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Background <p>The increasing complexity of clinical trials has emphasized the need for specialized professionals supporting site-based activities. Clinical Research Coordinators (CRCs) and Study Nurses (SNs) play essential roles in ensuring data quality, regulatory compliance, and operational efficiency. However, limited evidence exists on how professionals with cross-site oversight, Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs), perceive their impact. This study explored CRA and CTM perceptions of CRC and SN roles within Italian clinical research sites.</p> Methods <p>A nationwide, multicenter, cross-sectional survey was conducted among CRAs and CTMs working in Italy. Data were collected through a self-administered online questionnaire (September-October 2024) including multiple-choice items and 42 Numerical Rating Scale (NRS, 0–10) questions assessing perceptions of site operations and professional roles. Descriptive and inferential analyses (Chi-square and T-tests) were performed using SAS 9.4, with <i>p</i> &lt; 0.05 considered significant.</p> Results <p>Sixty-six valid responses were analysed (CRAs 87.9%; CTMs 12.1%), mainly from Contract Research Organizations (71.2%). CRCs were perceived as highly impactful (NRS ≥ 8) for data entry (84.8%), remote monitoring (81.8%), and audit/inspection management (80.3%). CTMs assigned significantly higher scores than CRAs for budget/contract management, study start-up, and regulatory documentation (<i>p</i> &lt; 0.05). SNs were perceived as more limited in scope, with higher impact in biological sample management (63.6%) and adherence to study procedures (51.5%). Key factors enhancing monitoring effectiveness included CRC presence (92.4%), adequate workspace (90.9%), and electronic medical record access (86.4%).</p> Conclusions <p>Despite de limitation and the exploratory nature of the study, CRCs are recognized by CRAs and CTMs as critical contributors to site efficiency and monitoring quality, while SNs are valued mainly for patient-related activities. Divergent perceptions reflect distinct professional roles but converge on the need for structured site organization, clearer role definitions, and enhanced infrastructural support to strengthen clinical trial performance.</p>

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Perceived Impact of Site Personnel and Infrastructure on Monitoring Quality in Clinical Trials: a Survey of Italian CRA/CTM Professionals

  • 期刊论文

  • 发表日期：

    2026年6月18日

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  • Stefano Stabile,
  • Sara Testoni,
  • Emanuela Scarpi,
  • Veronica Franchina,
  • Francesca Mannozzi,
  • Marta Betti,
  • Alessandra Ferrari,
  • Celeste Cagnazzo

摘要

Background

The increasing complexity of clinical trials has emphasized the need for specialized professionals supporting site-based activities. Clinical Research Coordinators (CRCs) and Study Nurses (SNs) play essential roles in ensuring data quality, regulatory compliance, and operational efficiency. However, limited evidence exists on how professionals with cross-site oversight, Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs), perceive their impact. This study explored CRA and CTM perceptions of CRC and SN roles within Italian clinical research sites.

Methods

A nationwide, multicenter, cross-sectional survey was conducted among CRAs and CTMs working in Italy. Data were collected through a self-administered online questionnaire (September-October 2024) including multiple-choice items and 42 Numerical Rating Scale (NRS, 0–10) questions assessing perceptions of site operations and professional roles. Descriptive and inferential analyses (Chi-square and T-tests) were performed using SAS 9.4, with p < 0.05 considered significant.

Results

Sixty-six valid responses were analysed (CRAs 87.9%; CTMs 12.1%), mainly from Contract Research Organizations (71.2%). CRCs were perceived as highly impactful (NRS ≥ 8) for data entry (84.8%), remote monitoring (81.8%), and audit/inspection management (80.3%). CTMs assigned significantly higher scores than CRAs for budget/contract management, study start-up, and regulatory documentation (p < 0.05). SNs were perceived as more limited in scope, with higher impact in biological sample management (63.6%) and adherence to study procedures (51.5%). Key factors enhancing monitoring effectiveness included CRC presence (92.4%), adequate workspace (90.9%), and electronic medical record access (86.4%).

Conclusions

Despite de limitation and the exploratory nature of the study, CRCs are recognized by CRAs and CTMs as critical contributors to site efficiency and monitoring quality, while SNs are valued mainly for patient-related activities. Divergent perceptions reflect distinct professional roles but converge on the need for structured site organization, clearer role definitions, and enhanced infrastructural support to strengthen clinical trial performance.