DISYNCRO：临床研究协调员和数据管理人员的感知角色：来自合同研究组织专业人员的网络调查结果

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-08-07 DOI:10.1016/j.conctc.2025.101533

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

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引用次数: 0

摘要

临床试验的发展使得在研究过程中引入临床研究协调员（CSC）和数据经理（DM）等特定角色变得至关重要。他们的职责有时会重叠，在工作场所产生操作上的挑战。本研究旨在确定合同研究组织（cro）的人员如何感知CSC和DM角色之间的差异，评估其功能重叠，并确定需要更明确角色和培训以提高运营效率的领域。方法采用在线调查工具，通过网络问卷向CRO专业人员收集数据。该调查收集了社会人口统计数据，包括18项知识评估和9项角色责任部分。采用基于Rasch模型的项目反应理论（IRT）分析将被试分为三个能力组。McNemar检验和非参数检验分析了知识差异和知觉矛盾。结果共有122名参与者完成了调查。大多数参与者（98.4%）认为CSC是研究中心的主要人物，77.9%的人认为CSC对临床试验的执行至关重要。在职能重叠方面，57.4%的被访者认为公务员事务局可以履行委员的职责，而只有42.6%的被访者认为委员可以承担公务员事务局的职责。知识水平较低的参与者表现出更高的矛盾反应率，表明更难以区分这两个角色。结论：研究结果显示了对CSCs的压倒性偏好，CSCs在管理临床试验中发挥着关键的多功能作用。对CSCs和dm的不同职责的理论认识不足，影响了操作效率。建立统一的标准培训项目对于定义角色、加强团队合作和提供高质量的临床研究实践至关重要。

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

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.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.