Electronic submission capability to FDA for academic investigators – the process, challenges, and opportunities affecting the translational research enterprise
Identifieur interne : 000181 ( Ncbi/Merge ); précédent : 000180; suivant : 000182Electronic submission capability to FDA for academic investigators – the process, challenges, and opportunities affecting the translational research enterprise
Auteurs : E Mitchell Seymour [États-Unis] ; Antoinette Azevedo [États-Unis] ; Jeanne K. Wright [États-Unis] ; Bill R. Reisdorph [États-Unis] ; Mona Moore [États-Unis] ; Kevin J. Weatherwax [États-Unis]Source :
- Clinical and translational science [ 1752-8054 ] ; 2013.
Url:
DOI: 10.1111/cts.12123
PubMed: 24528901
PubMed Central: 4042394
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PMC:4042394Le document en format XML
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<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
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<title-group><article-title>Electronic submission capability to FDA for academic investigators – the process, challenges, and opportunities affecting the translational research enterprise</article-title>
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<contrib-group><contrib contrib-type="author"><name><surname>Seymour</surname>
<given-names>E Mitchell</given-names>
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<contrib contrib-type="author"><name><surname>Azevedo</surname>
<given-names>Antoinette</given-names>
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<contrib contrib-type="author"><name><surname>Reisdorph</surname>
<given-names>Bill R.</given-names>
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<contrib contrib-type="author"><name><surname>Moore</surname>
<given-names>Mona</given-names>
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<degrees>M.S</degrees>
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<contrib contrib-type="author"><name><surname>Weatherwax</surname>
<given-names>Kevin J.</given-names>
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<degrees>B.S</degrees>
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<aff id="A1"><label>1</label>
Michigan Institute for Clinical and Health Research IND/IDE Assistance Program, 2800 Plymouth Road, NCRC B400, Ann Arbor, MI 48109</aff>
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<ext-link ext-link-type="uri" xlink:href="http://e-SubmissionSolutions.com">e-SubmissionSolutions.com</ext-link>
and Sage Submissions, 3519 Eugene Place, San Diego, CA 92116-1930</aff>
<author-notes><corresp id="cor1"><bold>Corresponding Author:</bold>
E Mitchell Seymour, PhD RAC; 2800 Plymouth Road, NCRC B400, Ann Arbor, MI 48109; <email>seymoure@med.umich.edu</email>
; 734-998-6585</corresp>
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<pub-date pub-type="nihms-submitted"><day>31</day>
<month>3</month>
<year>2014</year>
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<month>11</month>
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<month>2</month>
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<name sortKey="Weatherwax, Kevin J" sort="Weatherwax, Kevin J" uniqKey="Weatherwax K" first="Kevin J." last="Weatherwax">Kevin J. Weatherwax</name>
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