This two-day course will train you in the basic yet crucial areas within clinical monitoring. All typical tasks of a Clinical Research Associate (CRA) will become clear to you, from selecting the investigators to study site close-out, with detailed focus on the “monitoring practice”.
Focussing on the different phases of the life cycle of a clinical trial, this introductory two-day course is specifically designed for professionals who have between zero to twelve months’ experience.
It is, however, mandatory to have previously attended a training on “Good Clinical Practice (GCP)”, as the aim of this course is to enable you as a CRA to implement the GCP requirements into your daily monitoring tasks. Therefore, in order to achieve best outcome for this course you should be GCP trained. In case you are not GCP trained already you could attend our ICH-Good Clinical Practice Training or alternatively any other accredited GCP course before you begin this course.
Course time9h00 - 17h00
Who should attend
No previous knowledge of clinical research is required. A must for all inexperienced CRAs, experienced Clinical Trial Assistants or Clinical Trial Coordinators. This course will also be beneficial to people working in related areas such as clinical data processing, (bio-) statistics, regulatory affairs, etc.
- Introduction to clinical research
- Overview of the applicable legislation
- The life cycle of a clinical trial
- Monitoring activities at different stages
- Trial documents and trial management in practice: study subject recruitment & management, source data verification, investigational product management, safety reporting, clinical data monitoring and quality assurance
- Identification of the right investigator
- Pre-study organization - SDV (source data verification) and monitoring – Database lock - Study closure
- Learn the basics and different phases of clinical research
- Grasp understanding of overall legislative requirements
- Be familiar with expected job tasks of a CRA from the start to the end of a clinical trial
- Comprehend trial documentation
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) (8)
- Study and Site Management (2)
- Data Management and Informatics (4)
- Leadership and Professionalism (0)
- 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