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In-Company Blended ICH GCP Course for International Clinical Trials

This course was previously called “Blended ICH-GCP training In-Company”. In this mix of self-paced e-learning and a live online training tailor-made to your company’s needs, your team will learn everything they need to know to master ICH-GCP applicable to the execution of international clinical trials. Includes 7 interactive e-learning modules and 1 live online training sessions of 4 hours. The ideal solution for teams.

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  • 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



The expert in-company blended ICH GCP course for International clinical research is the optimal mix for companies: your team learns about GCP guidelines online, at their own pace, and applies the GCP rules to company-specific situations in an instructor-led (virtual) classroom session at your company.

The self-paced online course gives a practical understanding of the ICH GCP guidelines in a logical order: from design to the closeout of clinical trials. After completion of the 7 modules of the online course, the attendees 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. They are challenged to apply their GCP knowledge to solve company-specific case studies. They will exchange knowledge and experiences with their colleagues and have in-depth discussions with the experienced trainer to maximize their learning experience.

This course is ideal for teams working in the clinical research industry in the international ICH regions and experienced staff looking for an extensive update on ICH GCP.

The completion of the training takes 10 hours, including 6 hours of online learning and a virtual* classroom session of 4 hours. (*We provide virtual classroom training due to corona restrictions)

After the attendees have completed all components of the blended ICH GCP course, they will receive a GCP Certificate, recognized by Transcelerate.

All training courses include one-year access to online training. With our continuous learning model, we will keep your team up-to-date with changing regulations and guidelines.



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: 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

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)

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

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

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

Module: Close-Out (Archiving)

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

Module: (Virtual) classroom session (tailor-made)

You’ll learn the following in this module:

  • Apply GCP knowledge to company-specific situations and case studies
  • Discuss remaining questions with the trainer and colleagues
  • Get detailed insights into topics of interest or specific company policies

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 In-Company Blended ICH GCP Course for International Clinical Trials

  1. matyas@igina.net

    This was a very helpful training, in that it gave me an in-depth understanding of all the necessary aspects of the ICH GCP related to my profession.

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