Prerequisite/Recommended prerequisite for
participation in the module
1st semester, Master of Science in Medicine with Industrial
Specialization, Profile: Translational Medicine.
Content, progress and pedagogy of the
- Understand theoretical and practical issues relating to
clinical trials essential for translational medicine and
drug/medical device development
- Apply a set of principles and methods at any stage from design
to conduction and reporting a clinical trial at any phase from
phase I to phase IV.
- Obtain experience in any relevant area within the concept of
clinical trials such as design, setting outcomes, use of
appropriate statistical methods, application of rules and
guidelines to conduct and monitor a trial, report of post-marketing
drug surveillance, adverse reactions, pharmacovigilance, and the
role of media and pharmacoeconomics.
- Select methodology appropriate to the chosen field and problem
within translational medicine
- Collect, critically analyze and interpret data.
- Utilize guidelines, standards, tools, and approaches for
assessing safety and efficacy of drugs/medical devices
considering global benefits to people and economies.
|Name of exam||Clinical Trials|
|Type of exam|
Oral exam based on a project
|Assessment||7-point grading scale|
|Type of grading||External examination|
|Criteria of assessment||As stated in the Join Programme Regulations.|
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
Nørgaard, secretary of the Study Board.