Refresher ICH GCP Course for Clinical Drug Trials in Germany

With the Refresher ICH GCP Course for Clinical Drug Trials in Germany, you update your knowledge of the Sponsor and Investigator responsibilities for clinical trials with medicinal products in Germany. This highly interactive, self-paced, and accredited GCP e-learning course includes 4 interactive modules and has a duration of 3,5 hours. It is available in German and English.

 199.00

Additional information

Job Role

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Language

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Level

Phase of Study

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Region of Regulation

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Category: Tag:

Refresher ICH GCP Course for Clinical Drug Trials in Germany

 199.00

With the Refresher ICH GCP Course for Clinical Drug Trials in Germany, you update your knowledge of the Sponsor and Investigator responsibilities for clinical trials with medicinal products in Germany. This highly interactive, self-paced, and accredited GCP e-learning course includes 4 interactive modules and has a duration of 3,5 hours. It is available in German and English.

Category: Tag:

LEARNING OBJECTIVES

  • Overview of the legal basis for clinical trials with medicinal products in Germany
  • Upcoming changes in German and European legislation (VO (EU) 536/2014)
  • Roles and responsibilities of the sponsor and investigator in the planning and preparation of the trial
  • Obtaining informed consent, documenting relevant trial data, and working according to the trial protocol
  • Patient safety and the assessment and documentation of adverse events, AEs.

DESCRIPTION

The Refresher ICH GCP Course for Clinical Drug Trials in Germany is the self-paced online training solution for clinical research professionals who need to refresh their knowledge of the German legislation (AMG) applicable to clinical drug research with human subjects (Arzneimittelstudien).

This training is required for investigators and research nurses working on Clinical Drug Trials in Germany in line with the "Curriculare Fortbildung gemäß Beschluss der Bundesärztekammer". It is also applicable to CRA's, research coordinators, sponsors, and professionals working at CROs.

This online course is available in German and English and is the best choice for those who like the flexibility of online learning at their own pace and time. It translates the GCP framework to practice and gives you the tools to directly implement the knowledge in your daily practice.

It includes:

  • myGCP Certificate
  • accredited by the Ärztekammer Schleswig-Holstein
  • compliant with the requirements of the German Medical Association ( Bundesärztekammer)
  • Efficient and interactive learning
  • Easy accessible via smartphone, tablet, or desktop
  • Self-paced and modular

The course consists of 4 online training modules and represents a total workload of 4 hours. The modules are divided into chapters of 10 to 40 minutes.

After you have completed all components of the Refresher ICH GCP Course for Clinical Drug Trials in Germany, you will receive a GCP Certificate. This certificate is accredited by the Ärztekammer Schleswig-Holstein and complies with the requirements of the German Medical Association.

All training courses include one year of access to online training. 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 the following in this module:

  • Basis and Definitions
  • Preview on CTR

[/toggles]

[toggles title="Module:  Roles & Responsibilities"]
You'll learn the following in this module:

  • Tasks and Responsibilities
  • Investigator and Team

[/toggles]

[toggles title="Module:  On-Site"]
You'll learn the following in this module:

  • Deviations and Amendments
  • Recruitment of Subjects
  • Documentation

[/toggles]

[toggles title="Module:  Safety"]
You'll learn the following in this module:

  • (S)AEs & Co

[/toggles]

[toggles title="Module: Knowledge Test"]
The knowledge test includes:

  • 10 questions
  • Available in English and German
  • 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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