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Introductory GCP Course to Close Clinical Trials in Europe

This course was previously called “Light EU-GCP training – Close Out”. Learn about basic Good Clinical Practice principles and get a thorough introduction to the close-out of clinical trials in Europe via this highly interactive, self-paced introductory e-learning course. Includes 2 interactive modules.

€ 65.00

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LEARNING OBJECTIVES

  • Principles of ICH GCP and the ICH GCP Addendum R2
  • EU Directives 2001 & 2005
  • Roles in clinical research
  • Abbreviations and terminology
  • Regular study completion and report end of the trial
  • Early termination
  • Requirements for Clinical Study Report
  • Archiving of trial documentation and retention period

 

DESCRIPTION

The Introductory GCP course is the ideal introduction to Good Clinical Practice (GCP) and archiving (closing out) clinical trials in Europe. It gives you the tools you need to deal with the completion of your trial, report the end of your trial, requirements of the final report/ clinical study report, and archiving and retention periods of your research documents.

This course is specifically tailored to the European regulatory framework and helps anyone involved in the archiving (close-out) phase of clinical trials in Europe. It is an ideal introductory course for students, research coordinators, CRAs, and research nurses.

  • Efficient and interactive online learning
  • Easy accessible via smartphone, tablet or desktop
  • Self-paced and modular

The course consists of 2 online training modules: Introduction and Close-out of a clinical trial. It represents a total workload of 2 hours. The modules are divided into chapters of 10 minutes and consist of the guidelines which apply to clinical trials in Europe, including the Declaration of Helsinki, ICH GCP E6 Addendum R2, and the EU Directives. If you require additional knowledge for the execution of other phases of the trial, you can easily add these modules by upgrading to an Expert online GCP training package.

After you have completed all components of the Introductory GCP e-learning course, you will receive a Certificate.

All training courses include one-year access to the online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.

Enroll now to get started with the online learning modules on your smartphone, tablet, or desktop computer.

 

COURSE CONTENTS

Module 1: Introduction
Module 2: Archiving (Close-out)

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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 GCP Course to Close Clinical Trials in Europe

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    The overall training was fruitful for me.

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