{"ID":78170,"post_author":"9208550","post_date":"2018-12-17 15:51:56","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"Introduction to Health and Biomedical Informatics","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2018-12-17 15:51:56","post_modified_gmt":"2018-12-17 20:51:56","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=78170","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"1869ED85-9396-4C34-8394-1332C7F45029","title":"Introduction to Health and Biomedical Informatics","subtitle":"Volume 1","cover_theme":"nico_6","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_6&subtitle=Volume+1&editor=John+Jones&title=Introduction+to+Health+and+Biomedical+Informatics&title_image=https%3A%2F%2Fupload.wikimedia.org%2Fwikipedia%2Fcommons%2Fthumb%2F5%2F53%2FMaquet_Flow-I_anesthesia_machine.jpg%2F440px-Maquet_Flow-I_anesthesia_machine.jpg&publisher=Laboratory+Informatics+Institute","editor":"John Jones","publisher":"Laboratory Informatics Institute","author_id":"2","image_url":"","items":{"97a1396e3ca27b24f4efc757fdc135f3_type":"article","97a1396e3ca27b24f4efc757fdc135f3_title":"xDT","97a1396e3ca27b24f4efc757fdc135f3_url":"https:\/\/www.limswiki.org\/index.php\/XDT","97a1396e3ca27b24f4efc757fdc135f3_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\txDT\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t \n\nxDT (aka KVDT) is a family of data exchange formats that are used by physicians and health care administration in Germany. They were created by initiative of the Kassen\u00e4rztliche Bundesvereinigung (National Association of Statutory Health Insurance Physicians - NASHIP).\n\nFormats \nAs of October 2013 the following formats have been implemented:\n\nADT (Abrechnungsdatentransfer): A format for transferring billing data\nBDT (Behandlungsdatentransfer): A format for exchange of complete electronic health records among electronic health record software systems\nGDT (Ger\u00e4tedatentransfer): A format to transfer data among medical devices and software systems\nLDT (Labordatentr\u00e4ger): A format to transfer orders of laboratory tests and their results.\nExternal links \nNASHIP interface description (in German)\nxDT field directory in gms Wiki[permanent dead link ] \n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/XDT\">https:\/\/www.limswiki.org\/index.php\/XDT<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:59.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 235 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","97a1396e3ca27b24f4efc757fdc135f3_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-XDT skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">xDT<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><p><span><\/span>\n<\/p>\n<div class=\"mw-parser-output\"><p><b>xDT<\/b> (aka KVDT) is a family of <a href=\"https:\/\/en.wikipedia.org\/wiki\/Data_exchange\" title=\"Data exchange\" rel=\"external_link\" target=\"_blank\">data exchange formats<\/a> that are used by <a href=\"https:\/\/en.wikipedia.org\/wiki\/Physician\" title=\"Physician\" rel=\"external_link\" target=\"_blank\">physicians<\/a> and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_care_administration\" class=\"mw-redirect\" title=\"Health care administration\" rel=\"external_link\" target=\"_blank\">health care administration<\/a> in <a href=\"https:\/\/en.wikipedia.org\/wiki\/Germany\" title=\"Germany\" rel=\"external_link\" target=\"_blank\">Germany<\/a>. They were created by initiative of the <i>Kassen\u00e4rztliche Bundesvereinigung<\/i> (<a href=\"https:\/\/en.wikipedia.org\/wiki\/National_Association_of_Statutory_Health_Insurance_Physicians\" title=\"National Association of Statutory Health Insurance Physicians\" rel=\"external_link\" target=\"_blank\">National Association of Statutory Health Insurance Physicians<\/a> - NASHIP).\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Formats\">Formats<\/span><\/h2>\n<p>As of October 2013 the following formats have been implemented:\n<\/p>\n<ul><li><b>ADT<\/b> (<i>Abrechnungsdatentransfer<\/i>): A format for transferring billing data<\/li>\n<li><b>BDT<\/b> (<i>Behandlungsdatentransfer<\/i>): A format for exchange of complete <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electronic_health_record\" title=\"Electronic health record\" rel=\"external_link\" target=\"_blank\">electronic health records<\/a> among electronic health record software systems<\/li>\n<li><b>GDT<\/b> (<i>Ger\u00e4tedatentransfer<\/i>): A format to transfer data among medical devices and software systems<\/li>\n<li><b>LDT<\/b> (<i>Labordatentr\u00e4ger<\/i>): A format to transfer orders of laboratory tests and their results.<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"ftp:\/\/ftp.kbv.de\/ita-update\/Abrechnung\/KBV_ITA_VGEX_Datensatzbeschreibung_KVDT.pdf\" target=\"_blank\">NASHIP interface description (in German)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.qms-de.org\/images\/5\/50\/XDT_Feldverzeichnis.pdf\" target=\"_blank\">xDT field directory in gms Wiki<\/a><sup class=\"noprint Inline-Template\"><span style=\"white-space: nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Link_rot\" title=\"Wikipedia:Link rot\" rel=\"external_link\" target=\"_blank\"><span title=\" Dead link since July 2016\">permanent dead link<\/span><\/a><\/i>]<\/span><\/sup><\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1254\nCached time: 20181125224442\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.040 seconds\nReal time usage: 0.066 seconds\nPreprocessor visited node count: 128\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 1848\/2097152 bytes\nTemplate argument size: 543\/2097152 bytes\nHighest expansion depth: 11\/40\nExpensive parser function count: 1\/500\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.016\/10.000 seconds\nLua memory usage: 821 KB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 55.928 1 Template:Dead_link\n100.00% 55.928 1 -total\n<\/p>\n<pre>71.06% 39.744 1 Template:Fix\n64.42% 36.029 2 Template:Category_handler\n 6.50% 3.635 1 Template:Fix\/category\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:40856034-1!canonical and timestamp 20181125224442 and revision id 827549781\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/XDT\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205342\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.012 seconds\nReal time usage: 0.141 seconds\nPreprocessor visited node count: 15\/1000000\nPreprocessor generated node count: 66\/1000000\nPost\u2010expand include size: 39\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 4\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 137.322 1 - -total\n 96.97% 133.165 1 - wikipedia:XDT\n 1.98% 2.722 1 - Template:Lowercase_title\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9178-0!*!*!*!*!*!* and timestamp 20181217205342 and revision id 27137\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/XDT\">https:\/\/www.limswiki.org\/index.php\/XDT<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","97a1396e3ca27b24f4efc757fdc135f3_images":[],"97a1396e3ca27b24f4efc757fdc135f3_timestamp":1545080022,"ff0784fe9683d3e3f0ab5351a126cd05_type":"article","ff0784fe9683d3e3f0ab5351a126cd05_title":"Virtual Medical Record","ff0784fe9683d3e3f0ab5351a126cd05_url":"https:\/\/www.limswiki.org\/index.php\/Virtual_Medical_Record","ff0784fe9683d3e3f0ab5351a126cd05_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tVirtual Medical Record\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThe examples and perspective in this article may not represent a worldwide view of the subject. You may improve this article, discuss the issue on the talk page, or create a new article, as appropriate. (March 2015) (Learn how and when to remove this template message)\nThe Virtual Medical Record (vMR) is a simplified, standardised electronic health record data model designed to support interfacing to clinical decision support (CDS) systems. vMR is compatible with Service-oriented Architecture (SOA) of CDS.\nThe project is sponsored by HL7.[1]\n\nReferences \n\n\n^ HL7 Project Wiki \n\n\nThis health-related article is a stub. You can help Wikipedia by expanding it.vte\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Virtual_Medical_Record\">https:\/\/www.limswiki.org\/index.php\/Virtual_Medical_Record<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:58.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 197 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","ff0784fe9683d3e3f0ab5351a126cd05_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Virtual_Medical_Record skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Virtual Medical Record<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n<p>The <b>Virtual Medical Record<\/b> (vMR) is a simplified, standardised <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electronic_health_record\" title=\"Electronic health record\" rel=\"external_link\" target=\"_blank\">electronic health record<\/a> data model designed to support interfacing to <a href=\"https:\/\/en.wikipedia.org\/wiki\/Clinical_decision_support\" class=\"mw-redirect\" title=\"Clinical decision support\" rel=\"external_link\" target=\"_blank\">clinical decision support<\/a> (CDS) systems. vMR is compatible with Service-oriented Architecture (SOA) of CDS.\n<\/p><p>The project is sponsored by <a href=\"https:\/\/en.wikipedia.org\/wiki\/HL7\" class=\"mw-redirect\" title=\"HL7\" rel=\"external_link\" target=\"_blank\">HL7<\/a>.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Virtual_Medical_Record_(vMR)\" target=\"_blank\">HL7 Project Wiki<\/a><\/span>\n<\/li>\n<\/ol><\/div><\/div>\n\n<p><!-- \nNewPP limit report\nParsed by mw1272\nCached time: 20181201021529\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.064 seconds\nReal time usage: 0.105 seconds\nPreprocessor visited node count: 185\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 6969\/2097152 bytes\nTemplate argument size: 96\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 1\/500\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 419\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.028\/10.000 seconds\nLua memory usage: 1.16 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 89.685 1 -total\n<\/p>\n<pre>64.96% 58.262 1 Template:Globalize\n45.48% 40.787 1 Template:Ambox\n19.57% 17.549 1 Template:Health-stub\n16.65% 14.928 1 Template:Asbox\n13.12% 11.771 1 Template:Reflist\n 2.82% 2.526 1 Template:Main_other\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:32942689-1!canonical and timestamp 20181201021529 and revision id 832120890\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/Virtual_Medical_Record\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205341\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.009 seconds\nReal time usage: 0.142 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 136.030 1 - wikipedia:Virtual_Medical_Record\n100.00% 136.030 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9177-0!*!*!*!*!*!* and timestamp 20181217205341 and revision id 27136\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Virtual_Medical_Record\">https:\/\/www.limswiki.org\/index.php\/Virtual_Medical_Record<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","ff0784fe9683d3e3f0ab5351a126cd05_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/6\/66\/Esculaap4.svg\/40px-Esculaap4.svg.png"],"ff0784fe9683d3e3f0ab5351a126cd05_timestamp":1545080021,"1c3112f1477068a6d34ccd1dd192c1ff_type":"article","1c3112f1477068a6d34ccd1dd192c1ff_title":"Structured Product Labeling","1c3112f1477068a6d34ccd1dd192c1ff_url":"https:\/\/www.limswiki.org\/index.php\/Structured_Product_Labeling","1c3112f1477068a6d34ccd1dd192c1ff_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tStructured Product Labeling\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThis article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. (August 2009) (Learn how and when to remove this template message)\nStructured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format.[1] The \"drug label\" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug.[2][3] As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.[3]\nSPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).\n\nContents \n\n1 Background \n2 SPL Working Group \n\n2.1 Composition of the SPL Working Group \n2.2 Current Objectives of the SPL Working Group \n\n\n3 SPL specification outline \n4 Format \n5 Examples \n6 Use of LOINC, UNII, SNOMED-CT, UCUM, and other controlled terminologies \n7 Sections \n\n7.1 title \n\n7.1.1 title of component \n\n\n\n\n8 Misc \n9 SPL Solutions \n10 References \n11 External links \n\n\nBackground \nSince October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation and Research (CDER) must be in SPL format. In addition, annual report submissions must contain content of labeling in SPL format.