EU CTR Update Course for Clinical Drug Trials in Germany

Are you an Investigator or Research staff involved in clinical trials with medicinal products in Germany? Prepare for the Clinical Trial Regulation (CTR) as required by the German Medical Association (Bundesärztekammer) with our EU CTR Update Course. This highly interactive, selfpaced and accredited e-learning course includes 4 interactive modules and has a duration of 4 hours.

 229.00

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LEARNING OBJECTIVES

  • Overview of the impact of the CTR on clinical trials with medicinal products in Germany
  • Upcoming changes in German and European legislation (VO (EU) 536/2014)
  • Explanation of the Transition period from Clinical Trials Directive to Regulation starting Januari 31st 2022
  • Explanation of the submission and review process according to the CTR
  • Obtaining informed consent, documenting relevant trial data and working according the trial protocol
  • Patient safety and the assessment and documentation of adverse events, AEs
  • Notification requirements according to Regulation (VO (EU) 536/2014)
  • Working with the Clinical Trials Information System (CTIS)

DESCRIPTION

It is the task of the Principal Investigator to ensure that a clinical trial at his site complies with the EU Clinical Trials Regulation (CTR).

The EU CTR Update Course for Clinical Drug Trials in Germany is the self-paced online training solution for clinical research professionals who need to update their knowledge of the Clinical Trials Regulation. In preparation for the CTR becoming effective, the German Medical Association (Bundesärztekammer) has issued a Curriculum specifically for the CTR. It is expected that all Investigators and Research Nurses active in clinical trials with medicinal products attend this course. For Investigators active in a CTR trial, the ECs will verify the Investigator’s qualification via EU CTR Update certificate review when an application is submitted.

The e-learning is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the CTR framework to practice in German hospitals and gives you the tools to directly implement the knowledge in your daily practice.

  • EU CTR Update Certificate
  • 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 EU CTR Update Course for Clinical Drug Trials in Germany, you will receive a EU CFR Update Certificate. Please note: as only German companies can provide accredited courses, our partner Forschungsdock Akademie provides the e-learning with accreditation for German investigators. Contact us for more information.

All training courses include one-year access to the online training. Enroll now to get started with the online learning modules on your smartphone, tablet or desktop computer.

COURSE CONTENTS

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

  • Decision Tree and Decision at Sponsors
  • Special target groups

[/toggles]

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

  • Preparation of submission / Application
  • Approval of the submission file

[/toggles]

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

  •  Delegation
  • Informed Consent
  • Documentation
  • AEs

[/toggles]

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

  • Substantial amendments
  • Reporting via CTIS
  • Inspections

[/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]

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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