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 module

Learning objectives

Knowledge

• Understand theoretical and practical issues relating to clinical trials essential for translational medicine and drug/medical device development

Skills

• 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.

Competences

• 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.

Exam

Exams

Name of exam	Clinical Trials
Type of exam	Oral exam based on a project
ECTS	15
Assessment	7-point grading scale
Type of grading	External examination
Criteria of assessment	As stated in the Join Programme Regulations.

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.