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911 articles found
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Domains are Topic-based, Except When They're Based on StructureFor an implementer trying to decide where data belong in SDTM-based datasets, it's pretty clear when data belongs in a trial design dataset, a relationship dataset, one of the new study reference data... -
Controlled Terminology: FAQs1. Who makes Controlled Terminology? You do! Controlled Terminology is developed from user requests, as well as requests from the CDISC Foundational and Therapeutic Area teams, which comprise volunt...
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Study Subject vs. Experimental UnitThe BRIDG model makes a distinction between a study subject and an experimental unit. In most studies for which SDTM is implemented, these terms refer to the same person or animal, but there are stud...
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CDISC-Annotated CRF Repository in JapaneseA Summary of the ProjectThe Japan Agency for Medical Research and Development (AMED) was established in 2015 for the advancement of medical discoveries that make life better for everyone. Working und...
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Why is an Image like a Specimen?If you're trying to figure out how to represent imaging data in SDTM, it may be helpful to think about the similarities between an image and a specimen. A sample taken from a subject for testing at...
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Special Values: "MULTIPLE" and "OTHER"The SDTMIG directs that, under certain circumstances, variables can be populated with the values "MULTIPLE" or "OTHER". Neither of these values is what might be called a "proper" value for the variabl...
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Does QNAM Need to Start with a Domain Code?The QNAM values that appear in various examples published in the SDTMIG and TAUGs have sometimes included the domain code, and sometimes not. The SDTMIG Appendix for Supplemental Qualifiers Name Codes...
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The Magic that Happens between CDASH and SDTMOn occasion the mapping from CDASH to SDTM is complex. This article provides a step-by-step explanation to help follow the iteration from the CDASH example to the SDTM example. The Clinical Data A...
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Coronavirus (COVID-19) Update: December 10, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On December 9, 2021, the FDA updated the SARS-CoV-2 Viral Muta...
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FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of CareThe following quote is attributed to CDRH’s William Maisel, M.D.,M.P.H., director of the Office of Product Evaluation and Quality and Ed Margerrison, Ph.D., director of the Office of Science an...