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.
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
Module: Introduction
- Basis and Definitions
- Preview on CTR
Module: Roles & Responsibilities
- Tasks and Responsibilities
- Investigator and Team
Module: On-Site
- Deviations and Amendments
- Recruitment of Subjects
- Documentation
Module: Safety
- (S)AEs & Co
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
Additional information
| Job Role | Clinical Trial Site Staff, Research Coordinator, Research Nurse |
|---|---|
| Language | |
| Level | |
| Phase of Study | Close-out, Conduct, Design, Preparation, Review, Start, Submission |
| Region of Regulation | |
| Regulation |
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