This two-day course will train you in the basic yet crucial areas of clinical monitoring.
Focussing on the different phases of the life cycle of a clinical trial, all typical tasks of a Clinical Research Associate (CRA) will become clear to you, from selecting the investigators till study site close-out, with a great focus on the “monitoring practice”.
This course is specifically designed for people who have between zero to twelve months’ experience. It is, however, mandatory to have previoulsy attended a training on "Good Clinical Practice (GCP)", as the aim is to enable you as a CRA to implement the GCP requirements into your daily monitoring tasks. Therefore to get the best outcome for this course you should be GCP trained. In case you are not GCP trained already you could take our ICH-Good Clinical Practice training or alternativity 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
- To understand the basics and phases of clinical research
- To grasp overall legislative requirements
- To be familiar with expected job tasks of a CRA from the start to the end of a clinical trial
- To comprehend trial documentation