The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review
Clarifying the roles of CSCs and DMs and implementing structured training and certification programs are essential to improving trial efficiency. While direct evidence of CSC-DM collaboration was limited, included studies indicate that clear role delineation enhances data quality and regulatory compliance.
Authors
- Daniele Napolitano (ORCID: https://orcid.org/0000-0003-2481-5354)
- Shelly Amato (ORCID: https://orcid.org/0009-0003-8296-710X)
- Alessia Leonetti (ORCID: https://orcid.org/0000-0002-7445-8415)
- Francesca Profeta (ORCID: https://orcid.org/0000-0001-5672-1382)
- Antonio Gasbarrini (ORCID: https://orcid.org/0000-0002-6230-1779)
- Amatucci Valeria
- Schiavoni Elisa
- Turchini Laura
- Capodrossi Anna
- Gianluca Ianiro (ORCID: https://orcid.org/0000-0002-8318-0515)
- Caterina Fanali
- Teberino Maria Anna
- Graziani Cristina
- Durini Eleonora
- Eleonora Ribaudi (ORCID: https://orcid.org/0009-0009-4698-0845)
- Vincenzina Mora
- M Manokhina Marina
- E. Foscarini
- Foscarini Elisa
- Elisabetta Creta (ORCID: https://orcid.org/0009-0002-4716-6000)
- Wlderk Giulia
- Savini Roberta
- Fanali Caterina
- Cala’ Palmarino Francesca
- Giordano Luciana
- Vetrone Maria Amelia
- Creta Elisabetta
- Profeta Francesca
- Leonetti Alessia
- Alberelli Maria Adele
- Leonti Gabriela
- Zavarella Maria Antonietta
Institutions
- Università Cattolica del Sacro Cuore (IT)
- Agostino Gemelli University Polyclinic (IT)
- Azienda Ospedaliera San Camillo-Forlanini (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
Publication Details
- Journal
- Clinical Trials
- Published
- 2025-11-20
- DOI
- https://doi.org/10.1177/17407745251387952
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00