- in B.Sc Applied Biology, 4th Semester
- 3h/week (2L/1S) Credits: 3 ECTS
- 6h/week (2L/2S/2P) Credits: 6 ECTS
Clinical research plays an essential role for the translation of biomedical research into daily medical practice. For instance, clinical research provides the evidence for approval of new pharmaceuticals, medical devices or new therapies. Thereby, the execution of clinical trials is highly complex and highly regulated. This module will provide you with an overview of the applications, execution and regulation in the highly relevant field of clinical research as well as the fundamentals of trial design. Knowledge of trial design is not only essential to plan and analyses clinical trials, but is also highly relevant for enhancing the quality of experiments in biomedical research.
- The lecture, seminars and practical course will provide you with a general understanding of methodology, responsibilities, and terminology in the field of clinical research.
- You know the basics understanding of trial design as well as info structure of clinical trials.
- You will have an understanding of the regulatory and ethical framework for the implementation of study trails including the essential documents and requirements.
- You can also use the module to improve the presentation skills
- Basics and methods in clinical research and clinical trial design
- Overview of regulations, including ethical guidelines and Good clinical practice (GCP)
- Details implementation of studies such as info structure and reporting
- Introduction to applied topics of clinical trials such Clinical trials in Drug development or Medical Device Development, Phase IV studies, Epidemiology and New Trends in Clinical Trials
- In the seminar focuses will be on the regulatory and ethical framework for clinical research.
- In addition students will present details of clinical research in different therapeutic areas (e.g. Cardiology, Oncology, Haematology)
- Students will learn practical implement regulation and methodology in a clinical trial simulation
Written Examination: 40%
Presentation 20 %
Contribution at the Exercise ( including Study Report & Monitoring Report) 40%