\nIn January 2006, the FDA unveiled a major change to the format of prescription drug information, commonly referred to as the Physician Labeling Rule (PLR). The new format requires that the content of labeling be organized in a specific manner. Other changes include the addition of a Highlights section that contains key benefit and risk information, a table of contents, the date of initial product approval, and a toll-free number and URL for reporting suspected adverse events.\nStarting June 1, 2009, the FDA will require all OTC companies and Veterinary Medicines (Vet Med) manufacturers to submit their product labeling in compliance with the SPL standards. Additionally, all companies that produce Pharmaceutical (Rx), Over-the-Counter (OTC), Biologics products, Veterinary medicines, and distributors must provide FDA with all registration listing and drug listings in the SPL electronic format.\nFDA-approved SPLs can be viewed and downloaded from \"DailyMed\" on the National Library of Medicine web site. DailyMed provides free access to consumers and health information providers to comprehensive, up-to-date labeling as found in medication package inserts.\n\nSPL Working Group \nThe SPL Standard was initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee. HL7 is an independent and international provider of healthcare standards. PhRMA HL7 Task Group formed the SPL Working Group in January 2004 to further the work of the initial development team.\n\nComposition of the SPL Working Group \nThe group has grown significantly since its inception in 2004. Participants come from:\nIndustry sponsors of human and veterinary (pharmaceuticals, generic pharmaceuticals, biologics, devices, over-the-counter) products submitted to the FDA.\nFDA representatives\nVendors\nHealth Level Seven International<\/dd>\nThe SPL Working Group has a Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle, and Over-the-Counter (OTC) Products. These teams meet regularly, and meeting information and minutes of past meetings are available on the SPL Working Group All Sub-Groups wiki page.[4]\n\nCurrent Objectives of the SPL Working Group \nRaise industry awareness concerning SPL (on-going)\nSponsor industry webcasts and meetings, as appropriate\nProvide forum for discussion of issues, best practices, and FDA documentation of SPL\nReview changes to HL7 SPL model\nReview changes to XSL Stylesheet\nProduce revisions to Implementation Guide in line with schema releases\nDetermine future direction of SPL Standard\nSPL specification outline \nThis section is empty. You can help by adding to it. (January 2014)\nFormat \nThis section is empty. You can help by adding to it. (July 2013)\nExamples \nThis section is empty. You can help by adding to it. (July 2013)\n Use of LOINC, UNII, SNOMED-CT, UCUM, and other controlled terminologies \nThis section is empty. You can help by adding to it. (July 2013)\nSections \nTBD. General outline of the document tree\n\ntitle \nClass\n\ntemplateId\ncode\ntext\nOther details\n\ntitle of component \nEtc\n\nMisc \nThis section is empty. You can help by adding to it. (January 2014)\nSPL Solutions \nVarious approaches exist for creating and managing content and data in SPL format. Solutions fall under three basic categories.\n\nInstalled Software\nSoftware-as-a-Service (SaaS)\nOutsourcing\nReferences \n\n\n^ Office of the Commissioner (May 2009). Guidance for Industry: Providing Regulatory Submissions in Electronic Format \u2013 Drug Establishment Registration and Drug Listing (PDF) (Report). Food and Drug Administration. Retrieved 2015-07-18 . \n\n^ Kass-Hout, Taha A. (18 August 2014). \"Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling\". FDA Voice (blog). Retrieved 2015-07-19 . \n\n^ a b \"HL7 Standards Product Brief - HL7 Version 3 Standard: Structured Product Labeling, Release 4\". Health Level Seven International. Retrieved 2015-07-19 . \n\n^ (page history contains authors). \"All Sub-Groups\". SPL-work-group (wiki). Wikispaces. Retrieved 2015-07-18 . \n\n\nExternal links \nFDA SPL Resources \nGuidance for Industry: Providing Regulatory Submissions in Electronic Format \u2013 Drug Establishment Registration and Drug Listing (Final)\nSPL Working Group\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Structured_Product_Labeling\">https:\/\/www.limswiki.org\/index.php\/Structured_Product_Labeling<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:57.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 179 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","1c3112f1477068a6d34ccd1dd192c1ff_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Structured_Product_Labeling skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Structured Product Labeling<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n<p><b>Structured Product Labeling<\/b> (<b>SPL<\/b>) is a <a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_Level_Seven_International\" title=\"Health Level Seven International\" rel=\"external_link\" target=\"_blank\">Health Level Seven International<\/a> (HL7) standard which defines the content of human <a href=\"https:\/\/en.wikipedia.org\/wiki\/Prescription_drug\" title=\"Prescription drug\" rel=\"external_link\" target=\"_blank\">prescription drug<\/a> <a href=\"https:\/\/en.wikipedia.org\/wiki\/Package_insert\" class=\"mw-redirect\" title=\"Package insert\" rel=\"external_link\" target=\"_blank\">labeling<\/a> in an <a href=\"https:\/\/en.wikipedia.org\/wiki\/XML\" title=\"XML\" rel=\"external_link\" target=\"_blank\">XML<\/a> format.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup> The \"drug label\" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Package_insert\" class=\"mw-redirect\" title=\"Package insert\" rel=\"external_link\" target=\"_blank\">package insert<\/a> which contains a great deal of detailed information about the drug.<sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:0_3-0\" class=\"reference\"><a href=\"#cite_note-:0-3\" rel=\"external_link\">[3]<\/a><\/sup> As of Release 4 of the SPL standard, 22,000 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">FDA<\/a> informational product inserts have been encoded according to the standard.<sup id=\"rdp-ebb-cite_ref-:0_3-1\" class=\"reference\"><a href=\"#cite_note-:0-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).\n<\/p>\n\n<h2><span class=\"mw-headline\" id=\"Background\">Background<\/span><\/h2>\n<p>Since October 31, 2005, labeling submissions to the FDA's <a href=\"https:\/\/en.wikipedia.org\/wiki\/Center_for_Drug_Evaluation_and_Research\" title=\"Center for Drug Evaluation and Research\" rel=\"external_link\" target=\"_blank\">Center for Drug Evaluation and Research<\/a> (CDER) must be in SPL format. In addition, annual report submissions must contain content of labeling in SPL format.\n<\/p><p>In January 2006, the FDA unveiled a major change to the format of prescription drug information, commonly referred to as the Physician Labeling Rule (PLR). The new format requires that the content of labeling be organized in a specific manner. Other changes include the addition of a Highlights section that contains key benefit and risk information, a table of contents, the date of initial product approval, and a toll-free number and URL for reporting suspected adverse events.\n<\/p><p>Starting June 1, 2009, the FDA will require all OTC companies and Veterinary Medicines (Vet Med) manufacturers to submit their product labeling in compliance with the SPL standards. Additionally, all companies that produce Pharmaceutical (Rx), Over-the-Counter (OTC), Biologics products, Veterinary medicines, and distributors must provide FDA with all registration listing and drug listings in the SPL electronic format.\n<\/p><p>FDA-approved SPLs can be viewed and downloaded from \"DailyMed\" on the <a href=\"https:\/\/en.wikipedia.org\/wiki\/National_Library_of_Medicine\" class=\"mw-redirect\" title=\"National Library of Medicine\" rel=\"external_link\" target=\"_blank\">National Library of Medicine<\/a> web site. <a href=\"https:\/\/en.wikipedia.org\/wiki\/DailyMed\" title=\"DailyMed\" rel=\"external_link\" target=\"_blank\">DailyMed<\/a> provides free access to consumers and health information providers to comprehensive, up-to-date labeling as found in medication package inserts.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"SPL_Working_Group\">SPL Working Group<\/span><\/h2>\n<p>The SPL Standard was initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_Level_Seven_International\" title=\"Health Level Seven International\" rel=\"external_link\" target=\"_blank\">HL7<\/a> is an independent and international provider of healthcare standards. PhRMA HL7 Task Group formed the SPL Working Group in January 2004 to further the work of the initial development team.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Composition_of_the_SPL_Working_Group\">Composition of the SPL Working Group<\/span><\/h3>\n<dl><dd>The group has grown significantly since its inception in 2004. Participants come from:\n<dl><dd><ul><li>Industry sponsors of human and veterinary (pharmaceuticals, generic pharmaceuticals, biologics, devices, over-the-counter) products submitted to the FDA.<\/li>\n<li>FDA representatives<\/li>\n<li>Vendors<\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_Level_Seven_International\" title=\"Health Level Seven International\" rel=\"external_link\" target=\"_blank\">Health Level Seven International<\/a><\/li><\/ul><\/dd><\/dl><\/dd><\/dl>\n<p>The SPL Working Group has a Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle, and Over-the-Counter (OTC) Products. These teams meet regularly, and meeting information and minutes of past meetings are available on the SPL Working Group All Sub-Groups wiki page.<sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Current_Objectives_of_the_SPL_Working_Group\">Current Objectives of the SPL Working Group<\/span><\/h3>\n<dl><dd><ul><li>Raise industry awareness concerning SPL (on-going)<\/li>\n<li>Sponsor industry webcasts and meetings, as appropriate<\/li>\n<li>Provide forum for discussion of issues, best practices, and FDA documentation of SPL<\/li>\n<li>Review changes to HL7 SPL model<\/li>\n<li>Review changes to XSL Stylesheet<\/li>\n<li>Produce revisions to Implementation Guide in line with schema releases<\/li>\n<li>Determine future direction of SPL Standard<\/li><\/ul><\/dd><\/dl>\n<h2><span class=\"mw-headline\" id=\"SPL_specification_outline\">SPL specification outline<\/span><\/h2>\n\n<h2><span class=\"mw-headline\" id=\"Format\">Format<\/span><\/h2>\n\n<h2><span class=\"mw-headline\" id=\"Examples\">Examples<\/span><\/h2>\n\n<h2><span id=\"rdp-ebb-Use_of_LOINC.2C_UNII.2C_SNOMED-CT.2C_UCUM.2C_and_other_controlled_terminologies\"><\/span><span class=\"mw-headline\" id=\"Use_of_LOINC,_UNII,_SNOMED-CT,_UCUM,_and_other_controlled_terminologies\">Use of LOINC, UNII, SNOMED-CT, UCUM, and other controlled terminologies<\/span><\/h2>\n\n<h2><span class=\"mw-headline\" id=\"Sections\">Sections<\/span><\/h2>\n<p>TBD. General outline of the document tree\n<\/p>\n<h3><span class=\"mw-headline\" id=\"title\">title<\/span><\/h3>\n<p><b>Class<\/b>\n<\/p>\n<ul><li>templateId<\/li>\n<li>code<\/li>\n<li>text<\/li><\/ul>\n<p><i>Other details<\/i>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"title_of_component\">title of component<\/span><\/h4>\n<p><i>Etc<\/i>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Misc\">Misc<\/span><\/h2>\n\n<h2><span class=\"mw-headline\" id=\"SPL_Solutions\">SPL Solutions<\/span><\/h2>\n<p>Various approaches exist for creating and managing content and data in SPL format. Solutions fall under three basic categories.\n<\/p>\n<dl><dd><ul><li>Installed Software<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ddismart.com\/labelai\" target=\"_blank\">Software-as-a-Service (SaaS)<\/a><\/li>\n<li>Outsourcing<\/li><\/ul><\/dd><\/dl>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation report\">Office of the Commissioner (May 2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm072339.pdf\" target=\"_blank\">Guidance for Industry: Providing Regulatory Submissions in Electronic Format \u2013 Drug Establishment Registration and Drug Listing<\/a> <span class=\"cs1-format\">(PDF)<\/span> (Report). <a href=\"https:\/\/en.wikipedia.org\/wiki\/USFDA\" class=\"mw-redirect\" title=\"USFDA\" rel=\"external_link\" target=\"_blank\">Food and Drug Administration<\/a><span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2015-07-18<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=report&rft.btitle=Guidance+for+Industry%3A+Providing+Regulatory+Submissions+in+Electronic+Format+%E2%80%93+Drug+Establishment+Registration+and+Drug+Listing&rft.pub=Food+and+Drug+Administration&rft.date=2009-05&rft.au=Office+of+the+Commissioner&rft_id=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FDrugs%2FGuidanceComplianceRegulatoryInformation%2FGuidances%2Fucm072339.