RYCHLÍČKOVÁ, Jitka, Joana R BATUCA, Viktória NAGY, Frances SHIELY, Zora ČECHOVÁ, Kateřina NEBESKÁ, Lenka SOUČKOVÁ, Stephane MOULY, Gábor L. KOVÁCS, Annamária NÉMETH, Tiago OLIVEIRA, Marco PAINHO, Sara MAIA and Emília C. MONTEIRO. Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects. In ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science. 2023.
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Basic information
Original name Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects
Name in Czech Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects
Authors RYCHLÍČKOVÁ, Jitka (203 Czech Republic, guarantor, belonging to the institution), Joana R BATUCA (620 Portugal), Viktória NAGY (250 France), Frances SHIELY (372 Ireland), Zora ČECHOVÁ (203 Czech Republic, belonging to the institution), Kateřina NEBESKÁ (203 Czech Republic, belonging to the institution), Lenka SOUČKOVÁ (203 Czech Republic), Stephane MOULY (250 France), Gábor L. KOVÁCS (348 Hungary), Annamária NÉMETH (348 Hungary), Tiago OLIVEIRA (620 Portugal), Marco PAINHO (620 Portugal), Sara MAIA (620 Portugal) and Emília C. MONTEIRO (620 Portugal).
Edition ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science, 2023.
Other information
Original language English
Type of outcome Presentations at conferences
Field of Study 30104 Pharmacology and pharmacy
Country of publisher Czech Republic
Confidentiality degree is not subject to a state or trade secret
WWW URL
RIV identification code RIV/00216224:14110/23:00130592
Organization unit Faculty of Medicine
Keywords in English clinical trials
Tags rivok
Tags International impact
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 12/1/2024 13:52.
Abstract
Investigator-initiated clinical trials (IIT) are a broadly interprofessional field that is becoming increasingly relevant to biomedical postgraduate students, especially to validate their research question in clinical practice. Indeed, IIT represent a way to develop individualized treatment and obtain objective evidence to answer questions of day-to-day practice. On the other hand, IIT place greater demands on investigators as they extend their position to include the coordination and management role of the sponsor. At the same time, little formal training in clinical trials is available across European countries in both undergraduate and postgraduate education, and the understanding of biomedical graduates in clinical research organization may not be optimal. A consortium of six European universities was established to fill this gap by preparing a highly practice-based and -oriented curriculum within two consequent projects – CONSCIOUS and CONSCIOUS II. Especially the CONSCIOUS II is focused on postgraduate students and provides them with e-learning lessons of practical guidance on how to design a research question and a clinical trial, the regulatory requirements that need to be met, how to conduct the trial, what activities can be delegated, and how to analyze the results. The second part targets transdisciplinary skills such as leadership, publishing, and teaching. The CONSCIOUS II pedagogical approach moves on to contextualized, case-based exercises allowing to test the acquired skills in simulated situations. Both CONSCIOUS projects thus offer a comprehensive, free-of-charge curriculum for biomedical students but will also open a pilot course with international participation as a further extension of this curriculum.
Links
LM2023049, research and development projectName: Český národní uzel Evropské sítě infrastruktur klinického výzkumu
Investor: Ministry of Education, Youth and Sports of the CR
2021-1-CZ01-KA220-HED-000023177, interní kód MUName: 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 (Acronym: CONSCIOUS 2)
Investor: European Union, Strategic Partnerships in the field of education, training and youth
PrintDisplayed: 27/6/2024 12:54