This online training will provide you with an overview of definitions, requirements and procedures related to safety management in clinical research.
Topics:
- Legal and regulatory framework of safety reporting
- Assessment of adverse events
- Documentation and reporting of adverse events
- Safety and protective measures
- Annual Safety Reports
Different types of studies defined by the Human Research Act (HRA) are covered in two different courses:
Course 1: Safety Management in Clinical Research
- Clinical trials with medicinal products
- Other clinical trials
- Human research projects
Course 2: Safety Management in Clinical Research
- Clinical trials with medical devices
This course has been updated according to the new regulations on clinical trials with medical devices, which came into force on 26 May 2021.
You will find more information about the MDR revision here.