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStructured+Product+Labeling\" class=\"Z3988\"><\/span><\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-2\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/Taha_Kass-Hout\" class=\"mw-redirect\" title=\"Taha Kass-Hout\" rel=\"external_link\" target=\"_blank\">Kass-Hout, Taha A.<\/a> (18 August 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/blogs.fda.gov\/fdavoice\/index.php\/2014\/08\/providing-easy-public-access-to-prescription-drug-over-the-counter-drug-and-biological-product-labeling\/\" target=\"_blank\">\"Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling\"<\/a>. <i>FDA Voice<\/i> (blog)<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2015-07-19<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=FDA+Voice&rft.atitle=Providing+Easy+Public+Access+to+Prescription+Drug%2C+Over-the-Counter+Drug%2C+and+Biological+Product+Labeling&rft.date=2014-08-18&rft.aulast=Kass-Hout&rft.aufirst=Taha+A.&rft_id=http%3A%2F%2Fblogs.fda.gov%2Ffdavoice%2Findex.php%2F2014%2F08%2Fproviding-easy-public-access-to-prescription-drug-over-the-counter-drug-and-biological-product-labeling%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStructured+Product+Labeling\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-:0-3\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-:0_3-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-:0_3-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=96\" target=\"_blank\">\"HL7 Standards Product Brief - HL7 Version 3 Standard: Structured Product Labeling, Release 4\"<\/a>. Health Level Seven International<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2015-07-19<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=HL7+Standards+Product+Brief+-+HL7+Version+3+Standard%3A+Structured+Product+Labeling%2C+Release+4&rft.pub=Health+Level+Seven+International&rft_id=http%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Fproduct_brief.cfm%3Fproduct_id%3D96&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStructured+Product+Labeling\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-4\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-4\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\">(page history contains authors). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/spl-work-group.wikispaces.com\/All+Sub-Groups\" target=\"_blank\">\"All Sub-Groups\"<\/a>. <i>SPL-work-group<\/i> (wiki). Wikispaces<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2015-07-18<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=SPL-work-group&rft.atitle=All+Sub-Groups&rft.au=%28page+history+contains+authors%29&rft_id=http%3A%2F%2Fspl-work-group.wikispaces.com%2FAll%2BSub-Groups&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStructured+Product+Labeling\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/ForIndustry\/DataStandards\/StructuredProductLabeling\/default.htm\" target=\"_blank\">FDA SPL Resources <\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/downloads\/ForIndustry\/DataStandards\/StructuredProductLabeling\/UCM164053.pdf\" target=\"_blank\">Guidance for Industry: Providing Regulatory Submissions in Electronic Format \u2013 Drug Establishment Registration and Drug Listing (Final)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/spl-work-group.wikispaces.com\" target=\"_blank\">SPL Working Group<\/a><\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1271\nCached time: 20181129153951\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.152 seconds\nReal time usage: 0.219 seconds\nPreprocessor visited node count: 611\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 25915\/2097152 bytes\nTemplate argument size: 224\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 5\/500\nUnstrip recursion depth: 1\/20\nUnstrip post\u2010expand size: 11231\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.085\/10.000 seconds\nLua memory usage: 2.34 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 185.982 1 -total\n<\/p>\n<pre>53.14% 98.828 1 Template:Reflist\n36.38% 67.655 1 Template:Cite_report\n32.21% 59.899 1 Template:Refimprove\n30.36% 56.466 6 Template:Ambox\n12.45% 23.157 5 Template:Empty_section\n 7.69% 14.302 3 Template:Cite_web\n 1.70% 3.155 1 Template:Main_other\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:8150231-1!canonical and timestamp 20181129153951 and revision id 870080435\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/Structured_Product_Labeling\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205341\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.009 seconds\nReal time usage: 0.147 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 140.353 1 - wikipedia:Structured_Product_Labeling\n100.00% 140.353 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9176-0!*!*!*!*!*!* and timestamp 20181217205341 and revision id 27135\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Structured_Product_Labeling\">https:\/\/www.limswiki.org\/index.php\/Structured_Product_Labeling<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","1c3112f1477068a6d34ccd1dd192c1ff_images":["https:\/\/upload.wikimedia.org\/wikipedia\/en\/thumb\/9\/99\/Question_book-new.svg\/100px-Question_book-new.svg.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/1\/1c\/Wiki_letter_w_cropped.svg\/40px-Wiki_letter_w_cropped.svg.png"],"1c3112f1477068a6d34ccd1dd192c1ff_timestamp":1545080021,"3c8ac1283e584672412c6086b62a50b5_type":"article","3c8ac1283e584672412c6086b62a50b5_title":"Standard for Exchange of Non-clinical Data","3c8ac1283e584672412c6086b62a50b5_url":"https:\/\/www.limswiki.org\/index.php\/Standard_for_Exchange_of_Non-clinical_Data","3c8ac1283e584672412c6086b62a50b5_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tStandard for Exchange of Non-clinical Data\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t An FDA building.\nThe Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development. Raw data of toxicology animal studies started after December 18, 2016 to support submission of new drugs to the US Food and Drug Administration will be submitted to the agency using SEND.\nHaving a common model to which the industry can conform enables benefits such as the ability for vendors to develop tools, for inter-organizational data exchange that is consistent in format regardless of the parties involved, and so on.\nA SEND package consists of a few parts, but the main focus is on individual endpoint data. Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields).\n\nContents \n\n1 Implementation \n2 History \n3 See also \n4 References \n5 External links \n\n\nImplementation \nThe SEND Implementation Guide (SENDIG) is a document that provides implementers with specifications for implementing SEND, including how to model various nonclinical endpoints, rules to doing so, and examples with sample data. This document is available on the CDISC SEND website.[1]\nSupplementing the guide is the SEND Implementation Wiki[2] is a wiki hosted by PhUSE designed to assist with the implementation process and filling in some of the gaps, most notably containing:\n\nSEND, CT, and Define.xml Fundamentals pages \u2013 providing entry-level descriptions of fundamental concepts in SEND, such as SEND itself, Controlled Terminology (CT), and Define.xml\nGetting SEND-ready \u2013 to help new implementers get started\nFAQ \u2013 providing a large, evolving list of commonly asked questions\nCompanion to the wiki is the SEND Implementation Forum,[3] which allows implementers to ask questions and get responses from SEND experts. New implementers are encouraged to ask questions here.\n\nHistory \nThe work on this standard began in July 2002\u2014subsequently, a U.S. Food and Drug Administration pilot project was initiated in July 2003 through a Cooperative Research and Development Agreement (CRADA). Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of SEND 2.3, but without widespread adoption.\nIn 2006, with renewed FDA interest, the industry met to revive SEND and work on a version that, with FDA backing, would cover regulatory submission as well as operational data transfer needs. By 2007, an FDA pilot was announced, during which time the SEND team worked on the SENDIG (implementation guide).\nSENDIG 3.0 was released to production in July 2011. This was soon followed by the FDA's statement of preference for SEND datasets.\nIn December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration. All studies started after December 15, 2016 supporting IND and BLA submissions will need to be compliant with SEND. The Pharmaceuticals and Medical Devices Agency in Japan will enforce its use in the future, most probably in 2020. The European Medicines Agency also expressed interest and is recommending the use of SEND.\nSENDIG 3.1 was released in June 2016, extending the format with new data domains. \nSENDIG-DART 1.0 was given a provisional release in August 2016. SENDIG-DART is a standard which extends the SENDIG 3.0 standard for use with Development and Reproductive Toxicology Studies.\nConsider the SENDIG and the PhUSE SEND Implementation Wiki pages for additional related information.\n\n<\/p>\nSee also \nCDISC\nSDTM\nPhUSE\nReferences \n\n\n^ CDISC SEND \n\n^ SEND Implementation Wiki \n\n^ SEND Implementation Forum \n\n\nExternal links \nCDISC SEND - for the SEND Implementation Guide, Controlled Terminology, and more\nFDA Data Standards - for the FDA's list of supported standards and associated resources\nSEND Implementation Wiki - for frequently asked questions and implementation assistance\nSEND Implementation Forum - for asking questions about implementing SEND\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Standard_for_Exchange_of_Non-clinical_Data\">https:\/\/www.limswiki.org\/index.php\/Standard_for_Exchange_of_Non-clinical_Data<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom 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\r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:56.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 322 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","3c8ac1283e584672412c6086b62a50b5_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Standard_for_Exchange_of_Non-clinical_Data skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Standard for Exchange of Non-clinical Data<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:222px;\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:FDA_Bldg_51_-_Main_Entrance_(5161374834).jpg\" class=\"image\" rel=\"external_link\" target=\"_blank\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/3d\/FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg\/220px-FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg\" width=\"220\" height=\"147\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:FDA_Bldg_51_-_Main_Entrance_(5161374834).jpg\" class=\"internal\" title=\"Enlarge\" rel=\"external_link\" target=\"_blank\"><\/a><\/div>An FDA building.<\/div><\/div><\/div>\n<p>The <b>Standard for Exchange of Nonclinical Data<\/b> (<b>SEND<\/b>) is an implementation of the <a href=\"https:\/\/en.wikipedia.org\/wiki\/CDISC\" class=\"mw-redirect\" title=\"CDISC\" rel=\"external_link\" target=\"_blank\">CDISC<\/a> <a href=\"https:\/\/en.wikipedia.org\/wiki\/SDTM\" title=\"SDTM\" rel=\"external_link\" target=\"_blank\">Standard Data Tabulation Model (SDTM)<\/a> for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development. Raw data of toxicology animal studies started after December 18, 2016 to support submission of new drugs to the US <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">Food and Drug Administration<\/a> will be submitted to the agency using SEND.\n<\/p><p>Having a common model to which the industry can conform enables benefits such as the ability for vendors to develop tools, for inter-organizational data exchange that is consistent in format regardless of the parties involved, and so on.\n<\/p><p>A SEND package consists of a few parts, but the main focus is on individual endpoint data. Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields).\n<\/p>\n\n<h2><span class=\"mw-headline\" id=\"Implementation\">Implementation<\/span><\/h2>\n<p>The SEND Implementation Guide (SENDIG) is a document that provides implementers with specifications for implementing SEND, including how to model various nonclinical endpoints, rules to doing so, and examples with sample data. This document is available on the CDISC SEND website.