Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

201724 citationsJournal Articlegold Open Access

Authors

Howard Lee · Seoul National University of Science and Technology

Heechan Lee · Seoul National University of Science and Technology

Jung-Mi Baik · Seoul National University of Science and Technology

Hyunjung Kim · Seoul National University Hospital

Rachel Youkyung Kim · Pfizer (South Korea)

Abstract

FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Topics & Keywords

Ethics in Clinical Research Quality and Safety in Healthcare Statistical Methods in Clinical Trials

Publication Details

Published in: Drug Design Development and Therapy

Volume Volume 11, pp. 3035-3043

DOI: 10.2147/dddt.s145310

Field-Weighted Citation Impact: 1.49

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Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

Authors

Abstract

Topics & Keywords

Publication Details