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.

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

Course Breakdown

Section Time
Introduction 00:00:30
Responsibilities of Principal Investigator 00:02:31
Qualification of the Principal Investigator and Site 00:01:21
Communication 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

Exam and Certifications

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

Description

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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