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ISO 14155 2020 Responsibilities of Principal Investigator

$99.00

This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities.

Description

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.

 

TOPICS

  • Introduction (00:00:30)
  • Responsibilities of Principal Investigator (00:02:31)
  • Qualification of the Principal Investigator and Site (00:01:21)
  • Comunication 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)

  • Final Test – ISO 14155 2020 Responsibilities of Principal Investigator
  • Certification

Additional information

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