The Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students
Project Number 2018-1-HU01-KA203-047811

The CONSCIOUS project was developed within the ERASMUS+ program under the coordination of the University of Pécs and in collaboration 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. CONSCIOUS intended to tackle the skills gaps and mismatches related to European-level Clinical Trial Professionals through curriculum development and preparation of e-learning material for the career development of biomedical undergraduate students. The project was successfully completed in 2021.

Within the CONSCIOUS project, 14 e-learning lessons have been developed, covering the essential knowledge and skills necessary for understanding and conducting clinical trials.

Topics of e-learning lessons:

1. What is a Clinical Trial?

2. Why are clinical trials gold standard?

3. Case Study: Tuskegee Syphilis

4. Ethics in Clinical Trials

5. What patients should know – informed consent

6. Equipoise; Forming a research question and defining the outcome

7. Clinical trial phases

8. Phase 3 Trial Design

9. Clinical Trial Protocol & Case Report Form

10. The numbers… sample size, why it is important, interpreting the results

11. Medical Devices and Advanced Therapies

12. Trial Management

13. Adverse events and reporting responsibilities

14. Critical appraisal of a randomized clinical trial – “How to read a paper”

All materials are freely available on the learning platform. To access the learning platform, simply ask one of the authorised persons listed on the project homepage to generate your login details. Platform will allow the enrichment of the materials with interactive and application elements. The outlines of the individual chapters can be accessed in turn on the project website.

Project Identification: 2018-1-HU01-KA203-047811

Project Period: 1/2019 – 8/2021 (extended till 10/21)

Investor/Program/Project type: European Union – Erasmus+ Key Action 2: Cooperation for innovation and the exchange of good practices; Strategic Partnerships in the field of education, training and youth

Masaryk University Faculty or unit: Faculty of Medicine

Project Principal Investigator: doc. MUDr. Regina Demlová, Ph.D.

Cooperating Organization:

  • 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 |