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup>\n<\/p><p>Supplementing the guide is the SEND Implementation Wiki<sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup> is a wiki hosted by <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phuse.eu\" target=\"_blank\">PhUSE<\/a> designed to assist with the implementation process and filling in some of the gaps, most notably containing:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki_-_SEND_Fundamentals\" target=\"_blank\">SEND<\/a>, <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki_-_CT_Fundamentals\" target=\"_blank\">CT<\/a>, and <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki_-_Define_Fundamentals\" target=\"_blank\">Define.xml<\/a> Fundamentals pages \u2013 providing entry-level descriptions of fundamental concepts in SEND, such as SEND itself, Controlled Terminology (CT), and Define.xml<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki_-_Getting_SEND-ready\" target=\"_blank\">Getting SEND-ready<\/a> \u2013 to help new implementers get started<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki_-_FAQ\" target=\"_blank\">FAQ<\/a> \u2013 providing a large, evolving list of commonly asked questions<\/li><\/ul>\n<p>Companion to the wiki is the SEND Implementation Forum,<sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\" rel=\"external_link\">[3]<\/a><\/sup> which allows implementers to ask questions and get responses from SEND experts. New implementers are encouraged to ask questions here.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<p>The work on this standard began in July 2002\u2014subsequently, a <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Food_and_Drug_Administration\" class=\"mw-redirect\" title=\"U.S. Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">U.S. Food and Drug Administration<\/a> pilot project was initiated in July 2003 through a <a href=\"https:\/\/en.wikipedia.org\/wiki\/Cooperative_Research_and_Development_Agreement\" class=\"mw-redirect\" title=\"Cooperative Research and Development Agreement\" rel=\"external_link\" target=\"_blank\">Cooperative Research and Development Agreement<\/a> (CRADA). Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of SEND 2.3, but without widespread adoption.\n<\/p><p>In 2006, with renewed FDA interest, the industry met to revive SEND and work on a version that, with FDA backing, would cover regulatory submission as well as operational data transfer needs. By 2007, an FDA pilot was announced, during which time the SEND team worked on the SENDIG (implementation guide).\n<\/p><p>SENDIG 3.0 was released to production in July 2011. This was soon followed by the FDA's statement of preference for SEND datasets.\n<\/p><p>In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of <a href=\"https:\/\/en.wikipedia.org\/wiki\/Investigational_New_Drug\" title=\"Investigational New Drug\" rel=\"external_link\" target=\"_blank\">Investigational New Drug<\/a> (IND) and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Biologic_License_Application\" class=\"mw-redirect\" title=\"Biologic License Application\" rel=\"external_link\" target=\"_blank\">Biologic License Application<\/a> (BLA) submission to the US <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">Food and Drug Administration<\/a>. All studies started after December 15, 2016 supporting IND and BLA submissions will need to be compliant with SEND. The Pharmaceuticals and Medical Devices Agency in Japan will enforce its use in the future, most probably in 2020. The <a href=\"https:\/\/en.wikipedia.org\/wiki\/European_Medicines_Agency\" title=\"European Medicines Agency\" rel=\"external_link\" target=\"_blank\">European Medicines Agency<\/a> also expressed interest and is recommending the use of SEND.\n<\/p><p>SENDIG 3.1 was released in June 2016, extending the format with new data domains. \n<p>SENDIG-DART 1.0 was given a provisional release in August 2016. SENDIG-DART is a standard which extends the SENDIG 3.0 standard for use with Development and Reproductive Toxicology Studies.\nConsider the SENDIG and the SEND Implementation Wiki pages for additional related information.\n<\/p>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/CDISC\" class=\"mw-redirect\" title=\"CDISC\" rel=\"external_link\" target=\"_blank\">CDISC<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/SDTM\" title=\"SDTM\" rel=\"external_link\" target=\"_blank\">SDTM<\/a><\/li>\n<li><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdisc.org\/send\" target=\"_blank\">CDISC SEND<\/a><\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-2\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki\" target=\"_blank\">SEND Implementation Wiki<\/a><\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-3\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Forum\" target=\"_blank\">SEND Implementation Forum<\/a><\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdisc.org\/send\" target=\"_blank\">CDISC SEND<\/a> - for the SEND Implementation Guide, Controlled Terminology, and more<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/ForIndustry\/DataStandards\/StudyDataStandards\/ucm155320.htm\" target=\"_blank\">FDA Data Standards<\/a> - for the FDA's list of supported standards and associated resources<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Wiki\" target=\"_blank\">SEND Implementation Wiki<\/a> - for frequently asked questions and implementation assistance<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.phusewiki.org\/wiki\/index.php?title=SEND_Implementation_Forum\" target=\"_blank\">SEND Implementation Forum<\/a> - for asking questions about implementing SEND<\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1270\nCached time: 20181128064752\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.036 seconds\nReal time usage: 0.047 seconds\nPreprocessor visited node count: 124\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 410\/2097152 bytes\nTemplate argument size: 106\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/500\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 1108\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.003\/10.000 seconds\nLua memory usage: 521 KB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 21.797 1 Template:Reflist\n100.00% 21.797 1 -total\n<\/p>\n<pre>11.41% 2.486 1 Template:Main_other\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:18417601-1!canonical and timestamp 20181128064752 and revision id 760307396\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/Standard_for_Exchange_of_Non-clinical_Data\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205340\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.009 seconds\nReal time usage: 0.144 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 138.733 1 - wikipedia:Standard_for_Exchange_of_Non-clinical_Data\n100.00% 138.733 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9175-0!*!*!*!*!*!* and timestamp 20181217205340 and revision id 27134\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Standard_for_Exchange_of_Non-clinical_Data\">https:\/\/www.limswiki.org\/index.php\/Standard_for_Exchange_of_Non-clinical_Data<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","3c8ac1283e584672412c6086b62a50b5_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/3d\/FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg\/440px-FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg"],"3c8ac1283e584672412c6086b62a50b5_timestamp":1545080020,"a75a2a58db1151695c9582ab631ad58a_type":"article","a75a2a58db1151695c9582ab631ad58a_title":"SDTM","a75a2a58db1151695c9582ab631ad58a_url":"https:\/\/www.limswiki.org\/index.php\/SDTM","a75a2a58db1151695c9582ab631ad58a_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tSDTM\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThis article includes a list of references, related reading or external links, but its sources remain unclear because it lacks inline citations. Please help to improve this article by introducing more precise citations. (October 2009) (Learn how and when to remove this template message)This article relies too much on references to primary sources. Please improve this by adding secondary or tertiary sources. (October 2009) (Learn how and when to remove this template message)\nSDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM.\nOn July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.\n\nContents \n\n1 Background \n2 Datasets and domains \n3 Special-purpose domains \n4 The general domain classes \n5 The CDISC standard domain models (SDTMIG 3.2) \n6 Limitations and Criticism of standards \n7 References \n8 See also \n9 External links \n\n\nBackground \nSDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset or table. Each variable can be classified according to its Role. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into four major roles:\n\nIdentifier variables, which identify the study, subject of the observation, the domain, and the sequence number of the record\nTopic variables, which specify the focus of the observation (such as the name of a lab test)\nTiming variables, which describe the timing of the observation (such as start date and end date)\nQualifier variables, which include additional illustrative text, or numeric values that describe the results or additional traits of the observation (such as units or descriptive adjectives).\nA fifth type of variable role, Rule, can express an algorithm or executable method\nto define start, end, or looping conditions in the Trial Design model.\nThe set of Qualifier variables can be further categorized into five sub-classes:\n\nGrouping Qualifiers are used to group together a collection of observations within the same domain. Examples include --CAT and --SCAT.\nResult Qualifiers describe the specific results associated with the topic variable for a finding. It is the answer to the question raised by the topic variable. Examples include --ORRES, --STRESC, and --STRESN. Many of the values in the DM domain are also classified as Result Qualifiers.\nSynonym Qualifiers specify an alternative name for a particular variable in an observation. Examples include --MODIFY and --DECOD, which are equivalent terms for a --TRT or --TERM topic variable, --TEST and --LOINC which are equivalent terms for a --TESTCD.\nRecord Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Examples include --REASND, AESLIFE, and all other SAE (serious adverse event) flag variables in the AE domain; and --BLFL, --POS and --LOC, --SPEC, --LOT, --NAM.\nVariable Qualifiers are used to further modify or describe a specific variable within an observation and is only meaningful in the context of the variable they qualify. Examples include --ORRESU, --ORNRHI, and --ORNRLO, all of which are variable qualifiers of --ORRES, and --DOSU and --DOSFRM, all of which are variable qualifiers of --DOSE.\nFor example, in the observation, 'Subject 101 had mild nausea starting on Study Day 6,' the Topic variable value is the term for the adverse event, 'NAUSEA'. The Identifier variable is the subject identifier, '101'. The Timing variable is the study day of the start of the event, which captures the information, 'starting on Study Day 6', while an example of a Record Qualifier is the severity, the value for which is 'MILD'.\nAdditional Timing and Qualifier variables could be included to provide the necessary detail to adequately describe an observation.\u2022\tThe SDTM addition to PROC CDISC does not convert existing SDS 2.x content to SDTM 3.x representations.\n\nDatasets and domains \nObservations are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically-related observations with a topic-specific commonality about the subjects in the trial. The logic of the relationship may relate to the scientific matter of the data, or to its role in the trial.\nTypically, each domain is represented by a dataset, but it is possible to have information relevant to the same topicality spread among multiple datasets. Each dataset is distinguished by a unique, two-character DOMAIN code that should be used consistently throughout the submission. This DOMAIN code is used in the dataset name, the value of the DOMAIN variable within that dataset, and as a prefix for most variable names in the dataset.