Transcription of automated, replicable CDISC conversion
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automated, replicable CDISC conversion
automated , replicable CDISC conversionTamr for CDISC WhitepaperAbstractAbout CDISCThe Complexity of CDISC and SASHow Tamr solves CDISC problems+ data Loading+ automated Transformation & Matching+ Expert Questions & Active Learning+ Validation & data ExportBenefitsDetailed workflow+ Catalog study data + Domain Assignment+ Variable Mapping+ Transformations+ Validation+ data ExportCore features+ Active Learning+ Expert Sourcing+ Logging and Auditing+ Programmatic APIsReferencesAbstract In the United States, the FDA requires that every clinical trial or application to market a new drug or biologic be accompanied by clinical study data showing the safety and efficacy of the proposed product. Converting clinical data into the FDA-required CDISC standards is a difficult, time-consuming and error-prone process; if not done correctly, the FDA might refuse to file the application, or send it back to the sponsoring organization for correction.
automated, replicable CDISC conversion Tamr for CDISC Whitepaper Abstract About CDISC ... and analytic results derived from that data (the Study Data Tabulation Model, or SDTM, and the Analysis Data Model, or ADaM), sponsors ... accepts for clinical study data is the XPORT (Transport) file format, an archaic format used as an interchange . 3
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