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.
ISO 14155 2020 Safety and Adverse Events
- Course Type: Video Lecture
- Language: English
- Level: Beginner
- Session: year 2020
- Time: 0 - 1 Hour
|Adverse Events and Device Deficiency||00:02:27|
|Responsibilities of the PI and Sponsor||00:04:52|
|Risks of under-reporting||00:00:33|
Exam and Certifications
- Final Test – ISO 14155 2020 Safety and Adverse Events
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.
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