\nThe dataset structure for observations is a flat file representing a table with one or more rows and columns. Normally, one dataset is submitted for each domain. Each row of the dataset represents a single observation and each column represents one of the variables. Each dataset or table is accompanied by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document named 'Define' that is submitted along with the data to regulatory authorities. \nSubmission Metadata Model uses seven distinct metadata attributes to be defined for each dataset variable in the metadata definition document:\n\nThe Variable Name (limited to 8-characters for compatibility with the SAS System V5 Transport format)\nA descriptive Variable Label, using up to 40 characters, which should be unique for each variable in the dataset\nThe data Type (e.g., whether the variable value is a character or numeric)\nThe set of controlled terminology for the value or the presentation format of the variable(Controlled Terms or Format)\nThe Origin or source of each variable\nThe Role of the variable, which determines how the variable is used in the dataset. Roles are used to represent the categories of variables as Identifier, Topic, Timing, or the five types of Qualifiers. Since these roles are predefined for all domains that follow the general classes, they do not need to be specified by sponsors in their Define data definition document. Actual submission metadata may use additional role designations, and more than one role may be assigned per variable to meet different needs.\nComments or other relevant information about the variable or its data.\nData stored in dataset variables include both raw (as originally collected) and derived values (e.g., converted into standard units, or computed on the basis of multiple values, such as an average). In SDTM only the name, label, and type are listed with a set of CDISC guidelines that provide a general description for each variable used by a general observation class. \nComments are included as necessary according to the needs of individual studies.\nThe presence of an asterisk (*) in the 'Controlled Terms or Format' column indicates that a discrete set of values (controlled terminology) is expected to be made available for this variable. This set of values may be sponsor-defined in cases where standard vocabularies have not yet been defined (represented by a single *) or from an external published source such as MedDRA (represented by **).\n\n\u2191\n\n<\/p>\nSpecial-purpose domains \nThe CDISC Version 3.x Submission Data Domain Models include special-purpose domains with a specific\nstructure and cannot be extended with any additional qualifier or timing variables other than those specified. \n\nDemographics includes a set of standard variables that describe each subject in a clinical study\nComments describes a fixed structure for recording free-text comments on a subject, or comments related to records or groups of records in other domains.\nAdditional fixed structure, non-extensible special-purpose domains are discussed in the Trial Design model.\n\nThe general domain classes \nMost observations collected during the study (other than those represented in special purpose domains) should be divided among three general observation classes: Interventions, Events, or Findings:\n\nThe Interventions class captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., \u201cexposure\u201d), coincident with the study assessment period (e.g., \u201cconcomitant medications\u201d), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine)\nThe Events class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., 'adverse events' or 'disposition') or prior to the trial (e.g., 'medical history').\nThe Findings class captures the observations resulting from planned evaluations to address specific questions such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires.\nIn most cases, the identification of the general class appropriate to a specific collection of data by topicality is straightforward. Often the Findings general class is the best choice for general observational data collected as measurements or responses to questions. In cases when the topicality may not be as clear, the choice of class may be based more on the scientific intent of the protocol or analysis plan or the data structure. \nAll datasets based on any of the general observation classes share a set of common Identifier variables and Timing variables. Three general rules apply when determining which\nvariables to include in a domain:\n\n<\/p>\nThe same set of Identifier variables applies to all domains based on the general observation classes. An optional identifier can be used wherever appropriate.\nAny valid Timing variable is permissible for use in any submission dataset (such as to describe studies with more precise time points such as a Pharmacokinetics trial), but it should be used consistently where applicable for all domains.\nAny additional Qualifier variables from the same general class may be added to a domain model.\n The CDISC standard domain models (SDTMIG 3.2) \nSpecial-Purpose Domains:\n\nComments (CO)\nDemographics (DM)\nSubject Elements (SE)\nSubject Visits (SV)\nInterventions General Observation Class:\n\nConcomitant Medications (CM)\nExposure as Collected (EC)\nExposure (EX)\nSubstance Use (SU)\nProcedures (PR)\nEvents General Observation Class:\n\nAdverse Events (AE)\nClinical Events (CE)\nDisposition (DS)\nProtocol Deviations (DV)\nMedical History (MH)\nHealthcare Encounters (HO)\nFindings General Observation Class:\n\nDrug Accountability (DA)\nDeath Details (DD)\nECG Test Results (EG)\nInclusion\/Exclusion Criterion Not Met (IE)\nImmunogenicity Specimen Assessments (IS)\nLaboratory Test Results (LB)\nMicrobiology Specimen (MB)\nMicroscopic Findings (MI)\nMorphology (MO)\nMicrobiology Susceptibility Test (MS)\nPK Concentrations (PC)\nPK Parameters (PP)\nPhysical Examination (PE)\nQuestionnaires (QS)\nReproductive System Findings (RP)\nDisease Response (RS)\nSubject Characteristics (SC)\nSubject Status (SS)\nTumor Identification (TU)\nTumor Results (TR)\nVital Signs (VS)\nFindings About :\n\nFindings About Events or Interventions (FA)\nSkin Response (SR)\nTrial Design Domains:\n\nTrial Arms (TA)\nTrial Disease Assessment (TD)\nTrial Elements (TE)\nTrial Visits (TV)\nTrial Inclusion\/Exclusion Criteria (TI)\nTrial Summary (TS)\nSpecial-Purpose Relationship Datasets:\n\nSupplemental Qualifiers - SUPPQUAL\nRelate Records - RELREC\nLimitations and Criticism of standards \nOne criticism of the SDTM standards is that they are continually changing, with new versions released frequently. CDISC claims that SDTM standards are backward compatible. But the claim is unreliable. It is not possible to map the data from EDC DBMS to SDTM standards until the clinical trial completes. New domains, for example the exposure as collected (EC) domain, were added recently. However, backward compatibility with earlier domains is not always possible. [1] The standards are not reliable, and well evolved. The controlled terminology is a very small subset of National Cancer institute terminology. [2]\n\nReferences \n\n\n^ Phuse, 2011. \"SDTM Implementation Guide \u2013 Clear as Mud\" (PDF) . lex jansen. PHUSE. Retrieved 17 December 2015 . \n\n^ CDISC, Terminology. \"National Cancer Institute\". cancer.gov. NIH. Retrieved 17 December 2015 . \n\n\nCDISC Study Data Tabulation Model \/ Submission Data Domain Models, Version 3.1\nCDISC Study Data Tabulation Model SDTM Implementation Guide V3.1.1\nStandard for Exchange of Non-clinical Data (SEND)\nSee also \nCDISC\nStandard for Exchange of Non-clinical Data\nExternal links \nStudy Data Tabulation Model at CDISC\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/SDTM\">https:\/\/www.limswiki.org\/index.php\/SDTM<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:45.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 283 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","a75a2a58db1151695c9582ab631ad58a_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-SDTM skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">SDTM<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n<p><b>SDTM<\/b> (<b>Study Data Tabulation Model<\/b>) defines a standard structure for <a href=\"https:\/\/en.wikipedia.org\/wiki\/Human\" title=\"Human\" rel=\"external_link\" target=\"_blank\">human<\/a> clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Food_and_Drug_Administration\" class=\"mw-redirect\" title=\"U.S. Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">United States Food and Drug Administration<\/a> (FDA). The Submission Data Standards team of <a href=\"https:\/\/en.wikipedia.org\/wiki\/Clinical_Data_Interchange_Standards_Consortium\" title=\"Clinical Data Interchange Standards Consortium\" rel=\"external_link\" target=\"_blank\">Clinical Data Interchange Standards Consortium<\/a> (CDISC) defines SDTM.\n<\/p><p>On <b>July 21, 2004<\/b>, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.\n<\/p>\n\n<h2><span class=\"mw-headline\" id=\"Background\">Background<\/span><\/h2>\n<p>SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset or table. Each variable can be classified according to its Role. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into four major roles:\n<\/p>\n<ul><li>Identifier variables, which identify the study, subject of the observation, the domain, and the sequence number of the record<\/li>\n<li>Topic variables, which specify the focus of the observation (such as the name of a lab test)<\/li>\n<li>Timing variables, which describe the timing of the observation (such as start date and end date)<\/li>\n<li>Qualifier variables, which include additional illustrative text, or numeric values that describe the results or additional traits of the observation (such as units or descriptive adjectives).<\/li><\/ul>\n<p>A fifth type of variable role, Rule, can express an algorithm or executable method\nto define start, end, or looping conditions in the Trial Design model.\n<\/p><p>The set of Qualifier variables can be further categorized into five sub-classes:\n<\/p>\n<ul><li>Grouping Qualifiers are used to group together a collection of observations within the same domain. Examples include --CAT and --SCAT.<\/li>\n<li>Result Qualifiers describe the specific results associated with the topic variable for a finding. It is the answer to the question raised by the topic variable. Examples include --ORRES, --STRESC, and --STRESN. Many of the values in the DM domain are also classified as Result Qualifiers.<\/li>\n<li>Synonym Qualifiers specify an alternative name for a particular variable in an observation. Examples include --MODIFY and --DECOD, which are equivalent terms for a --TRT or --TERM topic variable, --TEST and --LOINC which are equivalent terms for a --TESTCD.<\/li>\n<li>Record Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Examples include --REASND, AESLIFE, and all other SAE (serious adverse event) flag variables in the AE domain; and --BLFL, --POS and --LOC, --SPEC, --LOT, --NAM.<\/li>\n<li>Variable Qualifiers are used to further modify or describe a specific variable within an observation and is only meaningful in the context of the variable they qualify. Examples include --ORRESU, --ORNRHI, and --ORNRLO, all of which are variable qualifiers of --ORRES, and --DOSU and --DOSFRM, all of which are variable qualifiers of --DOSE.<\/li><\/ul>\n<p>For example, in the observation, 'Subject 101 had mild nausea starting on Study Day 6,' the Topic variable value is the term for the adverse event, 'NAUSEA'. The Identifier variable is the subject identifier, '101'. The Timing variable is the study day of the start of the event, which captures the information, 'starting on Study Day 6', while an example of a Record Qualifier is the severity, the value for which is 'MILD'.\n<\/p><p>Additional Timing and Qualifier variables could be included to provide the necessary detail to adequately describe an observation.\u2022\tThe SDTM addition to PROC CDISC does not convert existing SDS 2.x content to SDTM 3.x representations.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Datasets_and_domains\">Datasets and domains<\/span><\/h2>\n<p>Observations are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically-related observations with a topic-specific commonality about the subjects in the trial. The logic of the relationship may relate to the scientific matter of the data, or to its role in the trial.\n<\/p><p>Typically, each domain is represented by a dataset, but it is possible to have information relevant to the same topicality spread among multiple datasets. Each dataset is distinguished by a unique, two-character DOMAIN code that should be used consistently throughout the submission. This DOMAIN code is used in the dataset name, the value of the DOMAIN variable within that dataset, and as a prefix for most variable names in the dataset.