Role studijního koordinátora v klinickém výzkumu ve zdravotnických zařízeních – popelka mezi experty v klinických studiích?

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Title in English The role of the study coordinator in clinical research in healthcare facilities – a Cinderella among experts in clinical trials?
Authors

SELVEKEROVÁ Šárka HANÁKOVÁ M. DEMLOVÁ Regina NEBESKÁ Kateřina KRIST H. DUŠEK M. PUŠKAŘOVÁ N. NEVOLOVÁ P. BRANDEJSOVÁ P. DOLEŽALOVÁ H. CVIKLIKOVÁ K. KREMPOVÁ J.

Year of publication 2024
Type Article in Periodical
Magazine / Source Klinicka Farmakologie a Farmacie
MU Faculty or unit

Faculty of Medicine

Citation
web https://klinickafarmakologie.cz/pdfs/far/2024/03/06.pdf
Doi http://dx.doi.org/10.36290/far.2024.020
Keywords study coordinator; clinical studies; education; healthcare facilities
Description The article aims to map the current position of the study coordinator in healthcare institutions in the Czech Republic. The main objective is to raise awareness of the activities that study coordinators perform and to identify their training needs. The study also examines the demand for a formal training program that would support the professional development of this key role in clinical research. The results of two questionnaire surveys, in which 42 healthcare institutions and 120 study coordinators actively participated, show that only 45% of institutions have a formalized clinical studies department. Approximately 40% of study coordinators are classified into non-healthcare categories, which complicates their corresponding job classification. Study coordinators lack a comprehensive system of undergraduate and postgraduate education. The conclusions emphasize the need for formalization of this job position, including the creation of a professional organization that would unify methodological guidelines and strengthen institutional support for study coordinators.
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