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

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What is CONSCIOUS?

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.


Contacts to get full access to the platform:

 

CONSCIOUS II project partners:

  • 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.

 

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 Trial
  • 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

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: http://conscious2.eu/

Please find below each Chapter Outline:

CHAPTER 01 - Clinical Trial Design
CHAPTER 02 - Trial Methodology Research
CHAPTER 03 - Trial Management
CHAPTER 04 - Quality and regulatory affairs and sources of regulatory information
CHAPTER 05 - Pharmacovigilance and study medication
CHAPTER 06 - Data Management and Statistical Analysis - Standartizing, and analyzing generated data
CHAPTER 07 - Early phase trials
CHAPTER 08 - Paediatric clinical trials
CHAPTER 09 - Clinical evaluation and clinical investigations of medical devices
CHAPTER 10 - Leadership, team management and networking skills in research
CHAPTER 11 - Scientific publishing and open research
CHAPTER 12 - Teaching the teachers

The project also plans to pilot international lectures - one lecturer will give lectures to students from different universities and countries. In this way, we want to deepen the cooperation between universities and students. The following pilot lessons are scheduled:

Always Tuesday from 6 PM – 7,30 PM (CET)

  • January 9, 2024 –  a “life class” – introduction of the course, of the team, opening the platform, giving material to students (all partners)
  • January  16, 2024 – Clinical  Trial Designs – Frances Shiely, University College Cork
  • January 23, 2024 – Early Phase Trials – Annamária Németh, University of Szeged
  • January 30, 2024 – Pediatric Clinical Trials – Kateřina Nebeská, Masaryk University
  • February 6, 2024 – Quality and regulatory affairs and sources of regulatory information – Zora
    Čechová, Masaryk University
  • February 13, 2024 – Trial Management – Joana Batuca, Sara Maia, Universidade NOVA de Lisboa
  • February 20, 2024 – Data management and statistical analysis – Gábor Kovács, University of
    Pécs
  • February 27, 2024 – Pharmacovigilance and study medication – Frances Shiely, University College Cork, Lenka Součková, Jitka Rychlíčková, Masaryk University  
  • March 5, 2024 – Trial Methodology – Frances Shiely, University College Cork
  • March 12, 2024 – Medical Devices – Annamária Németh, University of Szeged
  • March 19, 2024 – Leadership for PIs – Viktória
    Nagy, Université Paris Cité
  • March 26, 2024 – Open research and scientific publishing – Viktória Nagy, Université Paris Cité
  • April 2, 2024 – Teaching the teachers  – Viktória Nagy, Université Paris Cité

 

For any updates, please
visit the project website: http://conscious2.eu/ ,
where the invitation, registration, and detailed program

will also appear well in advance.

Are you interested in the project? Would you like to know more? Would you like to receive regular information about planned events and published materials? Would you like to participate in the pilot training?

Do not hesitate to contact us:

PharmDr. Jitka Rychlíčková, Ph.D.,
BCPS, Principal Investigator rychlickova@med.muni.cz

Project website: http://conscious2.eu/

This work by CONSCIOUS II consortium is licensed under CC BY-SA 4.0cc.svg?ref=chooser-v1by.svg?ref=chooser-v1sa.svg?ref=chooser-v1