ISO 14155 2020 New Responsibilities of Sponsor/CRO

$99.00

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.

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

Course Breakdown

Section Time
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

Exam and Certifications

  • Final Test – ISO 14155 2020 New Responsibilities of Sponsor/CRO
  • Certification

Description

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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