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Expert Online ICH GCP Course for International Clinical Trials

This course was previously called “Online ICH-GCP training”. Learn everything you need to know to master ICH GCP for international clinical trials via this highly interactive, self-paced, and certified GCP e-learning course. Includes 7 interactive modules.

 175.00

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LEARNING OBJECTIVES

  • Principles of ICH GCP and the ICH GCP Addendum R2
  • Roles in clinical research
  • Abbreviations and terminology
  • Develop trial protocol
  • Selection of research sites and staff
  • Setting quality assurance: monitoring plan, auditing, DSMB, SOPs
  • Essential documents
  • Delivery, randomization, and blinding
  • How to prepare product information
  • How to inform your subjects
  • Compensation and insurance
  • Agreements
  • Review procedures
  • IEC/IRB submission
  • Terms and conditions
  • How to start your study
  • Recruitment of subjects
  • Informing the subjects
  • Requirements for research with vulnerable subjects
  • Safety reports and safety of your subjects
  • Trial amendments
  • Documentation
  • Quality Management
  • Regular study completion
  • Early termination
  • Archiving and close-out

 

DESCRIPTION

The expert course to ICH GCP is the self-paced online training solution for researchers, pharma professionals, and research staff who conduct international clinical trials in ICH regions and need to be aware of the Good Clinical Practice guidelines 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 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 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, 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, 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 myGCP learning modules on your smartphone, tablet, or desktop computer.

 

COURSE CONTENTS

[toggles title=”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

[/toggles]

[toggles title=”Module:  Design”]
You’ll learn the following in this module:

  • Protocol development and content
  • Select research team
  • Selection of investigators and research locations
  • Selection criteria for researchers and research locations
  • Create and store essential documents (Investigator Site File)
  • Risk inventory and assessment
  • Setting up quality assurance: monitoring plan, auditing, DSMB, SOPs

[/toggles]

[toggles title=”Module:  Preparation”]
You’ll learn the following in this module:

  • Packaging, labeling, importing and supplying investigational products
  • Compose product information (Investigator’s Brochure)
  • Draw up patient information and other trial documents
  • Contracts and Agreements
  • Insurance (Trial Insurance and Liability)

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[toggles title=”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

[/toggles]

[toggles title=”Module:  Start”]
You’ll learn the following in this module:

  • Delegate tasks and Initiation Visit
  • Supply, storage, and use of the investigational product in a trial
  • Recruitment of subjects
  • Informing subjects
  • Informed Consent procedure
  • Randomization and coding
  • Privacy of data
  • Requirements for research with vulnerable subjects

[/toggles]

[toggles title=”Module:  Conduct”]
You’ll learn the following in this module:

  • Amendments, deviations, and changes in protocol and trial
  • Adding new research sites and investigators
  • Safety reports (AE / SAE)
  • Safety subjects medical care and DSMB
  • Documentation and data management (source, CRF, database)
  • Monitoring/ Auditing/ Inspection
  • Quality assurance and risk management
  • Progress reports

[/toggles]

[toggles title=”Module:  Archive (Close-out)”]
You’ll learn the following in this module:

  • Regular completion of a trial
  • Preliminary closing of a trial
  • Report end of the study
  • Requirements for final report / Clinical Study Report
  • Storage and archiving trial documentation
  • Retention deadlines for trial documentation

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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 Expert Online ICH GCP Course for International Clinical Trials

  1. matyas@igina.net

    Very useful, great to have links to all documentation. Will keep many of the downloads as reference. Very well explained and touches upon all roles, responsibilities, and steps. Great for a starter.

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