Refresher course for study nurses and members of an investigational team in clinical trials according to the German Medicines Act, the AMG (curricular training in accordance with the decision of the German Medical Association). 

Our approximately 3.5-hour, interactive refresher offers you the opportunity to take the online course on your smartphone, tablet or PC, whenever and wherever. A modular structure and the associated division into content chapters enables an individual learning experience at your own pace. After successfully completing the final test, you will receive a myGCP Certificate. 

Important to know: The eLearning is compliant with the requirements of the German Medical Association (Bundesärztekammer). 

• 5 hours
• 4 modules (Introduction, Roles & Responsibilities, On site, Safety)
• Knowledge test with 10 questions and 3 attempts
• Available in German and English
• Accreditation
• Foccused on clinical trials in Germany
• Online certificate with a testscore of 80 or higher

Who is this course for? For study nurses and members of a test group who conduct clinical trials in Germany and need a refresher course (e.g. regularly due to sponsor requirements or after a long break in conducting clinical trials) and employees of sponsors and CROs. 

What content is covered? Based on the curriculum, the course content covers the following areas:

• Basics (ethical basics, definitions and scope) 
• Planning and preparation of a clinical study (responsibility, tasks and their assignment in the team, interfaces, resource planning) 
• Study implementation in the test center (patient inclusion, education, study implementation in accordance with the protocol, documentation, adverse events, monitoring, amendments) 
• Brief regulatory outlook on Regulation (EU) 536/2014