recommended by ICH-GCP E6 (R2). 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 be discussed as well.
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.
- 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 Operation Managers Data managers and Clinical Project Managers who want to get hands-on training with real-live cases ready to be implemented.
- Prior experience in and/or knowledge of ICH-GCP and Clinical Research is required (at least 2 years in the field)
- Rationale for Risk Based Monitoring
- Risk Based Monitoring Methodology
- Risks Identification
- Critical data and Risk indicators analysis
- The Risk Plan
- Monitoring execution within Risk Based Monitoring
- Risk Based Monitoring roles and responsibilities
- Risk Based Monitoring implementation
Study cases and testimony from pharmaceutical industry
- A seasoned Risk Based Monitoring expert from pharma industry will present how this new monitoring approach has been implemented in his organization.
- Live demo of a Risk Based Monitoring enabling tool
- Identify assess and response to risks associated with clinical projects
- Learn how to identify critical data
- Evaluate the risk indicator and set thresholds
- Identify the different actions needed linked to risk identification
- Learn how to implement this new concept within your organisation
- Learn about technologies available to enable RBM
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (6)
- Study and Site Management (3)
- Data Management and Informatics (6)
- 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