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
- Course Type: Video Lecture
- Language: English
- Level: Intermediate
- Session: year 2020
- Time: 1 - 3 Hours
|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
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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