- 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)
ISO 14155 2020 New Responsibilities of Sponsor/CRO
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.
Why take this course
To gain knowledge of and adhere to new regulatory standards set forth in the conformity assessment of medical devices.
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
- Final Test – ISO 14155 2020 New Responsibilities of Sponsor/CRO
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