(1 customer review)

Expert Online GCP Course for Clinical Trials in Europe

This course was previously called “Blended EU-GCP training”. In this mix of self-paced e-learning and live online training, you will learn everything you need to know to master ICH-GCP and EU laws applicable to European clinical trials. Includes 7 interactive e-learning modules and 3 live online training sessions of 3 hours. For individual registrations.

 175.00

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LEARNING OBJECTIVES

  • Principles of ICH GCP and the ICH GCP Addendum R2
  • EU Directives 2001 & 2005
  • Declaration of Helsinki
  • Privacy laws EU (GDPR)
  • Roles and responsibilities in clinical research
  • Abbreviations and terminology
  • Development of trial protocol
  • Selection of site and research staff
  • Setting up quality assurance: monitoring plan, auditing, DSMB, SOPs
  • Agreements
  • Review procedures
  • Terms and conditions
  • Recruitment of subjects and requirements for research with vulnerable subjects
  • Safety, including reporting of SUSARs
  • Documentation
  • Quality Management
  • Completion and archiving of clinical trials

 

DESCRIPTION

The expert course to GCP in Europe is the self-paced online training solution for researchers, pharma professionals, and research staff who conduct clinical trials in Europe, and need to be aware of the Good Clinical Practice guidelines and EU laws applicable to clinical research with human subjects. It is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the regulatory framework to practice and gives you the tools to directly implement the knowledge in your daily practice.

  • Transcelerate acknowledged GCP certificate
  • Efficient and interactive learning
  • Easy accessible via smartphone, tablet, or desktop
  • Self-paced and modular

The course consists of 7 online training modules in a logical order: from the design to close-out of a clinical trial. It represents a total workload of 6 hours. The modules are divided into chapters of 10 minutes and consist of the guidelines which apply to international clinical trials, including the Declaration of Helsinki, ICH GCP E6 Addendum R2, EU Directives 2001, and 2005 and the EU Privacy law.

After you have completed all components of the GCP e-learning course, for clinical trials in Europe you will receive a GCP Certificate, recognized by Transcelerate.

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: Design
Module 3: Preparation
Module 4: Submission
Module 5: Start
Module 6: Conduct
Module 7: Archive (Close-out)

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 Expert Online GCP Course for Clinical Trials in Europe

  1. Published

    The GCP course was excellent! I appreciate the online, self-paced learning.

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