Evidence map›Paper›PMID 40836948›Full record

ArticleContemporary clinical trials communications2025

DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations.

Susanna Yedro, Elena Tinari, Daniele Napolitano, Giulia Wlderk, Eleonora Ribaudi, Luciana Giannone, Gianluca Ianiro, Mattia Bozzetti, Antonio Gasbarrini, Vincenzina Mora

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

10 authors.

Susanna YedroCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Elena TinariCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Daniele NapolitanoCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Giulia WlderkCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Eleonora RibaudiCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Luciana GiannoneCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Gianluca IaniroCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Mattia BozzettiASST Cremona, Cremona, Italy.
Antonio GasbarriniCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Vincenzina MoraCEMAD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency. Methods: An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions. Results: A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles. Conclusion: Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.

Indexed as

“Clinical study coordinator”"Clinical trials""Contract research organizations"“Data manager"

Identifiers

PMID40836948
PMCPMC12361625

What OpenQuestion holds

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Registered trials

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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.