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Introductory ECTR Course for Clinical Drug Trials in the Netherlands

This course was previously called “ECTR Foundation – NL”. Our Introductory ECTR e-learning course teaches you the essentials of the upcoming European Clinical Trial Regulation and the impact on Clinical Drug trials in the Netherlands. Includes 1 interactive module, 1 test, and takes 1.5 hours to complete.

€ 50.00

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LEARNING OBJECTIVES

  • Principles of ECTR (EU Clinical Trial Regulation)
  • Critical timelines for submission and review of a dossier
  • Transition period and expected implementation
  • Impact on the conduct of a clinical drug trial in Europe
  • Understand the changes and be prepared for its implementation in 2021

 

DESCRIPTION

ECTR stands for European Clinical Trial Regulation. This is the new EU regulation on clinical trials of medicinal products for human use which replaces the existing Directive 2001/20/EC. The ECTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved.

The Introductory ECTR course for clinical trials in Europe explains the principles of the new regulation, clarifies the critical timelines, helps you understand the changes, and be prepared for its implementation in 2021. Be ECTR ready.

  • 1.5 hours
  • 1 Learning Module
  • Online ECTR certificate
  • Knowledge Test
  • Available on desktop, smartphone or tablet
  • Accreditated by several quality registers

It is an ideal introductory course suitable for anyone (clinical and non-clinical) involved or interested in medical science and drug research. The course enables you to get a good overview of the new regulations and the consequences of the implementation of clinical drug research. It is perfect for: doctors, research nurses, patients, students (medicine or biology), clinical trial assistants, employees of CROs, employees of (hospital) pharmacies.

The online course takes 1.5 hours and consists of the basic ECTR module and a knowledge test. After completion, you will receive an online ECTR certificate.

 

COURSE CONTENTS

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You’ll learn the following in this module:

  • Goal ECTR and difference between a Directive and Regulation
  • Scope of ECTR: to which type of research is the ECTR applicable?
  • Dutch ambition regarding the introduction of the ECTR
  • High-level contents of the ECTR
  • Opportunities, benefits, and challenges of the ECTR and submissions via the CTIS portal
  • When will the ECTR be implemented and what does the transition period look like?
  • Timelines of the submission- and review process according to the ECTR regulation
  • Differences in the submission of a national trial and an international trial
  • Results of the validation phase, Assessment part I and assessment part II
  • Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials

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[toggles title=”Module: Knowledge Test”]
The knowledge test includes:

  • 10 questions
  • Available in English and Dutch
  • Feedback per question (afterwards)
  • 3 attempts
  • Online certificate with a score of 80 or higher

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Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks.  We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

1 review for Introductory ECTR Course for Clinical Drug Trials in the Netherlands

  1. matyas@igina.net –

    A perfect way to learn and understand the complexity of ECTR, but also to receive the knowledge and toolset needed.

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