- Introduction (00:00:30)
- Responsibilities of Principal Investigator (00:02:31)
- Qualification of the Principal Investigator and Site (00:01:21)
- Comunication with the EC (00:01:36)
- Informed Consent Process (00:01:26)
- Compliance with the CIP (00:02:48)
- Medical Care of Subjects (00:01:46)
- Safety Reporting (00:01:21)
ISO 14155 2020 Responsibilities of Principal Investigator
This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities.
Why take this course
To adhere to the newly revised standard of ethical and scientific conduct for Principal Investigators; to maintain credibility of clinical trial management.
What I will learn
This tutorial provides an overview of the main changes introduced by ISO 14155:2020 on:
- Qualification of the PI and investigation sites
- Communication with the EC
- Informed consent process
- Compliance with the CIP
- Medical care of subjects
- Safety reporting
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.
- Final Test – ISO 14155 2020 Responsibilities of Principal Investigator
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