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GDPR & Clinical Trials

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This Meditrial Video Course explains the fundamental concepts of GDPR and clarifies the impact of this regulation on the conduct of clinical trials.

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Description

Why take this course

The European general data protection regulation, GDPR (Regulation (EU) 2016/679) is applied in Europe as of May 25th, 2018. It has replaced the EU Data Protection Directive.

This Meditrial Video Course explains the fundamental concepts of GDPR and clarifies the impact of this regulation on the conduct of clinical trials.

What I will learn

  • Data protection requirements and obligations as per the GDPR (Regulation (EU)2016/679)
  • Responsibilities and obligations of healthcare professionals, clinical researchers and companies
  • How to make an action plan for your organization to ensure timely compliance

Skills I will gain

  • Understand the basic principles, framework and process described in the general data protection regulation, GDPR (Regulation (EU) 2016/679)
  • Assist your organization in setting strategy and achieving compliance for personal data and clinical trials
  • Extend your learning on this subject with additional related courses to create value in your organization
  • On completion, you’ll earn a certificate by Meditrial, an internationally recognized ISO 9001 certified provider of medical and regulatory education

 

TOPICS

  • Introduction (00:01:12)
  • What is the GDPR? (00:05:06)
  • GDPR & Good Clinical Trials (00:01:19)
  • Study Sponsor & GDPR (00:00:53)
  • How to comply with GDPR (00:00:49)

  • Final Test – GDPR & Clinical Trials
  • Certification

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