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GHTF Releases Guidance on Adverse Event Data Reporting Standard

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By Alexander Gaffney

The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard.

The non-binding guidance document, N87: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (NCAs), was developed by GHTF's post-market surveillance and vigilance study group two (SG2) and released to the public on 1 August.

GHTF writes in the guidance that it is important to be able to transmit safety data information about adverse events, "By the fastest, most efficient means," and notes its N54:2006 document already represents the international standard for adverse event reporting.

Harmonized Approach Has Broad Benefits

Because numerous international regulatory bodies have an interest in adverse events regardless of where they occur, a harmonized approach allows these entities to recognize significant gains in speed, safety and efficiency relative to a haphazard, piecemeal approach to safety reporting.

"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," observed GHTF. "We recognize that some other electronic data exchange systems exist, therefore mapping will be required to allow for exchange of data."

GHTF's preferred method of adverse event reporting relies upon what is known as XML: extensible markup language, a data format that allows customized organization and exchange methods. This allows each regulatory authority to organize data in the way most useful for its own purposes while only requiring manufacturers to use a single XML format for reporting, rather than filling out different forms for each regulatory authority.

The guidance is paired with several spreadsheets instructing sponsors on how to comply with the guidance and how to create XML data fields.




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