CONSCIOUS
The Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students
Developing educational materials related to human clinical trials for biomedical students
The CONSCIOUS project was developed within the ERASMUS+ programme under the leadership of the University of Pécs and in cooperation with Masaryk University, University College Cork (Ireland), University Nova de Lisboa (Portugal) and University of Paris (France); ECRIN was an associate partner of the project. The subject of the CONSCIOUS project was the development of curricula and e-learning materials for undergraduate biomedical students, with the intention of bridging gaps in the professional curriculum covering the field of clinical studies. The project was successfully completed in 2021.
The CONSCIOUS project has developed 14 e-learning lessons covering the basic knowledge and skills important for understanding and conducting clinical trials.
Topics of e-learning lessons:
| 1. What is a clinical trial? (What is a Clinical Trial?) |
| 2. Why are clinical trials the gold standard? (Why are clinical trials the gold standard?) |
| 3. Case Study: Tuskegee Syphilis (Case Study: Tuskegee Syphilis) |
| 4. Ethics in clinical trials (Ethics in Clinical Trials) |
| 5. What patients should know – informed consent (What patients should know – informed consent) |
| 6. Formulating the research question and defining the research objective (Equipoise; Forming a research question and defining the outcome) |
| Phase 7 of the clinical trial (Clinical trial phases) |
| 8. Phase 3 study designs (Phase 3 Trial Design) |
| 9. Clinical Trial Protocol and Case Report Form (Clinical Trial Protocol & Case Report Form) |
| 10. Numbers… sample size and why it is important; interpretation of results (The numbers… sample size, why it is important, interpreting the results) |
| 11. Medical devices and advanced therapies (Medical Devices and Advanced Therapies) |
| 12. Clinical Trial Management (Trial Management) |
| 13. Adverse events and reporting obligations (Adverse events and reporting responsibilities) |
| 14. Critical appraisal of a randomized clinical trial, or “How to read an article” (Critical appraisal of a randomized clinical trial – “How to read a paper”) |
* All materials are available free of charge within the learning platform. To access the learning platform, simply request one of the authorized persons listed on the project homepage to generate access credentials . The platform extends each chapter with interactive elements and practical examples for knowledge application. In addition to the e-learning materials, teacher’s manuals have been developed to provide support to lecturers who decide to use the e-learning materials in lecturer-led teaching.
Project code: 2018-1-HU01-KA203-047811
Solution period: 1/2019 – 8/2021 (extended to 10/21)
European Union – Erasmus+ Key Action 2: Cooperation on innovation and exchange of best practices; Strategic partnerships in education, training and youth
Faculty / Department of MU: Faculty of Medicine
Principal investigator of the project: doc. MUDr. Regina Demlová, Ph.D.
Cooperating organisations:
- University of Pécs
- University College Cork
- Nova University Lisbon
- University of Paris
Would you like to know more? Do you have an idea for use in teaching or self-study? Do not hesitate to contact us!
PharmDr. Jitka Rychlíčková, Ph.D. | Project manager rychlickova@med.muni.cz
