This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.
ISO 14155 2020 New Responsibilities of Sponsor/CRO
$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 | 00:01:00 |
| Who are sponsor and CRO? | 00:02:52 |
| Documents and materials preparation | 00:01:48 |
| Conduct of Clinical investigation and monitoring | 00:02:20 |
| Safety evaluation and reporting | 00:02:21 |
| Clinical investigation close-out activities | 00:01:00 |
| Responsibilities of the CRO | 00:05:04 |
Exam and Certifications
- Final Test – ISO 14155 2020 New Responsibilities of Sponsor/CRO
- Certification
Description
What I will learn?
This tutorial provides an overview of the main changes introduced by ISO 14155:2020 on:
- Outsourcing of duties and functions
- Clinical Quality Management
- Clinical Investigation Planning and Conduct
- Communication with regulatory authorities
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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