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).

  • Course Type: Video Lessons
  • Language: English
  • Level: Beginner
  • Session: year 2021
  • Time: 0 - 1 Hour
Add to Wishlist
Add to Wishlist

Course Breakdown

Section Time
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

Exam and Certifications

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

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

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

Title

Go to Top