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
Module: Sponsor activities
- Decision Tree and Decision at Sponsors
- Special target groups
Module: Application process
- Preparation of submission / Application
- Approval of the submission file
Module: On site
- Delegation
- Informed Consent
- Documentation
- AEs
Module: Formalities
- Substantial amendments
- Reporting via CTIS
- Inspections
Module: Knowledge Test
- 10 questions
- Available in English and German
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher
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