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GHTF/SG5/N5:2012 Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)

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标准简介

Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)[附网盘链接]是Study Group 5 of the Global Harmonization Task Force发布的GHTF标准，适用于全球。

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Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)[附网盘链接]
Reportable Events During Pre-Market Clinical Investigations - PDF (196kb)[附网盘链接](截图)

 

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标准部分原文

Study Group 5 Final Document GHTF/SG5/N5:2012

1 Introduction

The objective of adverse event reporting during pre-market clinical investigations is to

improve protection of the health and safety of patients, users and others by identifying safety

issues early in the human use of medical devices so that these can be addressed. These safety

issues can therefore be addressed as soon as possible by modification of the device, revision of

the instructions for use, modification of the clinical investigation plan or withdrawal of the

device from use.

It should be recognized that the requirements for such adverse event reporting should

necessarily be more stringent than post-market vigilance requirements because of the fact that

such medical devices may not have been previously used in humans and are therefore more

likely to be associated with unforeseen physiological or pathological effects.

This document represents a global model, which provides guidance on the types of

adverse events associated with clinical investigations of investigational devices that should be

reported by sponsors to National Competent Authorities (NCAs). It was drafted as a

collaborative effort using the combined expertise of GHTF Study Groups 2 and 5. It incorporates

and supplements existing regulatory requirements existing in the participating member countries

and international standards specifying the planning, conducting and managing of clinical

investigations. However, this guidance may not reflect all current regulatory requirements,

because the present reporting criteria of the participating countries, while similarly intentioned

are not identical. This document therefore provides a model towards which existing systems

should move. The principles laid down in this document should be considered in the

development or amendment of regulatory systems in the participating countries or other

countries.

2 Scope

This guidance aims to set out a uniform system of Adverse Event Reporting globally and

is applicable to pre-market clinical investigations undertaken by, or on behalf of, the

manufacturer to obtain regulatory approval for placing the device on the market and/or pre-

market investigations that require authorization by the relevant regulatory authority prior to

initiation.

This guidance document concerns only adverse events affecting human research subjects

enrolled in the pre-market phase. When the investigational medical device used in a clinical

study is approved in a particular jurisdiction, the NCA of that country shall apply the post-market

reporting requirements. (GHTF/SG2/N54).

This guidance is supported by the requirements provided in ISO 14155 (Clinical

Investigation of Medical Devices for Human Subjects – Good Clinical Practices) and definitions

have been harmonized to ISO 14155 where possible.

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August 10 , 2012 Page 4 of 15

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