CONSCIOUS II project outputs:

In the project, e-learning materials will be developed in international collaboration, focusing on practical aspects of planning and organizing clinical trials, complemented by several chapters on interdisciplinary skills. Specifically, the following chapters will be included in the professional part:

- Lifecycle of the Tria
- Trial methodology
- Trial management
- Quality and regulatory affairs and sourcesofregulatoryinformation
- Pharmacovigilance and study medication
- Data management and statisticalanalysis
- Early phase trials
- Pediatric clinical trials
- Medical Devices

and, within the interdisciplinary curriculum, the following chapters:

- Leadership, team management and networking skills in research
- Scientific Publishing and Open Research
- Teaching the teachers: innovative pedagogical methods in health education


What is CONSCIOUS II project?

Curriculum Development of Human Clinical Trials for the Next Generation Biomedical PhD Students and Early Career Researchers in Medicine, Pharmacy and Health Sciences (CONSCIOUS II)

Project Number 2021-1-CZ01-KA220-HED-000023177

CONSCIOUS II is a project aimed at training postgraduate students and early-career researchers in clinical trials. This is where there is a particular weakness in the educational process. The previous CONSCIOUS project partially aimed to fill this gap; however, this project focused on undergraduate students and a more general perspective. In contrast, postgraduate students and junior researchers have pretty different requirements concerning the need, if not necessity, to plan a clinical trial as part of their own research activity. The CONSCIOUS II project is thus complementary, follow-up, and more in-depth. The project will be implemented from 11/2021 to 10/2024.

Jitka Rychlickova –
Joana Batuca -
Gabor L. Kovacs -
Frances Shiely -
Viktoria Nagy -
Annamária Tünde Németh -

Masaryk University (Coordination Lead -Czech Republic)
University of Pécs (Hungary)
University College Cork (Ireland)
Université Paris Cité (France)
Nova University Lisbon(Portugal)
University of Széged (Hungary)

The CONSCIOUS II project is supported by ECRIN, an associated partner and reviewer of the prepared materials, and its national nodes.

All 12 e-learning lessons will be published and made available freely on this learning platform, which 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:

Please find below each Chapter Outline:

Chapter 1- Clinical Trial Design (University College Cork, Cork, Ireland)

Chapter 2- Trial Methodology (University College Cork, Cork, Ireland)

Chapter 3- Trial Management (Nova University Lisbon, Lisbon, Portugal)

Chapter 4- Quality and Regulatory Affairs (Masaryk University, Brno, Czech Republic)

Chapter 5- Pharmacovigilance and Study Medication (University College Cork, Cork, Ireland,
and Masaryk University, Brno, Czech Republic)

Chapter 6- Data Management and Statistical Analysis (University of Pécs, Pécs, Hungary)

Chapter 7- Early Phase Trials (University of Szeged, Szeged, Hungary)

Chapter 8- Paediatric Clinical Trials (Masaryk University, Brno, Czech Republic)

Chapter 9- Medical Devices (University of Szeged, Szeged, Hungary)

Chapter 10- Leadership for PIs (Université Paris Cité, Paris, France)

Chapter 11- Open Research and Scientific Publishing (Université Paris Cité, Paris, France)

Chapter 12- Teaching the Teachers (Université Paris Cité, Paris, France)