\n<\/p><p>The dataset structure for observations is a flat file representing a table with one or more rows and columns. Normally, one dataset is submitted for each domain. Each row of the dataset represents a single observation and each column represents one of the variables. Each dataset or table is accompanied by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document named 'Define' that is submitted along with the data to regulatory authorities. \n<\/p><p>Submission Metadata Model uses seven distinct metadata attributes to be defined for each dataset variable in the metadata definition document:\n<\/p>\n<ul><li>The Variable Name (limited to 8-characters for compatibility with the <a href=\"https:\/\/en.wikipedia.org\/wiki\/SAS_System\" class=\"mw-redirect\" title=\"SAS System\" rel=\"external_link\" target=\"_blank\">SAS System<\/a> V5 Transport format)<\/li>\n<li>A descriptive Variable Label, using up to 40 characters, which should be unique for each variable in the dataset<\/li>\n<li>The data Type (e.g., whether the variable value is a character or numeric)<\/li>\n<li>The set of controlled terminology for the value or the presentation format of the variable(Controlled Terms or Format)<\/li>\n<li>The Origin or source of each variable<\/li>\n<li>The Role of the variable, which determines how the variable is used in the dataset. Roles are used to represent the categories of variables as Identifier, Topic, Timing, or the five types of Qualifiers. Since these roles are predefined for all domains that follow the general classes, they do not need to be specified by sponsors in their Define data definition document. Actual submission metadata may use additional role designations, and more than one role may be assigned per variable to meet different needs.<\/li>\n<li>Comments or other relevant information about the variable or its data.<\/li><\/ul>\n<p>Data stored in dataset variables include both raw (as originally collected) and derived values (e.g., converted into standard units, or computed on the basis of multiple values, such as an average). In SDTM only the name, label, and type are listed with a set of CDISC guidelines that provide a general description for each variable used by a general observation class. \n<\/p><p>Comments are included as necessary according to the needs of individual studies.\n<p>The presence of an asterisk (*) in the 'Controlled Terms or Format' column indicates that a discrete set of values (controlled terminology) is expected to be made available for this variable. This set of values may be sponsor-defined in cases where standard vocabularies have not yet been defined (represented by a single *) or from an external published source such as <a href=\"https:\/\/en.wikipedia.org\/wiki\/MedDRA\" title=\"MedDRA\" rel=\"external_link\" target=\"_blank\">MedDRA<\/a> (represented by **).\n\n\u2191\n<\/p>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Special-purpose_domains\">Special-purpose domains<\/span><\/h2>\n<p>The CDISC Version 3.x Submission Data Domain Models include special-purpose domains with a specific\nstructure and cannot be extended with any additional qualifier or timing variables other than those specified. \n<\/p>\n<ul><li>Demographics includes a set of standard variables that describe each subject in a clinical study<\/li>\n<li>Comments describes a fixed structure for recording free-text comments on a subject, or comments related to records or groups of records in other domains.<\/li><\/ul>\n<p>Additional fixed structure, non-extensible special-purpose domains are discussed in the Trial Design model.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"The_general_domain_classes\">The general domain classes<\/span><\/h2>\n<p>Most observations collected during the study (other than those represented in special purpose domains) should be divided among three general observation classes: Interventions, Events, or Findings:\n<\/p>\n<ul><li>The Interventions class captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., \u201cexposure\u201d), coincident with the study assessment period (e.g., \u201cconcomitant medications\u201d), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine)<\/li>\n<li>The Events class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., 'adverse events' or 'disposition') or prior to the trial (e.g., 'medical history').<\/li>\n<li>The Findings class captures the observations resulting from planned evaluations to address specific questions such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires.<\/li><\/ul>\n<p>In most cases, the identification of the general class appropriate to a specific collection of data by topicality is straightforward. Often the Findings general class is the best choice for general observational data collected as measurements or responses to questions. In cases when the topicality may not be as clear, the choice of class may be based more on the scientific intent of the protocol or analysis plan or the data structure. \n<\/p><p>All datasets based on any of the general observation classes share a set of common Identifier variables and Timing variables. Three general rules apply when determining which\n<p>variables to include in a domain:\n<\/p>\n<\/p>\n<ul><li>The same set of Identifier variables applies to all domains based on the general observation classes. An optional identifier can be used wherever appropriate.<\/li>\n<li>Any valid Timing variable is permissible for use in any submission dataset (such as to describe studies with more precise time points such as a Pharmacokinetics trial), but it should be used consistently where applicable for all domains.<\/li>\n<li>Any additional Qualifier variables from the same general class may be added to a domain model.<\/li><\/ul>\n<h2><span id=\"rdp-ebb-The_CDISC_standard_domain_models_.28SDTMIG_3.2.29\"><\/span><span class=\"mw-headline\" id=\"The_CDISC_standard_domain_models_(SDTMIG_3.2)\">The CDISC standard domain models (SDTMIG 3.2)<\/span><\/h2>\n<p><b>Special-Purpose Domains:<\/b>\n<\/p>\n<ul><li>Comments (CO)<\/li>\n<li>Demographics (DM)<\/li>\n<li>Subject Elements (SE)<\/li>\n<li>Subject Visits (SV)<\/li><\/ul>\n<p><b>Interventions General Observation Class:<\/b>\n<\/p>\n<ul><li>Concomitant Medications (CM)<\/li>\n<li>Exposure as Collected (EC)<\/li>\n<li>Exposure (EX)<\/li>\n<li>Substance Use (SU)<\/li>\n<li>Procedures (PR)<\/li><\/ul>\n<p><b>Events General Observation Class:<\/b>\n<\/p>\n<ul><li>Adverse Events (AE)<\/li>\n<li>Clinical Events (CE)<\/li>\n<li>Disposition (DS)<\/li>\n<li>Protocol Deviations (DV)<\/li>\n<li>Medical History (MH)<\/li>\n<li>Healthcare Encounters (HO)<\/li><\/ul>\n<p><b>Findings General Observation Class:<\/b>\n<\/p>\n<ul><li>Drug Accountability (DA)<\/li>\n<li>Death Details (DD)<\/li>\n<li>ECG Test Results (EG)<\/li>\n<li>Inclusion\/Exclusion Criterion Not Met (IE)<\/li>\n<li>Immunogenicity Specimen Assessments (IS)<\/li>\n<li>Laboratory Test Results (LB)<\/li>\n<li>Microbiology Specimen (MB)<\/li>\n<li>Microscopic Findings (MI)<\/li>\n<li>Morphology (MO)<\/li>\n<li>Microbiology Susceptibility Test (MS)<\/li>\n<li>PK Concentrations (PC)<\/li>\n<li>PK Parameters (PP)<\/li>\n<li>Physical Examination (PE)<\/li>\n<li>Questionnaires (QS)<\/li>\n<li>Reproductive System Findings (RP)<\/li>\n<li>Disease Response (RS)<\/li>\n<li>Subject Characteristics (SC)<\/li>\n<li>Subject Status (SS)<\/li>\n<li>Tumor Identification (TU)<\/li>\n<li>Tumor Results (TR)<\/li>\n<li>Vital Signs (VS)<\/li><\/ul>\n<p><b>Findings About :<\/b>\n<\/p>\n<ul><li>Findings About Events or Interventions (FA)<\/li>\n<li>Skin Response (SR)<\/li><\/ul>\n<p><b>Trial Design Domains:<\/b>\n<\/p>\n<ul><li>Trial Arms (TA)<\/li>\n<li>Trial Disease Assessment (TD)<\/li>\n<li>Trial Elements (TE)<\/li>\n<li>Trial Visits (TV)<\/li>\n<li>Trial Inclusion\/Exclusion Criteria (TI)<\/li>\n<li>Trial Summary (TS)<\/li><\/ul>\n<p><b>Special-Purpose Relationship Datasets:<\/b>\n<\/p>\n<ul><li>Supplemental Qualifiers - SUPPQUAL<\/li>\n<li>Relate Records - RELREC<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Limitations_and_Criticism_of_standards\">Limitations and Criticism of standards<\/span><\/h2>\n<p>One criticism of the SDTM standards is that they are continually changing, with new versions released frequently. CDISC claims that SDTM standards are backward compatible. But the claim is unreliable. It is not possible to map the data from EDC DBMS to SDTM standards until the clinical trial completes. New domains, for example the exposure as collected (EC) domain, were added recently. However, backward compatibility with earlier domains is not always possible. <sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup> The standards are not reliable, and well evolved. The controlled terminology is a very small subset of National Cancer institute terminology. <sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist columns references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\">Phuse, 2011. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.lexjansen.com\/phuse\/2011\/cd\/CD02.pdf\" target=\"_blank\">\"SDTM Implementation Guide \u2013 Clear as Mud\"<\/a> <span class=\"cs1-format\">(PDF)<\/span>. <i>lex jansen<\/i>. PHUSE<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">17 December<\/span> 2015<\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=lex+jansen&rft.atitle=SDTM+Implementation+Guide+%E2%80%93+Clear+as+Mud&rft.aulast=Phuse&rft.aufirst=2011&rft_id=http%3A%2F%2Fwww.lexjansen.com%2Fphuse%2F2011%2Fcd%2FCD02.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASDTM\" class=\"Z3988\"><\/span><\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-2\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\">CDISC, Terminology. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cancer.gov\/research\/resources\/terminology\/cdisc\" target=\"_blank\">\"National Cancer Institute\"<\/a>. <i>cancer.gov<\/i>. NIH<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">17 December<\/span> 2015<\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=cancer.gov&rft.atitle=National+Cancer+Institute&rft.aulast=CDISC&rft.aufirst=Terminology&rft_id=http%3A%2F%2Fwww.cancer.gov%2Fresearch%2Fresources%2Fterminology%2Fcdisc&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASDTM\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<\/ol><\/div>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20071027092920\/http:\/\/www.cdisc.org\/models\/sds\/v3.1\/index.html\" target=\"_blank\">CDISC Study Data Tabulation Model \/ Submission Data Domain Models, Version 3.1<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20080612045554\/http:\/\/www.cdisc.org\/models\/sdtm\/v1.1\/index.html\" target=\"_blank\">CDISC Study Data Tabulation Model SDTM Implementation Guide V3.1.1<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Standard_for_Exchange_of_Non-clinical_Data_(SEND)\" class=\"mw-redirect\" title=\"Standard for Exchange of Non-clinical Data (SEND)\" rel=\"external_link\" target=\"_blank\">Standard for Exchange of Non-clinical Data (SEND)<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/CDISC\" class=\"mw-redirect\" title=\"CDISC\" rel=\"external_link\" target=\"_blank\">CDISC<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Standard_for_Exchange_of_Non-clinical_Data\" title=\"Standard for Exchange of Non-clinical Data\" rel=\"external_link\" target=\"_blank\">Standard for Exchange of Non-clinical Data<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdisc.org\/sdtm\" target=\"_blank\">Study Data Tabulation Model<\/a> at CDISC<\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1265\nCached time: 20181129153722\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.144 seconds\nReal time usage: 0.190 seconds\nPreprocessor visited node count: 410\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 11466\/2097152 bytes\nTemplate argument size: 186\/2097152 bytes\nHighest expansion depth: 12\/40\nExpensive parser function count: 2\/500\nUnstrip recursion depth: 1\/20\nUnstrip post\u2010expand size: 5083\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.078\/10.000 seconds\nLua memory usage: 2.07 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 165.462 1 -total\n<\/p>\n<pre>52.27% 86.493 1 Template:Reflist\n46.29% 76.585 2 Template:Cite_web\n41.32% 68.375 1 Template:No_footnotes\n28.33% 46.871 2 Template:Ambox\n 5.12% 8.471 1 Template:Primary_sources\n 3.01% 4.978 2 Template:Yesno-no\n 1.81% 2.994 2 Template:Main_other\n 1.70% 2.807 2 Template:Yesno\n 1.20% 1.988 1 Template:Column-width\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:18408210-1!canonical and timestamp 20181129153722 and revision id 842130457\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/SDTM\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205340\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.011 seconds\nReal time usage: 0.166 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 159.546 1 - wikipedia:SDTM\n100.00% 159.546 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9174-0!