Data managers and clinical research coordinators: a tool to collect the hourly activity


Submitted: 21 September 2023
Accepted: 21 August 2024
Published: 13 November 2024
Abstract Views: 83
PDF: 27
SUPPLEMENTARY PDF: 7
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Authors

  • Giorgia Piceni Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy. https://orcid.org/0009-0002-9083-0376
  • Gabriel Corbo Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
  • Carolina Pelazza Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
  • Serena Penpa Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
  • Marta Betti Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy. https://orcid.org/0000-0002-1372-6666
  • Antonio Maconi Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI) - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy. https://orcid.org/0000-0002-1904-7277

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/

Piceni, G., Corbo, G., Pelazza, C., Penpa, S., Betti, M., & Maconi, A. (2024). Data managers and clinical research coordinators: a tool to collect the hourly activity . Working Paper of Public Health, 12(1). https://doi.org/10.4081/wpph.2024.9856

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