Expert ICH GCP Course for Sponsors in International Clinical Trials

This course is based on the Sponsor responsibilities as documented in Section 5 of ICH GCP E6(R2). Learn everything you need to know to master the Sponsor responsibilities of ICH GCP for International Clinical trials via this highly interactive, self-paced, and certified GCP e-learning course. Includes 6 interactive modules.

 99.00

Additional information

Job Role

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Language

Level

Phase of Study

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Region of Regulation

Regulation

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Expert ICH GCP Course for Sponsors in International Clinical Trials

 99.00

This course is based on the Sponsor responsibilities as documented in Section 5 of ICH GCP E6(R2). Learn everything you need to know to master the Sponsor responsibilities of ICH GCP for International Clinical trials via this highly interactive, self-paced, and certified GCP e-learning course. Includes 6 interactive modules.

Category: Tag:

LEARNING OBJECTIVES

You'll specifically learn about:

  • the principles and background of ICH Good Clinical Practice (GCP)
  • the responsibilities of the Sponsor according to section 5 of ICH GCP in all stages of the trial
  • the ethical and scientific quality standards that lead to reliable trial results
  • quality management, internal quality controls, and quality assurance during the trial set-up
  • the sponsor's involvement in gathering data and preparing documents to submit to the IRB/IEC, the reviewing committee
  • the ethical review that happens prior to the first subject entering a trial
  • the sponsor's role during the trial including monitoring the quality of the conduct of the trial, IP Management, Safety, and quality controls
  • the requirements for closing the trial and archiving

DESCRIPTION

The expert course to ICH GCP for Sponsors is the self-paced online training solution for clinical research professionals who initiate and monitor international clinical trials in ICH regions. It is specifically for those who need to be aware of the sponsor responsibilities as laid down in Chapter 5 of the Good Clinical Practice guidelines applicable to clinical research with human subjects.

This training is applicable for CRA's, research coordinators, sponsor's and initiating investigators. It allows you to initiate clinical research in ICH 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.

• 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 minutes and consist of the guidelines which apply to international clinical trials, including the Declaration of Helsinki, and ICH GCP E6 Addendum R2.

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 Investigators which fulfills TransCelerate Biopharma’s minimum requirements for the mutual recognition of GCP training for investigators.

All training courses include one year of access to 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

[toggles title="Module:  Introduction"]
You'll learn about the following:

  • The Sponsor and ICH-GCP
  • Principles of ICH-GCP
  • Uniformity to Reliability

[/toggles]

[toggles title="Module:  Trial Set-Up"]
You'll learn about the following:

  • Essential Documents
  • Quality Management
  • Internal Quality Control
  • Quality Assurance

[/toggles]

[toggles title="Module:  Trial Preparation"]
You'll learn about the following:

  • Investigational Product
  • Investigator Selection
  • Trial Subject Information

[/toggles]

[toggles title="Module:  Submission"]
You'll learn about the following:

  • Clinical Trial Review
  • Continued Review

[/toggles]

[toggles title="Module:  Start & Conduct"]
You'll learn about the following:

  • Compliance
  • IP Management
  • Safety, Definitions & Reporting
  • Quality Control

[/toggles]

[toggles title="Module:  Close-Out & Archiving"]
You'll learn about the following:

  • Trial & Site Close-out
  • Archiving

[/toggles]

[toggles title="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

[/toggles]

Additional information

Job Role

, , ,

Language

Level

Phase of Study

, , , , ,

Region of Regulation

Regulation

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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.

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