The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance
Identifieur interne : 001125 ( Istex/Corpus ); précédent : 001124; suivant : 001126The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance
Auteurs : N. Moore ; D. Montero ; R. Coulson ; F. De Abajo ; C. Kreft-Jais ; A. Biron ; J. L. MonteagudoSource :
- Pharmacoepidemiology and Drug Safety [ 1053-8569 ] ; 1994-05.
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Abstract
The development of telematic exchange of information in pharmacovigilance has as a consequence the necessary development of the messages used to transmit the information. The first of these messages is the one used to transmit information on individual case reports. Common formats exist on paper, but these have not been applied to electronic transmission. A structured message for the transmission of single case information has been developed within the ENS European research programme, by three National Pharmacovigilance administrations, and reviewed by the relevant European bodies. It has been submitted to the Western European Edifact Board MD9 for admission as an EDIFACT message, so that it will be possible to exchange information concerning these single cases, using standard EDI methodology.
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DOI: 10.1002/pds.2630030306
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<mods version="3.6"><titleInfo lang="en"><title>The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance</title>
</titleInfo>
<titleInfo type="abbreviated" lang="en"><title>THE SINGLE CASE FORMAT</title>
</titleInfo>
<titleInfo type="alternative" contentType="CDATA" lang="en"><title>The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance</title>
</titleInfo>
<name type="personal"><namePart type="given">N.</namePart>
<namePart type="family">Moore</namePart>
<affiliation>French Pharmacovigilance System, Agence du Médicament, France</affiliation>
<description>Correspondence: CHU de Rouen, 76031 Rouen Cedex, France</description>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">D.</namePart>
<namePart type="family">Montero</namePart>
<affiliation>Instituto de Salud Carlos III, Madrid, Spain</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">R.</namePart>
<namePart type="family">Coulson</namePart>
<affiliation>Medicines Control Agency, London, UK</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">F.</namePart>
<namePart type="family">De Abajo</namePart>
<affiliation>Instituto de Salud Carlos III, Madrid, Spain</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">C.</namePart>
<namePart type="family">Kreft‐Jais</namePart>
<affiliation>French Pharmacovigilance System, Agence du Médicament, France</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">A.</namePart>
<namePart type="family">Biron</namePart>
<affiliation>French Pharmacovigilance System, Agence du Médicament, France</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">J. L.</namePart>
<namePart type="family">Monteagudo</namePart>
<affiliation>Instituto de Salud Carlos III, Madrid, Spain</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<typeOfResource>text</typeOfResource>
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<originInfo><publisher>John Wiley & Sons, Ltd.</publisher>
<place><placeTerm type="text">Chichester</placeTerm>
</place>
<dateIssued encoding="w3cdtf">1994-05</dateIssued>
<dateCaptured encoding="w3cdtf">1994-03-31</dateCaptured>
<dateValid encoding="w3cdtf">1994-05-19</dateValid>
<copyrightDate encoding="w3cdtf">1994</copyrightDate>
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<language><languageTerm type="code" authority="rfc3066">en</languageTerm>
<languageTerm type="code" authority="iso639-2b">eng</languageTerm>
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<extent unit="figures">1</extent>
<extent unit="references">5</extent>
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<abstract lang="en">The development of telematic exchange of information in pharmacovigilance has as a consequence the necessary development of the messages used to transmit the information. The first of these messages is the one used to transmit information on individual case reports. Common formats exist on paper, but these have not been applied to electronic transmission. A structured message for the transmission of single case information has been developed within the ENS European research programme, by three National Pharmacovigilance administrations, and reviewed by the relevant European bodies. It has been submitted to the Western European Edifact Board MD9 for admission as an EDIFACT message, so that it will be possible to exchange information concerning these single cases, using standard EDI methodology.</abstract>
<subject lang="en"><genre>keywords</genre>
<topic>Pharmacovigilance</topic>
<topic>telematics</topic>
<topic>adverse reactions</topic>
<topic>reports</topic>
<topic>electronic data interchange</topic>
<topic>regulations</topic>
<topic>Europe</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Pharmacoepidemiology and Drug Safety</title>
</titleInfo>
<titleInfo type="abbreviated"><title>Pharmacoepidem. Drug Safe.</title>
</titleInfo>
<genre type="journal">journal</genre>
<subject><genre>article-category</genre>
<topic>Special Report</topic>
</subject>
<identifier type="ISSN">1053-8569</identifier>
<identifier type="eISSN">1099-1557</identifier>
<identifier type="DOI">10.1002/(ISSN)1099-1557</identifier>
<identifier type="PublisherID">PDS</identifier>
<part><date>1994</date>
<detail type="volume"><caption>vol.</caption>
<number>3</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>3</number>
</detail>
<extent unit="pages"><start>157</start>
<end>162</end>
<total>6</total>
</extent>
</part>
</relatedItem>
<identifier type="istex">758673941CD84142C36F044BDAB0D41FAAA4A937</identifier>
<identifier type="DOI">10.1002/pds.2630030306</identifier>
<identifier type="ArticleID">PDS2630030306</identifier>
<accessCondition type="use and reproduction" contentType="copyright">Copyright © 1994 John Wiley & Sons, Ltd.</accessCondition>
<recordInfo><recordContentSource>WILEY</recordContentSource>
<recordOrigin>John Wiley & Sons, Ltd.</recordOrigin>
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