*!*!*!*!*!* and timestamp 20181217205340 and revision id 27133\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/SDTM\">https:\/\/www.limswiki.org\/index.php\/SDTM<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","a75a2a58db1151695c9582ab631ad58a_images":["https:\/\/upload.wikimedia.org\/wikipedia\/en\/thumb\/9\/99\/Question_book-new.svg\/100px-Question_book-new.svg.png"],"a75a2a58db1151695c9582ab631ad58a_timestamp":1545080020,"142f393618194fc1363637102e13b8b0_type":"article","142f393618194fc1363637102e13b8b0_title":"SCRIPT (medicine)","142f393618194fc1363637102e13b8b0_url":"https:\/\/www.limswiki.org\/index.php\/SCRIPT_(medicine)","142f393618194fc1363637102e13b8b0_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tSCRIPT (medicine)\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tSCRIPT is a standard promulgated by the National Council for Prescription Drug Programs (NCPDP) for the electronically transmitted medical prescriptions in the United States.\n\nAdoption \nThe first version of SCRIPT was approved in 1997. Version 8.1 was proposed as a federal rule by the Centers for Medicare and Medicaid Services (\"CMS\") in November, 2007, and adopted in 2008, thereby mandating its use for medical providers that used electronic subscriptions, in order to obtain federal insurance reimbursement.[1] A new \"backwards-compatible\"version, 10.1, was adopted by the Surescripts pharmacy consortium in late 2009,[2] to help its members participate in the electronic medical record incentive programs under the HITECH Act. It was proposed by CMS as a rule in June, 2010.[3]\n\nReferences \n\n\n^ \"CMS Proposes More E-Script Standards\". Health Data Management. 2007-11-15. \n\n^ \"Surescripts Plans on Adopting NCPDP SCRIPT 10.6 Standard in Support of Meaningful EHR Use\". HealthIT News Direct. 2009-10-16. \n\n^ \"CMS OKs Updated E-Script Standard\". Health Data Management. 2010-06-29. \n\n\nExternal links \nNCPDP standards page\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/SCRIPT_(medicine)\">https:\/\/www.limswiki.org\/index.php\/SCRIPT_(medicine)<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:45.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 174 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","142f393618194fc1363637102e13b8b0_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-SCRIPT_medicine skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">SCRIPT (medicine)<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><b>SCRIPT<\/b> is a standard promulgated by the <a href=\"https:\/\/en.wikipedia.org\/wiki\/National_Council_for_Prescription_Drug_Programs\" title=\"National Council for Prescription Drug Programs\" rel=\"external_link\" target=\"_blank\">National Council for Prescription Drug Programs (NCPDP)<\/a> for the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electronic_prescribing\" title=\"Electronic prescribing\" rel=\"external_link\" target=\"_blank\">electronically transmitted medical prescriptions<\/a> in the United States.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Adoption\">Adoption<\/span><\/h2>\n<p>The first version of SCRIPT was approved in 1997. Version 8.1 was proposed as a <a href=\"https:\/\/en.wikipedia.org\/wiki\/Rulemaking\" title=\"Rulemaking\" rel=\"external_link\" target=\"_blank\">federal rule<\/a> by the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" rel=\"external_link\" target=\"_blank\">Centers for Medicare and Medicaid Services<\/a> (\"CMS\") in November, 2007, and adopted in 2008, thereby mandating its use for medical providers that used electronic subscriptions, in order to obtain federal insurance reimbursement.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup> A new \"<a href=\"https:\/\/en.wikipedia.org\/wiki\/Backwards-compatible\" class=\"mw-redirect\" title=\"Backwards-compatible\" rel=\"external_link\" target=\"_blank\">backwards-compatible<\/a>\"version, 10.1, was adopted by the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Surescripts\" title=\"Surescripts\" rel=\"external_link\" target=\"_blank\">Surescripts<\/a> pharmacy consortium in late 2009,<sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup> to help its members participate in the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electronic_medical_record\" class=\"mw-redirect\" title=\"Electronic medical record\" rel=\"external_link\" target=\"_blank\">electronic medical record<\/a> incentive programs under the <a href=\"https:\/\/en.wikipedia.org\/wiki\/HITECH_Act\" class=\"mw-redirect\" title=\"HITECH Act\" rel=\"external_link\" target=\"_blank\">HITECH Act<\/a>. It was proposed by CMS as a rule in June, 2010.<sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation news\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthdatamanagement.com\/news\/physicians_electronic_prescribing_Medicare_standards25197-1.html\" target=\"_blank\">\"CMS Proposes More E-Script Standards\"<\/a>. <i>Health Data Management<\/i>. 2007-11-15.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Health+Data+Management&rft.atitle=CMS+Proposes+More+E-Script+Standards&rft.date=2007-11-15&rft_id=http%3A%2F%2Fwww.healthdatamanagement.com%2Fnews%2Fphysicians_electronic_prescribing_Medicare_standards25197-1.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASCRIPT+%28medicine%29\" class=\"Z3988\"><\/span><\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-2\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation news\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthnewsdirect.com\/?p=30\" target=\"_blank\">\"Surescripts Plans on Adopting NCPDP SCRIPT 10.6 Standard in Support of Meaningful EHR Use\"<\/a>. HealthIT News Direct. 2009-10-16.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Surescripts+Plans+on+Adopting+NCPDP+SCRIPT+10.6+Standard+in+Support+of+Meaningful+EHR+Use&rft.date=2009-10-16&rft_id=http%3A%2F%2Fwww.healthnewsdirect.com%2F%3Fp%3D30&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASCRIPT+%28medicine%29\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-3\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation news\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthdatamanagement.com\/news\/electronic-prescribing-standard-Medicare-40574-1.html\" target=\"_blank\">\"CMS OKs Updated E-Script Standard\"<\/a>. Health Data Management. 2010-06-29.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=CMS+OKs+Updated+E-Script+Standard&rft.date=2010-06-29&rft_id=http%3A%2F%2Fwww.healthdatamanagement.com%2Fnews%2Felectronic-prescribing-standard-Medicare-40574-1.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASCRIPT+%28medicine%29\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncpdp.org\/Standards-Development\/Standards-Information\" target=\"_blank\">NCPDP standards page<\/a><\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1270\nCached time: 20181216045228\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.096 seconds\nReal time usage: 0.124 seconds\nPreprocessor visited node count: 170\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 4111\/2097152 bytes\nTemplate argument size: 81\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/500\nUnstrip recursion depth: 1\/20\nUnstrip post\u2010expand size: 7488\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.054\/10.000 seconds\nLua memory usage: 1.69 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 110.656 1 Template:Reflist\n100.00% 110.656 1 -total\n<\/p>\n<pre>85.24% 94.318 3 Template:Cite_news\n 2.35% 2.602 1 Template:Main_other\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:28322759-1!canonical and timestamp 20181216045228 and revision id 832119646\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/SCRIPT_%28medicine%29\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205339\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.169 seconds\nReal time usage: 0.278 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 266.838 1 - wikipedia:SCRIPT_(medicine)\n100.00% 266.838 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9173-0!*!*!*!*!*!* and timestamp 20181217205339 and revision id 27132\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/SCRIPT_(medicine)\">https:\/\/www.limswiki.org\/index.php\/SCRIPT_(medicine)<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","142f393618194fc1363637102e13b8b0_images":[],"142f393618194fc1363637102e13b8b0_timestamp":1545080019,"cc53f4321e9cd423da3cd2d4d9b0ee8b_type":"article","cc53f4321e9cd423da3cd2d4d9b0ee8b_title":"OpenXDF","cc53f4321e9cd423da3cd2d4d9b0ee8b_url":"https:\/\/www.limswiki.org\/index.php\/OpenXDF","cc53f4321e9cd423da3cd2d4d9b0ee8b_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tOpenXDF\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tOpenXDFFilename extension.xdfUniform Type Identifier (UTI)org.openxdf.xdfLatest release1.2\r\n(June 30, 2009) Type of formatElectroencephalography and Polysomnography\nThe Open eXchange Data Format, or OpenXDF, is an open, XML-based standard for the digital storage and exchange of time-series physiological signals and metadata. OpenXDF primarily focuses on electroencephalography and polysomnography.\n\nContents \n\n1 History \n2 Features \n\n2.1 Tiered structure \n2.2 Metadata \n2.3 Unicode support \n2.4 Signal configuration \n2.5 Security \n\n\n3 See also \n4 References \n5 External links \n\n\nHistory \nNeurotronics began work on OpenXDF in 2003 with the goal of providing a modern, open, and extensible file format with which clinicians and researchers can share physiological data and metadata, such as signal data, signal montages, patient demographics, and event logs.[citation needed ]\nNeurotronics released the first draft of the OpenXDF Specification just before the 18th meeting of the Associated Professional Sleep Societies in 2004. Neurotronics has since relinquished control of the format to the OpenXDF Consortium.\nAs of version 1.0, OpenXDF is 100% backward compatible with the European Data Format (EDF), the current de facto standard format for physiological data exchange.\n\nFeatures \nTiered structure \nOpenXDF is a tiered framework designed to allow standardized and custom specializations of the format while enforcing a common foundation that provides a high-level of compatibility between unrelated systems.\n\nMetadata \nOpenXDF expands on EDF by providing standardized support for extensive patient information, display montages, annotations, and scoring information.\n\nUnicode support \nOpenXDF requires the use of a XML 1.0 compliant parser that supports UTF-8 and UTF-16.\n\nSignal configuration \nOpenXDF supports fully and independently configurable data signals. Each signal specifies its byte order, whether its samples are signed, the size of its samples, and its sampling rate.\n\nSecurity \nOpenXDF supports encryption of the XML file using TwoFish in Cipher Feedback (CFB) mode with a 256-bit key created from a UTF-8 encoded password hashed with SHA-256. In addition, OpenXDF supports integrity verification using a SHA-512 hash of the original XML file.\n\nSee also \nEuropean Data Format (EDF)\nReferences \n\n\n\nOpenXDF Web Site\nOpenXDF Specification\n\nExternal links \nEuropean Data Format (EDF) Specifications\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/OpenXDF\">https:\/\/www.limswiki.org\/index.php\/OpenXDF<\/a>\n\t\t\t\t\tCategories: File format and transfer standardsHealth informaticsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 18 August 2016, at 19:40.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 202 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","cc53f4321e9cd423da3cd2d4d9b0ee8b_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-OpenXDF skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">OpenXDF<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n<p>The Open eXchange Data Format, or <b>OpenXDF<\/b>, is an open, <a href=\"https:\/\/en.wikipedia.org\/wiki\/XML\" title=\"XML\" rel=\"external_link\" target=\"_blank\">XML<\/a>-based standard for the digital storage and exchange of time-series physiological signals and metadata. OpenXDF primarily focuses on <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electroencephalography\" title=\"Electroencephalography\" rel=\"external_link\" target=\"_blank\">electroencephalography<\/a> and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Polysomnography\" title=\"Polysomnography\" rel=\"external_link\" target=\"_blank\">polysomnography<\/a>.\n<\/p>\n\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<p> began work on OpenXDF in 2003 with the goal of providing a modern, open, and extensible file format with which clinicians and researchers can share physiological data and metadata, such as signal data, signal montages, patient demographics, and event logs.