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. 2021 Oct 28;6(1):e1.
doi: 10.1017/cts.2021.872. eCollection 2022.

Presence and activities of clinical research coordinators at Italian Health Care Institutions: A national cross-sectional survey

Caterina Caminiti  1 , Giuseppe Maglietta  1 , Ileana Frau  2 , Giulia Peruzzotti  3 , Mariagrazia Felisi  4 , Antoinette van Dijk  5
Affiliations

Presence and activities of clinical research coordinators at Italian Health Care Institutions: A national cross-sectional survey

Caterina Caminiti et al. J Clin Transl Sci. .

Abstract

Background: Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers' research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.

Methods: Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.

Results: Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29-205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2-9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (P = 0.01), but not with the total number of studies, geographical location, or institution type.

Conclusions: The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.

Keywords: Clinical research coordinator; data manager; investigator-initiated studies; nonclinical research staff; research infrastructure.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1.
Fig. 1.
Box plot displaying the distribution of the number of data managers/clinical research coordinators employed in 2019. The box depicts the interquartile range (first to third quartiles) and the median (second quartile, line in bold). Outliers are represented by dots.
Fig. 2.
Fig. 2.
Polar plot representing the frequency with which each of the 13 activities at the centers is performed by the data managers (DM; blue line) or the clinical research coordinators (CRC; yellow line). The furthest lines are from the center, the most frequently activities are performed by the data managers or clinical research coordinator.
Fig. 3.
Fig. 3.
Plots representing the interaction between for-profit and overall studies on the number of clinical research coordinators (CRCs). Each plot depicts the relationship (regression line, and blue area as confidence intervals) between the number of total studies (X axis) and the number of CRCs (Y axis). The five plots are distinguished by the incremental number of for profit studies.
See this image and copyright information in PMC

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