Open AccessClinical Research Coordinator and Clinical Research Nurse: education and role at the Clinical Trial Center of Alessandria
Author(s) -
Annalisa Roveta,
Francesca Ugo,
Marta Betti,
Serena Penpa,
Tatiana Bolgeo,
Marinella Bertolotti,
Carolina Pelazza,
Fabio Giacchero,
Denise Gatti,
Roberta Di Matteo,
Costanza Massarino,
Stefania Crivellari,
Antonio Maconi
Publication year - 2021
Publication title -
working paper of public health
Language(s) - English
Resource type - Journals
ISSN - 2279-9761
DOI - 10.4081/wpph.2021.9463
Subject(s) - clinical trial , multidisciplinary approach , nursing , medical education , health care , medicine , political science , pathology , law
The increasing complexity of clinical research makes it indispensable for an Institution that wants to conduct clinical trials to have an Organisational Structure and a dedicated multidisciplinary team. Since 2013, the public Hospital "SS Antonio and Biagio and C. Arrigo" of Alessandria (AO AL) has established a Clinical Trial Center (CTC), that has now become a centralized inter-company sector of the Research and Innovation Department. The CTC is part of the Research Infrastructure with its head office at AO AL and a further office at the Local Health Authority Territorial Hospital "S. Spirito" of Casale Monferrato (ASL AL). The CTC aims to design high standard clinical trials, ensuring better efficiency in their activation, management and data management according to the Good Clinical Practice (GCP) guidelines. Over the years, the CTC has grown and gained professional skills such as the Clinical Research Coordinator (CRC) and the Clinical Research Nurse (CRN), not yet officially recognized by the National Health System. These are skilled professional figures, that have been adequately trained even with post-graduate education through a 1st level Master in "Data Management and Coordination of Clinical Trials" which was activated by the University of Eastern Piedmont in collaboration with AO AL. The number and diversity of the activities carried out by CRCs and CRNs within the CTC has led them to develop a tool that strategically permits to recollect and record the time needed to perform these tasks with the aim of evaluating the different types of activities undertaken and assessing the needs of new staff. The organizational model adopted by the AO AL and the ASL AL through a centralized inter-company CTC represents a unique organizational model in the regional scenario and a peculiarity within the Public Health Authority not as yet recognized as Scientific Institutes for Research, Hospitalization and Healthcare.