ISO 14155 2020 Responsibilities of Principal Investigator

Why take this course

To adhere to the newly revised standard of ethical and scientific conduct for Principal Investigators ; to maintain credibility of clinical trial management. 

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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