<sup class=\"noprint Inline-Template Template-Fact\" style=\"white-space:nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Citation_needed\" title=\"Wikipedia:Citation needed\" rel=\"external_link\" target=\"_blank\"><span title=\"This claim needs references to reliable sources. (September 2009)\">citation needed<\/span><\/a><\/i>]<\/sup>\n<\/p><p> released the first draft of the OpenXDF Specification just before the 18th meeting of the in 2004. has since relinquished control of the format to the .\n<\/p><p>As of version 1.0, OpenXDF is 100% backward compatible with the <a href=\"https:\/\/en.wikipedia.org\/wiki\/European_data_format\" class=\"mw-redirect\" title=\"European data format\" rel=\"external_link\" target=\"_blank\">European Data Format (EDF)<\/a>, the current de facto standard format for physiological data exchange.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Features\">Features<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"Tiered_structure\">Tiered structure<\/span><\/h3>\n<p>OpenXDF is a tiered framework designed to allow standardized and custom specializations of the format while enforcing a common foundation that provides a high-level of compatibility between unrelated systems.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Metadata\">Metadata<\/span><\/h3>\n<p>OpenXDF expands on EDF by providing standardized support for extensive patient information, display montages, annotations, and scoring information.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Unicode_support\">Unicode support<\/span><\/h3>\n<p>OpenXDF requires the use of a XML 1.0 compliant parser that supports <a href=\"https:\/\/en.wikipedia.org\/wiki\/UTF-8\" title=\"UTF-8\" rel=\"external_link\" target=\"_blank\">UTF-8<\/a> and <a href=\"https:\/\/en.wikipedia.org\/wiki\/UTF-16\" title=\"UTF-16\" rel=\"external_link\" target=\"_blank\">UTF-16<\/a>.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Signal_configuration\">Signal configuration<\/span><\/h3>\n<p>OpenXDF supports fully and independently configurable data signals. Each signal specifies its byte order, whether its samples are signed, the size of its samples, and its sampling rate.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Security\">Security<\/span><\/h3>\n<p>OpenXDF supports encryption of the XML file using <a href=\"https:\/\/en.wikipedia.org\/wiki\/TwoFish\" class=\"mw-redirect\" title=\"TwoFish\" rel=\"external_link\" target=\"_blank\">TwoFish<\/a> in <a href=\"https:\/\/en.wikipedia.org\/wiki\/Cipher_feedback\" class=\"mw-redirect\" title=\"Cipher feedback\" rel=\"external_link\" target=\"_blank\">Cipher Feedback (CFB)<\/a> mode with a 256-bit key created from a UTF-8 encoded password hashed with <a href=\"https:\/\/en.wikipedia.org\/wiki\/SHA-256\" class=\"mw-redirect\" title=\"SHA-256\" rel=\"external_link\" target=\"_blank\">SHA-256<\/a>. In addition, OpenXDF supports integrity verification using a <a href=\"https:\/\/en.wikipedia.org\/wiki\/SHA-512\" class=\"mw-redirect\" title=\"SHA-512\" rel=\"external_link\" target=\"_blank\">SHA-512<\/a> hash of the original XML file.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/European_Data_Format\" title=\"European Data Format\" rel=\"external_link\" target=\"_blank\">European Data Format<\/a> (EDF)<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<\/div>\n<div class=\"refbegin\" style=\"\">\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.openxdf.org\" target=\"_blank\">OpenXDF Web Site<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.openxdf.org\/spec.php\" target=\"_blank\">OpenXDF Specification<\/a><\/li><\/ul>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.edfplus.info\" target=\"_blank\">European Data Format (EDF) Specifications<\/a><\/li><\/ul>\n<p><!-- \nNewPP limit report\nParsed by mw1326\nCached time: 20181128142750\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.116 seconds\nReal time usage: 0.174 seconds\nPreprocessor visited node count: 547\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 5942\/2097152 bytes\nTemplate argument size: 876\/2097152 bytes\nHighest expansion depth: 13\/40\nExpensive parser function count: 1\/500\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 464\/5000000 bytes\nNumber of Wikibase entities loaded: 0\/400\nLua time usage: 0.037\/10.000 seconds\nLua memory usage: 1.35 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 155.774 1 -total\n<\/p>\n<pre>44.53% 69.362 1 Template:Infobox_file_format\n39.94% 62.220 1 Template:Citation_needed\n35.90% 55.929 1 Template:Fix\n35.40% 55.145 1 Template:Infobox\n24.47% 38.123 2 Template:Category_handler\n10.37% 16.152 1 Template:Refbegin\n 8.96% 13.950 1 Template:Delink\n 5.60% 8.721 1 Template:Longitem\n 3.76% 5.864 1 Template:Smaller\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:14693313-1!canonical and timestamp 20181128142750 and revision id 725743972\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/OpenXDF\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217205339\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.010 seconds\nReal time usage: 0.143 seconds\nPreprocessor visited node count: 5\/1000000\nPreprocessor generated node count: 20\/1000000\nPost\u2010expand include size: 20\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 137.669 1 - wikipedia:OpenXDF\n100.00% 137.669 1 - -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:9172-0!*!*!*!*!*!* and timestamp 20181217205338 and revision id 27131\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/OpenXDF\">https:\/\/www.limswiki.org\/index.php\/OpenXDF<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","cc53f4321e9cd423da3cd2d4d9b0ee8b_images":[],"cc53f4321e9cd423da3cd2d4d9b0ee8b_timestamp":1545080018,"3637b0e53dc77a8ca4076a4ab81f4172_type":"article","3637b0e53dc77a8ca4076a4ab81f4172_title":"Nursing Minimum Data Set","3637b0e53dc77a8ca4076a4ab81f4172_url":"https:\/\/www.limswiki.org\/index.php\/Nursing_Minimum_Data_Set","3637b0e53dc77a8ca4076a4ab81f4172_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tNursing Minimum Data Set\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThe Nursing Minimum Data Set (NMDS) is a classification system which allows for the standardized collection of essential nursing data. The collected data are meant to provide an accurate description of the nursing process used when providing nursing care. The NMDS allow for the analysis and comparison of nursing data across populations, settings, geographic areas, and time.[1][2]\n\nSee also \n\n\n Nursing portal \nEffective therapeutic regimen management\nMinimum Data Set\nNANDA\nNursing care plan\nNursing assessment\nNursing diagnosis\nNursing Interventions Classification (NIC)\nNursing Outcomes Classification (NOC)\nOmaha System\nReferences \n\n\n^ Werley, HH; Devine, EC; Zorn, CR; Ryan, P; Westra, BL (April 1991). \"The Nursing Minimum Data Set: abstraction tool for standardized, comparable, essential data\". American Journal of Public Health. 81 (4): 421\u2013426. doi:10.2105\/ajph.81.4.421. PMC 1405031 . PMID 2003618. \n\n^ Williams, CA (April 1991). \"The Nursing Minimum Data Set: a major priority for public health nursing but not a panacea\". American Journal of Public Health. 81 (4): 413\u2013414. doi:10.2105\/ajph.81.4.413. PMC 1405046 . PMID 2003616. \n\n\nExternal links \nDenehy, Janice (January 2012). \"Nursing Minimum Data Set for School Nursing Practice: Position Statement\". National Association of School Nurses. Retrieved 25 August 2014 . \nvteNursingLevels of practiceGeneralists\nStudent nurse\nClinical nurse leader\nLicensed practical nurse\nRegistered nurse\nGraduate nurse\nAdvanced practiceAPRNs by role\nClinical nurse specialist\nNurse anesthetist\nNurse midwife\nNurse practitioner\nNPs by Population\nFamily\nAdult-Gerontology\nPediatrics\nWomen's health\nNeonatal\nPsych\/Mental health\nEducation \r\n and licensure\nNightingale Pledge\nAssociate of Science in Nursing\nBachelor of Science in Nursing\nDiploma in Nursing\nDoctor of Nursing Practice\nMaster of Science in Nursing\nBoard of nursing\nNurse Licensure Compact\nNursing credentials and certifications\nNursing school\nNurse registry\nNCLEX\nTEAS\nSpecialties and \r\n areas of practice\nAmbulatory care\nCardiac\nCorrectional nursing\nCritical care\nDental\nEducation\nEmergency\nFaith community\nFlight\nForensic\nGeriatrics\nHolistic\nHome health\nHyperbaric\nLegal consultation\nManagement\nMatron\nMedical-surgical\nMidwifery\nMilitary\nNeonatal\nNursing informatics\nObstetrics\nOccupational health\nOncology\nOrthopedics\nPediatrics\nPerianesthesia\nPerioperative\nPsychiatric and mental health\nPrivate duty\nPublic health\nSchool\nSpace\nSurgical\nTelenursing\nTravel health nursing\nWOCN\nNursing process\nNursing assessment\nNursing diagnosis\nNursing care plan\nNursing theory\nClassification \r\n systems\nNANDA\nNursing Interventions Classification\nNursing Minimum Data Set (NMDS)\nNursing Outcomes Classification\nBy country\nInternational Nurses Day\nAustralia (timeline)\nCanada\nGermany\nHong Kong\nIndia\nJapan\nKenya\nNew Zealand (timeline)\nPakistan\nPhilippines\nRepublic of Ireland\nSouth Africa\nTaiwan\nUnited Kingdom (history)\nUnited States (history)\n\n Category\n Commons\n Portal\n WikiProject\n\n\r\n\n\nThis nursing-related article is a stub. 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The collected data are meant to provide an accurate description of the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_process\" title=\"Nursing process\" rel=\"external_link\" target=\"_blank\">nursing process<\/a> used when providing <a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_care\" class=\"mw-redirect\" title=\"Nursing care\" rel=\"external_link\" target=\"_blank\">nursing care<\/a>. The NMDS allow for the analysis and comparison of nursing data across populations, settings, geographic areas, and time.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\" rel=\"external_link\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<div role=\"navigation\" aria-label=\"Portals\" class=\"noprint portal plainlist tright\" style=\"margin:0.5em 0 0.5em 1em;border:solid #aaa 1px\">\n<ul style=\"display:table;box-sizing:border-box;padding:0.1em;max-width:175px;background:#f9f9f9;font-size:85%;line-height:110%;font-style:italic;font-weight:bold\">\n<li style=\"display:table-row\"><span style=\"display:table-cell;padding:0.2em;vertical-align:middle;text-align:center\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Nursing_symbol.svg\" class=\"image\" rel=\"external_link\" target=\"_blank\"><img alt=\"icon\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/f\/f2\/Nursing_symbol.svg\/32px-Nursing_symbol.svg.png\" width=\"32\" height=\"23\" class=\"noviewer\" \/><\/a><\/span><span style=\"display:table-cell;padding:0.2em 0.2em 0.2em 0.3em;vertical-align:middle\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/Portal:Nursing\" title=\"Portal:Nursing\" rel=\"external_link\" target=\"_blank\">Nursing portal<\/a><\/span><\/li><\/ul><\/div>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Effective_therapeutic_regimen_management\" title=\"Effective therapeutic regimen management\" rel=\"external_link\" target=\"_blank\">Effective therapeutic regimen management<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Minimum_Data_Set\" title=\"Minimum Data Set\" rel=\"external_link\" target=\"_blank\">Minimum Data Set<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/NANDA\" title=\"NANDA\" rel=\"external_link\" target=\"_blank\">NANDA<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_care_plan\" title=\"Nursing care plan\" rel=\"external_link\" target=\"_blank\">Nursing care plan<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_assessment\" title=\"Nursing assessment\" rel=\"external_link\" target=\"_blank\">Nursing assessment<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_diagnosis\" title=\"Nursing diagnosis\" rel=\"external_link\" target=\"_blank\">Nursing diagnosis<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_Interventions_Classification\" title=\"Nursing Interventions Classification\" rel=\"external_link\" target=\"_blank\">Nursing Interventions Classification<\/a> (NIC)<\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Nursing_Outcomes_Classification\" title=\"Nursing Outcomes Classification\" rel=\"external_link\" target=\"_blank\">Nursing Outcomes Classification<\/a> (NOC)<\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Omaha_System\" title=\"Omaha System\" rel=\"external_link\" target=\"_blank\">Omaha System<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-1\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Werley, HH; Devine, EC; Zorn, CR; Ryan, P;
