Evidence map›Paper›PMID 35154812›Full record

ArticleJournal of clinical and translational science2022

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

Caterina Caminiti, Giuseppe Maglietta, Ileana Frau, Giulia Peruzzotti, Mariagrazia Felisi, Antoinette van Dijk

Abstract read
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Article in Journal of clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Caterina CaminitiClinical and Epidemiology Research Unit, University Hospital of Parma, Parma, Italy.ORCID https://orcid.org/0000-0002-3196-2435
Giuseppe MagliettaClinical and Epidemiology Research Unit, University Hospital of Parma, Parma, Italy.ORCID https://orcid.org/0000-0003-4497-1872
Ileana FrauSite Relationship Manager (SRM) Site Management, IQVIA, Milan, Italy.
Giulia PeruzzottiClinical Trial Office IEO, European Institute of Oncology IRCCS, Milan, Italy.
Mariagrazia FelisiQuality Assurance Unit, Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy.
Antoinette van DijkClinical & Medical Affairs Unit, D.O. Research Sagl, Lugano, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical 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.

methodsCross-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.

resultsData 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 (

conclusionsThe 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.

Indexed as

Clinical research coordinatordata managerinvestigator-initiated studiesnonclinical research staffresearch infrastructure

Identifiers

PMID35154812
PMCPMC8807122

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.