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- SDTM abstract "SDTM (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.On 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.".
- SDTM wikiPageExternalLink index.html.
- SDTM wikiPageExternalLink index.html.
- SDTM wikiPageExternalLink sdtm.
- SDTM wikiPageID "18408210".
- SDTM wikiPageRevisionID "586769553".
- SDTM hasPhotoCollection SDTM.
- SDTM subject Category:Clinical_trials.
- SDTM subject Category:Food_and_Drug_Administration.
- SDTM subject Category:Health_standards.
- SDTM type Abstraction100002137.
- SDTM type Act100030358.
- SDTM type Activity100407535.
- SDTM type Attempt100786195.
- SDTM type ClinicalTrial100792356.
- SDTM type ClinicalTrials.
- SDTM type Event100029378.
- SDTM type HealthStandards.
- SDTM type Measure100033615.
- SDTM type PsychologicalFeature100023100.
- SDTM type Standard107260623.
- SDTM type SystemOfMeasurement113577171.
- SDTM type Test100791078.
- SDTM type YagoPermanentlyLocatedEntity.
- SDTM comment "SDTM (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).".
- SDTM label "SDTM".
- SDTM sameAs m.04f5kth.
- SDTM sameAs Q7389491.
- SDTM sameAs Q7389491.
- SDTM sameAs SDTM.
- SDTM wasDerivedFrom SDTM?oldid=586769553.
- SDTM isPrimaryTopicOf SDTM.