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GHTF GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - PDF (355kb)

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representatives and National Competent Authorities (based on GHTF/SG2/N54:2006).

Study Group 2 Final Document GHTF/SG2/N87:2012

Introduction

Important safety information concerning medical devices needs to be communicated

by the fastest, most efficient means. The basic information necessary for medical device

related adverse event reporting has already been agreed between international regulators and

manufacturers representative organisations represented within GHTF Study Group 2 and

issued as a final document GHTF/SG2/N54:2006.

Manufacturer representatives and National Competent Authorities recognise that a

harmonized electronic transfer of adverse event datasets from manufacturers systems to

relevant National Competent Authorities can offer significant efficiency gains and help

improve response times for all concerned parties. It is expected that electronic reporting will

become the method of choice in the future. GHTF has therefore developed this guidance

document to encourage harmonized global development of electronic medical device adverse

event reporting, based on GHTF/SG2/N54:2006.

This document presents an XML schema that has been developed using GHTF SG2

N54:2006. It should allow manufacturers or their authorized representatives and Competent

Authorities to gain experience in the use of the XML schema.

GHTF recommends that those NCAs considering introducing electronic adverse event

reporting facilities for manufacturers should develop systems that use N87, rather than a

completely different data structure. However, it is very likely that national competent

authorities will have to accept reports in other formats (paper form, Word file, email, etc) for

some time into the future.

We recognize that some other electronic data exchange systems exist, therefore

mapping will be required to allow for exchange of data.

1. Scope

This guidance provides details of an electronic format for manufacturers and

Competent Authorities to use when exchanging adverse incident data electronically. The

guidance comprises:

• A rationale for a customised XML schema for manufacturer reporting based on

GHTF/SG2/N54:2006 (this document).

• A spreadsheet giving the field names used in GHTF/SG2/N54:2006 and the field

names and workflow embedded within the XML schema (

XML schema based on N54:2006.xls>)

• An XML schema for manufacturer reporting based on GHTF/SG2/N54:2006. This

consists of four separate electronic files (

initialfinal.xsd; n87-final.xsd) representing the portion of the schema relevant to

initial, follow-up, final and combined initial and final.

The six electronic documents together comprise the GHTF/SG2/N87:2012 guidance

document bundle.

th

July 27 , 2012 Page 4 of 6

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