(1 customer review)

Expert Blended 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.

 425.00

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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
  • Regular study completion and early termination
  • Completion and archiving of clinical trials

 

DESCRIPTION

The expert blended GCP course for clinical research in Europe is the optimal mix: learn about GCP guidelines and European legislation online, at your own pace, and apply the GCP rules to practical situations in an instructor-led (virtual) classroom session at our training facility in Amsterdam.

The self-paced online course gives you a practical understanding of the ICH GCP guidelines and European legislation in a logical order: from design to the closeout of clinical trials. After completion of the 7 modules of the online course, you have the knowledge to have in-depth discussions at the (virtual) classroom session.

The program of the classroom session is tailored to the needs of the attendees and allows maximum interaction. You are challenged to apply your GCP knowledge to solve practical case studies. You will exchange knowledge and experiences with peers and have in-depth discussions with the trainer to maximize your learning experience.

This course is ideal for starters in the clinical research industry in Europe or experienced staff looking for an extensive update on ICH GCP and European legislation.

The completion of the training takes 15 hours, including 6 hours of online learning and 3 virtual* classroom session of 3 hours. (*We provide virtual classroom training due to corona restrictions)

After you have completed all components of the blended GCP course for Clinical Trials in Europe, you will receive a GCP Certificate, recognized by Transcelerate.

All training courses include one-year access to your 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)
Module 8: (Virtual) classroom session

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 Blended GCP Course for Clinical Trials in Europe

  1. Published

    Very great learning system and very complicate questions which help me to read and know more.
    Not only to keep updated in License or my profile but also helps me to increase my research knowledge in my carrier.
    I really appreciated
    Thank you so much

    Dr Tadesse Teame
    Phd Researcher Molecular Scientist
    Hager Biomedical Center

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