Duration
20h Th, 10h Pr
Number of credits
| Master in biomedicine, professional focus in clinical research management | 3 crédits |
Lecturer
Language(s) of instruction
English language
Organisation and examination
Teaching in the first semester, review in January
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
A medical device is an instrument, apparatus, equipment, or software intended by its manufacturer to be used in humans for purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of a disease or injury. Depending on the risk associated with the device, clinical trials must be conducted to demonstrate its safety and efficacy. As with pharmacological studies, the design of a clinical study follows several stages and must comply with ethical guidelines and applicable regulations. The objective of this course is to understand how a clinical study on a medical device is conducted and why it is necessary.
The course covers the definition and classification of medical devices, the classification of clinical trials including types (treatment, prevention, diagnostic, screening, genetic, etc.) and phases (I, II, III, IV), as well as study design and safety considerations, including cost-effectiveness, data collection and management, interpretation of results, and participant protection through ethical, safe, and transparent practices, and finally, the regulatory framework governing medical devices.
Learning outcomes of the learning unit
By the end of this teaching unit, the student will be able to define and classify medical devices, explain the different types and phases of clinical trials, understand how a clinical study on a medical device is designed and conducted, assess the safety and efficacy of a device while considering cost-effectiveness, properly collect and manage data, critically interpret results, and apply ethical and regulatory principles to protect participants and ensure transparency in studies.
Prerequisite knowledge and skills
The prerequisites include basic knowledge of statistics, ethical principles in medical research, and a general understanding of health economics and healthcare systems.
Planned learning activities and teaching methods
The teaching is primarily based on ex cathedra lectures presenting the fundamental concepts of medical devices, the phases of clinical trials, and regulatory, ethical, and economic aspects. It is complemented by case studies and small-group discussions to analyze study design, evaluate effectiveness, manage risks, and develop critical reasoning. Students also participate in project presentations simulating the journey of a medical device they have designed, allowing them to apply learned concepts and strengthen the integration of theory and practice. Directed readings, digital resources, and instructional videos further support learning, while quizzes and formative assessments help verify understanding of key concepts. The teaching methods combine an integrative approach, active learning, and the use of multimedia resources, with regular feedback to consolidate mastery of the learning outcomes.
Mode of delivery (face to face, distance learning, hybrid learning)
Blended learning
Further information:
Mode of delivery: face-to-face and distance-learning
Course materials and recommended or required readings
Platform(s) used for course materials:
- eCampus
- MyULiège
- Microsoft Teams
Further information:
Platform(s) used for course materials:
- eCampus
- MyULiège
- Microsoft Teams
Oral examination
Work placement(s)
Organisational remarks and main changes to the course
Languages: English and/or French
Contacts
Philippe Morimont
Liège University Hospital (CHU Liège)
Intensive Care Unit
Cardiovascular Department
Email: philippe.morimont@uliege.be
Secretariat phone: +32 4 3237495