{"id":460,"date":"2023-10-03T13:02:01","date_gmt":"2023-10-03T20:02:01","guid":{"rendered":"https:\/\/irisstatcomp.com\/blog\/?p=460"},"modified":"2023-10-03T13:02:01","modified_gmt":"2023-10-03T20:02:01","slug":"si-and-conventional-units","status":"publish","type":"post","link":"https:\/\/irisstatcomp.com\/blog\/?p=460","title":{"rendered":"SI and Conventional Units?"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"577\" src=\"https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-1024x577.jpg\" alt=\"\" class=\"wp-image-461\" srcset=\"https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-1024x577.jpg 1024w, https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-300x169.jpg 300w, https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-768x432.jpg 768w, https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-1536x865.jpg 1536w, https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain-1200x676.jpg 1200w, https:\/\/irisstatcomp.com\/blog\/wp-content\/uploads\/2023\/10\/LCDomain.jpg 1920w\" sizes=\"auto, (max-width: 709px) 85vw, (max-width: 909px) 67vw, (max-width: 1362px) 62vw, 840px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p id=\"ember110\">Lab results in International System of Units (SI) have been the requirement for FDA data submissions. However, FDA has sometimes requested data in conventional units for labeling purposes.\u00a0The last\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/study-data-technical-conformance-guide-technical-specifications-document\">FDA Study Data TCG<\/a>\u00a0has changed a &#8220;may require&#8221; to a &#8220;please submit&#8221; for conventional units. This topic has made its rounds through\u00a0<a href=\"https:\/\/www.cdisc.org\/kb\/articles\/standardized-lab-units\">CDISC<\/a>\u00a0Sub-teams and PHUSE working groups. Seems FDA has sorted it out with providing the additional instruction to submit in a custom domain. Has anybody out there added the lc.xpt dataset to their eSubmission data packages yet?<\/p>\n\n\n\n<p id=\"ember111\">Let me know what you&#8217;ve learned.<\/p>\n\n\n\n<p id=\"ember112\">Lisa<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For clinical studies, FDA says &#8220;please submit two domains for lab results.&#8221; They are asking for both the previously expected SI units and now the conventional units.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[19,10,15,17,20,28],"class_list":["post-460","post","type-post","status-publish","format-standard","hentry","category-data-standards","tag-cdisc","tag-clinical-research","tag-drug-development","tag-fda","tag-phuse","tag-sdtm"],"_links":{"self":[{"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/460","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=460"}],"version-history":[{"count":1,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/460\/revisions"}],"predecessor-version":[{"id":462,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/460\/revisions\/462"}],"wp:attachment":[{"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=460"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=460"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/irisstatcomp.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=460"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}