Data managers and clinical research coordinators: a tool to collect the hourly activity
https://doi.org/10.4081/wpph.2024.9856
Accepted: 21 August 2024
SUPPLEMENTARY PDF: 2
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Background and Aims: the main purpose of this paper is analyzing the hourly activities performed by Data Managers (DMs) and Clinical Research Coordinators (CRCs) in a Clinical Trial Center (CTC) of an Italian Public Hospital in order to define and monitor the relevant job descriptions of these professionals
Materials and Methods: the CTC of the Research and Innovation Departments (DAIRI) has created a tool to collect the hourly activity of DMs and CRCs. In the period between January 1 and December 31, 2022; the activities were collected and grouped in 24 macro areas.
Results: the main activities conducted by staff are found in the macro areas "Study Management" (15.78%); "Briefing/Planning" (12.86%) and “Data Management/Data Entry” (12.42%). A difference was found between the activities carried out by CRCs and those conducted by DMs.
Conclusions: the results of this monitoring, compared with data obtained at the national level, confirm the heterogeneity of the tasks performed by these professional figures. These differences increasingly underscore the need to obtain recognition of the figure by the National Health System (NHS) with the definition of a precise “job description”.
Roveta A, Ugo F, Betti M, et al. Clinical Research Coordinator and Clinical Research Nurse: education and role at the Clinical Trial Center of Alessandria. Working Paper of Public Health. 2021;9:9463. DOI: https://doi.org/10.4081/wpph.2021.9463
Stabellini S. Sperimentazione clinica, le figure coinvolte nello studio. 2017. Available from: https://www.nurse24.it/specializzazioni/ricerca/clinica-figure-conducono-studio.html
Stabile S, Cenna R, Sinno V et al. Clinical trial units and clinical research coordinators: a system facing crisis? AboutOpen. 2023;10:1-3. DOI: https://doi.org/10.33393/ao.2023.2508
Sancheti P, Aiyer S, Sanghavi S, et al. What does a department need to get involved in clinical trials? Injury. 2023;54:S46-50. DOI: https://doi.org/10.1016/j.injury.2023.01.036
Caminiti C, Maglietta G, Frau I, et al. Presence and activities of clinical research coordinators at Italian Health Care Institutions: a national cross-selection survey. J Clin Transl Sci. 2021;6:e1. DOI: https://doi.org/10.1017/cts.2021.872
Fabbri F, Gentili G, Serra P, et al. How Many Cancer Clinical Trials Can a Clinical Research Coordinator Manage? The Clinical Research Coordinator Workload Assessment Tool. JCO Oncology Practice. 2021;17:e68-76. DOI: https://doi.org/10.1200/JOP.19.00386
Agenzia Italiana del Farmaco (AIFA). 20° Rapporto nazionale sulla Sperimentazione Clinica dei medicinali in Italia. 2023. Available from: https://www.aifa.gov.it/documents/20142/241008/20-Rapporto-OsSC_2023.pdf
von Niederhäusern, B, Magnin, A, Pauli-Magnus C. The impact of clinical trial units on the value of clinical research in Switzerland. Swiss Med Wkly. 2018;148:w14615. DOI: https://doi.org/10.4414/smw.2018.14615
Roveta A, Ugo F, Betti M, Maconi A. L’organizzazione di un Clinical Trial Center centralizzato: il modello Alessandria. Recenti Prog Med. 2022;113: 1-2
Società Scientifica di Medicina Interna FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti). La ricerca clinica come investimento per l’italia, dalle parole all’azione - una proposta in 10 punti. 2016. Available from: https://www.fadoi.org/news/la-ricerca-clinica-investimento-litalia-dalle-parole-allazione-proposta-10-punti/
Copyright (c) 2024 Giorgia Piceni, Gabriel Corbo, Carolina Pelazza, Serena Penpa, Marta Betti, Antonio Maconi
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Downloads
Citations
