- Introduction (00:02:48)
- Definitions (00:02:30)
- Adverse Events and Device Deficiency (00:02:27)
- Responsibilities of the PI and Spons (00:04:52)
- Risks of under-reporting (00:00:33)
ISO 14155 2020 Safety and Adverse Events
This lecture describes the key changes in the international ISO standard for clinical trials. In this module we will show you the main changes that have occurred compared to the ISO 14155 2011 in the safety and adverse event reporting.
Why take this course
To adhere to the newly revised standard of Adverse Events and Safety Reporting when conducting clinical trials.
What I will learn
Safety and adverse events reporting.
Skills I will gain
This course will help you:
You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the worldwide standard.
- Final Test – ISO 14155 2020 Safety and Adverse Events
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