Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context.

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Title: Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context.
Authors: Napolitano D; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy. Daniele.napolitano@policlinicogemelli.it., Bozzetti M; Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.; Direction of Health Professions, ASST Cremona, Cremona, Italy., Caruso R; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.; Health Professions Research and Evidence Transfer Unit, IRCCS MultiMedica, Sesto San Giovanni, Italy., Guberti M; Nursing and Allied Health Professions, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Frau I; Ass. Prime Site Director, Strategic Site Solutions EMEA - IQVIA, Milan, Italy., Smuck B; Department of Ophthalmology, Ivey Eye Institute, St. Joseph's Health Care, London, ON, Canada., Fiorino G; Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, Rome, Italy., Scaldaferri F; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Laterza L; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Gasbarrini A; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy.; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Mora V; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jun 30. Date of Electronic Publication: 2026 Jun 30.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context.
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  Data: <searchLink fieldCode="AU" term="%22Napolitano+D%22">Napolitano D</searchLink>; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy. Daniele.napolitano@policlinicogemelli.it.<br /><searchLink fieldCode="AU" term="%22Bozzetti+M%22">Bozzetti M</searchLink>; Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.; Direction of Health Professions, ASST Cremona, Cremona, Italy.<br /><searchLink fieldCode="AU" term="%22Caruso+R%22">Caruso R</searchLink>; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.; Health Professions Research and Evidence Transfer Unit, IRCCS MultiMedica, Sesto San Giovanni, Italy.<br /><searchLink fieldCode="AU" term="%22Guberti+M%22">Guberti M</searchLink>; Nursing and Allied Health Professions, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Frau+I%22">Frau I</searchLink>; Ass. Prime Site Director, Strategic Site Solutions EMEA - IQVIA, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Smuck+B%22">Smuck B</searchLink>; Department of Ophthalmology, Ivey Eye Institute, St. Joseph's Health Care, London, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Fiorino+G%22">Fiorino G</searchLink>; Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Scaldaferri+F%22">Scaldaferri F</searchLink>; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Laterza+L%22">Laterza L</searchLink>; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Gasbarrini+A%22">Gasbarrini A</searchLink>; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy.; Centro Malattie dell'Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Mora+V%22">Mora V</searchLink>; Scientific Direction - Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Largo A. Gemelli 1, 00168, Rome, Italy.
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              Text: 2026 Jun 30
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