Update course on Regulation (EU) 536/2014 ("Clinical Trial Regulation") according to the curriculum of the German Medical Association

Finally - also available as eLearning! Prepare yourself for the new regulations at your own pace – using our self-directed eLearning on your smartphone, tablet, or PC!

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 eLearning also provides  interviews with experts for you!

Our interactive update course can be started, interrupted, and resumed anytime, anywhere. A modular structure and the associated division into chapters with grouped content enable an individual learning experience. From registration on, you will have 4 weeks to complete the course. After successfully finishing the knowledge test, you will receive a certificate of attendance.

Important to know: Our course complies with the requirements of the Federal Medical Association (Bundesärztekammer) for curricular training!

The course was accredited with 8 training points in category I by the Medical Association (Ärztekammer) of Schleswig-Holstein and meets the requirements of the Federal Medical Association for eLearnings.

Whom is this course for? For investigators who wish to conduct or manage clinical trials under the new EU Regulation No. 536/2014 (Clinical Trial Regulation).

What content is conveyed?  The modular structure and course content are shown below:

Module 1 - Sponsor Activities

• Chapter 1: The Scope of the CTR
• Chapter 2: Vulnerable Subjects

Module 2 - Application

• Chapter 1: Preparation of the Application
• Chapter 2: Approval of the Submission

Module 3 - On Site

• Chapter 1: On Site
• Chapter 2: Informed Consent
• Chapter 3: Documentation
• Chapter 4: Adverse Events

Module 4 - Formalities

• Chapter 1: Substantial Modifications
• Chapter 2: Reporting Responsibilities
• Chapter 3: Inspections