Update course for nurses and members of a trial team in clinical trials under the Medicines Act (AMG) and Regulation (EU) No. 536/2014 

Accompany Project Manager Dr.C. Splendt  in her considerations on the planning of her two clinical trials and the preparation of the electronic submission via CTIS. Follow  Investigator Dr. Ryf  in the preparation of a clinical trial according to Regulation (EU) No. 536/2014 - what will be changing, and what needs to be considered? And meet CRA Sabine Kurzler  again, who accompanies the investigational team. This e-learning also provides  interviews with experts for you! 

Our ca. 3.5- to 4-hour, interactive Update course offers you the opportunity to complete the eLearning with your smartphone, tablet, or PC in self-selected intervals. A modular structure and individual, content-related chapters allow you to go through the course at your own pace. We invite you to interact directly at almost 90 points of the course, for example through multiple choice questions, statement questions, polls, assignments and similar activities. Following each interaction, our validated system will provide you with feedback on your answer and will explain the content background in detail. In this way, we offer you an individual learning experience. 

From registration on you will have 4 weeks to complete the course. After successfully completing the exam, you will receive a confirmation of participation. 

Who is this course for? For nurses, trial members and non-medical staff wishing to conduct clinical trials on the basis of the new Regulation (EU) No 536/2014 

What content is delivered? The course content covers the following areas: 

Regulatory requirements:  

• Definitions 
• Low- interventional clinical trial 
• Procedure for applications for clinical trial conduct and subsequent modifications 

Ethical requirements:

•  Clinical trials (a) in incapacitated adults, (b) in pregnant or breastfeeding women, (c) in emergencies. 

Implementation according to EU Regulation 536/2014: 

• Tasks and responsibilities of the Principal Investigator, qualifications and tasks of the members of the investigator team 
• Obtaining informed consent 
• New notification obligations of the sponsor and their meaning for the investigator 
• Changes regarding study documentation (trial master file, study database, archiving) 
• Changes in the handling of adverse events/breaches 
• Procedure for reporting/assessing safety-related information 
• Changes in regulatory oversight (inspections) 
• Publicity of the EU database