This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities.
ISO 14155 2020 Responsibilities of Principal Investigator
- Course Type: Video Lecture
- Language: English
- Level: Intermediate
- Session: year 2020
- Time: 1 - 3 Hours
|Responsibilities of Principal Investigator||00:02:31|
|Qualification of the Principal Investigator and Site||00:01:21|
|Communication 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|
Exam and Certifications
- Final Test – ISO 14155 2020 Responsibilities of Principal Investigator
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.
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