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
$99.00
- Course Type: Video Lecture
- Language: English
- Level: Intermediate
- Session: year 2020
- Time: 1 - 3 Hours
Original price was: $495.00.$470.25Current price is: $470.25.
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:00:30 |
| 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 |
| Safety Reporting | 00:01:21 |
Exam and Certifications
- Final Test – ISO 14155 2020 Responsibilities of Principal Investigator
- Certification
Description
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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