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MDR SUBSTANTIAL STUDY CHANGES, TEMPORARY HALT AND TERMINATION

$179.00

This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination).

Description

Why take this course

This Meditrial Video Course By Monique Latourette is designed to help you discover the provisions and corrective measures regarding the end of the clinical trial and the extraordinary events which could happen during the investigation

What I will learn

This course will highlight the MDR provisions regarding the end of the clinical trial and the extraordinary events which could happen during the investigation

Skills I will gain

  • Understand the substantial modifications to clinical investigations
  • Explore the corrective measures for clinical investigations not compliant with the new Medical Device Regulation
  • Discover when a temporary halt and early termination of a clinical investigation takes place
  • Learn about the end of a clinical Investigation and the clinical investigation report

 

TOPICS

  • Introduction (00:01:55)
  • Modifications and Corrective Measures (00:04:30)
  • Sponsor Obligations (00:01:42)
  • Report and Related Summary (00:01:42)
  • MDD vs MDR (00:03:32)
  • Conclusion (00:00:44)

  • Final Test – MDR Substantial Study Change, Temporary Halt and Termination
  • Certification

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