Page 224 - Safety Risk Management for Medical Devices

CHAPTER 26

Risk Management for Clinical

Investigations

Abstract
Clinical investigations are governed by ISO 14155, which addresses good clinical practice for the
design, conduct, recording, and reporting of clinical investigations carried out on human subjects.
ISO 14155 requires that prior to the execution of clinical trials, the risks associated with clinical trials
be estimated in accordance with ISO 14971.
Keywords: Clinical investigations; risk management; clinical study

In this chapter, we will examine the requirements for risk management in clinical
investigations. Clinical investigations are governed by ISO 14155 [33], which
addresses good clinical practice for the design, conduct, recording, and reporting of
clinical investigations carried out on human subjects (also called participants). ISO
14155 [33] defines Clinical Investigation as a “systematic investigation in one or more
human subjects, undertaken to assess the safety or performance of a medical device.”
Clinical studies are conducted to increase medical knowledge as to how a medical
device performs in humans. Some examples of the reasons for conducting clinical
studies:

• Evaluate the clinical benefits of a medical device in treatment of diseases, syn-
dromes, or conditions in the target patient populations.
• Evaluate the risks associated with the use of a medical device both due to the
medical device itself, and how it would be used in clinical settings.
• Confirm the predicted risks and identify any new Hazards associated with the
use of the medical device.
• Gain insight into uncertainties about the performance of the medical device
in vivo.
• Identify rare complications.
• Examine the performance of the medical device under long-term and wide-
spread use.
• Investigate particular features regarding clinical utility.
• Assess cost/benefit or health outcomes in support of reimbursements.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00026-X All rights reserved. 203