Prerequisite/Recommended prerequisite for
participation in the module
Participation in all exams of the 1. semester.
Content, progress and pedagogy of the
module
Learning objectives
Knowledge
- Describe the legal framework of translational medicine
- Describe the regulatory process, including Good Clinical
Practice, Good Laboratory Practice and Good
- Distribution Practice (GCP, GLP, GDP).
- Discuss the institutions and factors governing the conduct of
research (legislation, boards, and guidelines)
- Explain the Danish requirements for and process of obtaining
approval of experiments with animals and with humans, in
particular relating to drug testing
- Discuss the interests and needs of healthy and ill subjects in
research
- Reflect on the concept “conflicts of interests” in terms of
researchers and other actors (e.g. manufacturing companies,
contract research companies, and patient organisations)
- Discuss the issue of access to research results and research
data
- Discuss the concept “scientific fraud” and the related
institutions in public and private research
Skills
- Explain the role of the end user
- Identify actors and their driving forces in research
- Suggest how Good Clinical Practice, Good Laboratory Practice,
Good Distribution Practice can be implemented in a specific
experiment/research project or manufacturing process
- Relate Good Manufacturing Practice to the work with
research
- Discuss the importance of following
Competences
- Provisionally plan a (small) research project concerning
approval, conduct and ethical considerations
- Analyze case studies of clinical trials
Exam
Exams
Name of exam | Regulatory and Ethical Aspects of Clinical Research |
Type of exam | Written exam |
ECTS | 5 |
Assessment | 7-point grading scale |
Type of grading | Internal examination |
Criteria of assessment | The criteria of assessment are stated in the Examination
Policies and Procedures |
Additional information
Please contact
the
programme student counsellors if you consider applying to
the education and you have questions.
Please consult the Moodle page for your semester and contact the
semester coordinator if you have academic questions, or the study
secretary if you have administrative questions.
All other enquiries may be directed to
Helene
Nørgaard, secretary of the Study Board.