Do you want to refresh and improve your CRA skills? Do you need some inspiration to boost your clinical trial monitoring techniques and approach? This blended learning course provides, the experienced monitors, with the knowledge and skills to deal with the more complex clinical trials and site management issues. The face to face training, supported by eLearning, gets the best outcome and you can learn at your own pace.
Through an interactive approach, in this blended learning course, you receive a concise update of the current European clinical trial legislation and you will learn more about clinical trials in developing countries. The critical milestones of clinical trials, contingency plans, dealing with non-compliances, risk-based monitoring, your relationship with the investigator and coaching junior CRAs are the main topics.
The face-to-face session will implement the eLearning materials in practice: how to upgrade monitoring methods and skills, how to select the right investigators, how to boost recruitment of clinical trial subjects, how to detect and correct informed consent issues, how to solve site management matters and how to deal with non-compliance. You gain insights in developing monitoring plans, tracking tools, accurate monitoring visit reporting and corrective and preventive actions. You will be dealing with cases from real situations in the workshops.
Lively discussion and action planning session with all participants are main in the classroom part as real-life cases are analysed and actions will be discussed. Here you will benefit not only from the trainers 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. After attending the classroom part, you will be able to test your comprehension with a final overall grading assessment.
All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeClassrooms: 09h00 - 17h00 / eLearning: Course Credits: 6 hours
Who should attend
Clinical Research Associates (CRAs) with min 2 years of experience, who want to boost their CRA skills and to set new objectives in their career and/or experienced people working in clinical data processing, biostatistics, regulatory affairs, etc.
If you have a particular interest in clinical trials with medical devices, you may prefer to attend our “Running Medical Devices Trials” course.
- Importance of international research – the role of the ICH process,
- Update on overview of the current European legislative requirements, including guidance on substantial trial modifications,
- Questions and Answers on a monitoring plan
- Selection of the right investigator,
- The informed consent: verification of the process,
- Improving recruitment of study subjects and tips for site staff to enhance subject retention,
- Upgrading monitoring tasks: prioritizing monitoring activities, accurate monitoring reporting, efficient tracking, dealing with non-compliances,
- Coaching junior CRAs.
- Be up-to-date on current European legislative rules,
- Manage investigational sites better from screening to database lock,
- Take the right actions to resolve site issues, ascertain appropriate corrective and preventive actions,
- Expand your knowledge and improve your monitoring skills
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (5)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (5)
- Data Management and Informatics (5)
- Leadership and Professionalism (3)
- Communication (3)
- 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