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ISO 14155 2020 Clinical Trial From Start To Finish

$99.00

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout.

Description

Why take this course

To ensure and keep up-to-date on regulatory standards for clinical trials; To effectively apply investigation requirements for medical devices, and to better align clinical research procedures with those of the Good Clinical Practice (GCP) guidelines.

What I will learn

This tutorial provides an overview of the main changes introduced by ISO 14155: 2020 on different steps of the clinical investigation:

  • Planning
  • Conduct
  • Suspension, termination and close-out

 

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 (00:01:09)
  • Clinical Investigation Planning (00:08:07)
  • Monitoring Plan (00:05:29)
  • Clinical Investigation Conduct (00:06:57)
  • Document and Data Control (00:06:08)
  • Suspension, termination and close (00:08:12)

  • Final Test – ISO 14155 2020 Clinical Trials from Start to Finish
  • Certification

Additional information

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