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Introductory ICH GCP Course to Submit International Clinical Trials

This course was previously called “Light ICH-GCP training – Submission”. Learn about basic Good Clinical Practice principles and get a thorough introduction to the submission of international clinical trials in ICH regions 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
  • Roles in clinical research
  • Abbreviations and terminology
  • Review procedures ethics committee and the competent authority
  • IEC submission requirements, timelines, and decisions
  • Composition of a standard research dossier
  • Terms and obligations after approval

 

DESCRIPTION

The Introductory ICH GCP course is the ideal introduction to Good Clinical Practice (GCP) and the submission of clinical research files. It gives you the tools you need to compose the standard research file, how to submit the files to the ethical review committee, and any conditions and obligations you are facing after approval.

This course is specifically tailored to the requirements for clinical trials in ICH regions and helps anyone involved in the submission phase of international clinical trials. It is an ideal introductory course for sponsor and CRO staff, clinical trial assistants, and research coordinators.

  • 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 Submission 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, including the Declaration of Helsinki, and ICH GCP E6 Addendum R2. 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 ICH 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: Introduction

You’ll learn the following in this module:

  • Introduction to medical research
  • Types of clinical research (interventional, therapeutic, multi/single center)
  • History of legislation and regulations clinical research (Code of Nuremberg, Declaration of Helsinki)
  • The principles of ICH GCP, including the E6 R2 Addendum
  • Implementation in laws of Europe, Japan, USA, and other ICH regions.
  • The roles in clinical research (sponsor, review board, the competent authority, monitor, auditor, investigator, research professional)
  • Additional requirements for clinical trials of a medicinal product
  • Phases of a clinical trial of a medicinal product
  • Abbreviations and terminology in medical scientific research

Module: Submission

You’ll learn the following in this module:

  • Composition of standard research file
  • Composition and procedure reviewing committee
  • Review by an ethics committee
  • Review by the competent authority
  • Review deadlines and changes
  • Review process and approval
  • Terms and obligations after approval

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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 ICH GCP Course to Submit International Clinical Trials

  1. matyas@igina.net –

    I was able to work at my own pace and finish my course sooner than expected.

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