Expert ICH GCP Course for Sites in International Clinical Trials

This online course is based on the investigator’s responsibilities as documented in chapter 4 of ICH GCP E6(R2). Learn everything you need to know to master the investigator responsibilities of ICH GCP for international clinical trials via this highly interactive, self-paced, and certified GCP e-learning course, aimed at site staff. Includes 6 interactive modules and a test of 25 questions.

€ 99.00

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LEARNING OBJECTIVES

You’ll specifically learn about:

  • the principles and background of ICH-GCP
  • Declaration of Helsinki
  • the relationship the site has with the principles and the intentions of GCP
  • the activities leading to the decision to participate in the trial
  • the ethical and scientific quality standards that lead to protection of the trial subjects and reliable trial results
  • submission of the research proposals to ethical review committees
  • the site’s preparations for the trial
  • the conduct of the trial
  • roles and responsibilities during the conduct of the trial
  • the site’s role during the trial including informed consent, safety reporting, IP Management, and quality controls
  • the requirements for closing the trial and archiving

DESCRIPTION

The online course to ICH GCP for Sites is designed for clinical research professionals who lead and conduct international clinical trials in sites in ICH regions and need to be aware of the site’s responsibilities as laid down in Chapter 4 of the Good Clinical Practice guideline applicable to clinical research with human subjects. This training is applicable for (principal) investigators, research nurses, and research coordinators, and all other site staff. It allows you to conduct clinical research in compliance with GCP and is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the GCP 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 6 online training modules in a logical order: from the design to the close-out of a clinical trial. It represents a total workload of 4 hours. The modules are divided into chapters of 10 to 20 minutes and consist of the guidelines which apply to international clinical trials, including the Declaration of Helsinki, and ICH-GCP (R2). It is concluded with a 25-question test, to confirm your knowledge. After you have completed all components of the ICH-GCP e-learning course, you will receive a GCP Certificate. This course complements the Expert ICH-GCP for Sponsors which fulfills requirements for the mutual recognition of GCP training. All training courses include one year of 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 about the following:

  • The Purpose of GCP
  • Responsibilities & Qualifications
  • Documenting Clinical Trials

Module: Trial Set-Up

You’ll learn about the following:

  • Site and Investigator Selection
  • Agreements

Module: Submission

You’ll learn about the following:

  • Submitting for Ethical Review
  • Continued Review

Module: Submission

You’ll learn about the following:

  • Clinical Trial Review
  • Continued Review

Module: Trial Preparation

You’ll learn about the following:

  • The Trial Team
  • The Investigational Product
  • Quality Management

Module: Start & Conduct

You’ll learn about the following:

  • Protocol Compliance
  • Informed Consent
  • Special Consent
  • Investigational Product
  • Subject Safety, Definitions & Reporting
  • Trial Documentation
  • Quality Control & Assurance

Module: Close-Out & Archiving

The knowledge test includes:

  • Trial & Site Close-out
  • Archiving

Module: Knowledge Test

The knowledge test includes:

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

Related products

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.

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