ISO 9001:2015 standard implementation in clinical trial centers: An exploratory analysis of benefits and barriers in Italy

V Franchina; S Stabile; R Cenna; F Mannozzi; I Federici; S Testoni; V Sinno; C Cagnazzo

doi:10.1016/j.conctc.2023.101104

ISO 9001:2015 standard implementation in clinical trial centers: An exploratory analysis of benefits and barriers in Italy

Contemp Clin Trials Commun. 2023 Mar 11:33:101104. doi: 10.1016/j.conctc.2023.101104. eCollection 2023 Jun.

Authors

V Franchina^{1

2}, S Stabile^{3

2}, R Cenna⁴, F Mannozzi^{5

2}, I Federici^{6

2}, S Testoni^{5

2}, V Sinno², C Cagnazzo^{7

2}

Affiliations

¹ U.O.C. Oncologia Medica, A.O. Papardo Messina, Italy.
² Gruppo Italiano Data Manager - Coordinatori di Ricerca Clinica, Meldola, Italy.
³ Niguarda Cancer Center, Dipartimento di Ematologia ed Oncologia Struttura Complessa Oncologia Falck Milano, Italy.
⁴ Pharma quality Europe, Reggello, Italy.
⁵ Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Italy.
⁶ Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Italy.
⁷ Unità di Ricerca e Sviluppo Clinico, S.C. Oncoematologia Pediatrica - AOU Città della Salute e della Scienza, Presidio Ospedaliero Infantile Regina Margherita, Torino, Italy.

Abstract

Background: In the last decade many clinical research centers in Italy have increasingly implemented and improved their quality standards and effectiveness of processes through the adoption of a quality management system also according to the certification ISO 9001:2015.

Objective: The aim of this project is to evaluate expected benefits and barriers of ISO 9001 certification for a Clinical Trial Center.

Material and methods: On April 2021, the Italian Group of Data Manager and Clinical Research Coordinator spread an anonymous online survey to healthcare professionals operating in clinical research and quality management systems at research sites.

Results: Reported benefits of ISO oriented Quality Management System adoption include continual improvement and better-quality processes (73.3%), assuring corrective actions (63.6%), planning internal audits (60.2%) and risk management approach (60.7%). The most important barriers to QMS implementation are increased logistical and/or organizational activities (40.9%) and insufficient training on quality programs (29.5%).

Conclusions: Implementing a quality management system represents a challenge for the Clinical Trial Center and helps to improve quality standards and risk management approach. The use of electronic tools is poor and could be increased in the future. Lastly, improvement of continuous QMS trainings should be necessary for updating professionals and optimizing activities within the Clinical Trial Center.

Keywords: Benefits; Good clinical practice; ISO; Processes; Quality; Quality standards.