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

SUBMITTER: Franchina V 

PROVIDER: S-EPMC10313875 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature