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911 articles found
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Considerations for Using CDISC Standards in Observational StudiesPHUSE US Connect 2019 Paper SI08 Considerations for Using CDISC Standards in Observational Studies Jon Neville, CDISC, Austin, TX, USA Bess LeRoy, CDISC, Austin, TX, USA ABSTRACT Historically, C... -
SDTM Timing Variables for Pre-study FindingsData about medical history and prior meds are often collected at an initial study visit. Records in an SDTM-based dataset for these events and interventions will include information about their starts...
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Domain vs. Dataset: What's the Difference?The terms “domain” and “dataset” are commonly used in CDISC’s nomenclature and found frequently in the Study Data Tabulation Model (SDTM). For example, the SDTM v1.8 includes 134 instances of domain”...
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A Short History of CDISC and SAS Transport FilesBackground When development of the SDTM and SDTMIG started, SAS was in almost universal use in the pharmaceutical industry and at FDA. "The SAS® Version 5 (V5) transport file format is an open stand...
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Why Not Just Use SNOMED?SNOMED (short for SNOMED Clinical Terms or SNOMED CT) is a set of medical terms used widely in clinical practice. Some have asked why CDISC develops its own Controlled Terminology, rather than using S...
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Sex and Gender"Sex" and "gender" are similar but different concepts whose definitions and meanings can be confusing (see, for example, the article Sex and gender: What is the difference? from Medical News Today). T...
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Use of FHIR in Clinical Research: From Electronic Medical Records to AnalysisPHUSE US Connect 2019 Priya Gopal, TESARO, Waltham, MA, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Sam Hume, CDISC, State College, PA, USA ABSTRACT In two previous papers, the PhUSE working...
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Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms using a CDISC ODM APISam Hume, CDISC, State College, PA, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Geoff Low, Medidata Solutions, London, UK ABSTRACT Use of Fast Healthcare Interoperability Resources (FHIR) in t...
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Standardized Lab UnitsThe International System of Units (SI), commonly known as the metric system, is the international standard for measurement. According to the National Institute of Science and Technology (NIST), the SI...
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Changing Event SeverityIn the diagrams below, the red line represents a graph of severity over time for a hypothetical event. For most adverse events, severity cannot be measured on a continuous scale; this line represents...