- Introduction (00:01:25)
- Ethical Considerations (00:02:26)
- Responsibilities (00:04:03)
- Vulnerable Subjects (00:00:49)
- Informed Consent (00:08:35)
ISO 14155 2020 Ethical Considerations
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for Ethics and the informed consent process.
Why take this course
A thorough understanding of the ethical changes from ISO 1455:2011 will aid in designing clinical trials that meet regulatory standards.
What I will learn
This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2011 on:
- Ethical considerations: relevant ISO 14155 2020 sections
- Improper influence or inducement
- Compensation and additional health care
- Registration in publicly accessible database
- Communication with EC
- Vulnerable subjects
- Informed Consent
Skills I will gain
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 standard.
MEET THE MEDITRIAL EXPERTS
- Final Test – ISO 14155 2020 Ethical Considerations
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