This online training provides you with an overview of definitions, requirements and procedures related to safety management in clinical research. The course content focusses on the specific requirements in Switzerland.
Topics:
- Legal and regulatory framework of safety reporting
- Assessment of adverse events
- Documentation and reporting of adverse events
- Safety and protective measures
- Annual Safety and Progress 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 I
- Clinical trials with medicinal products
- Other clinical trials
- Human research projects
Course 2: Safety Management in Clinical Research II
- Clinical trials with medical devices
Further information: