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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.

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rdf:type	yago:WikicatClinicalTrials yago:Abstraction100002137 yago:Act100030358 yago:Activity100407535 yago:Attempt100786195 yago:ClinicalTrial100792356 yago:Event100029378 yago:Measure100033615 yago:PsychologicalFeature100023100 yago:WikicatHealthStandards yago:YagoPermanentlyLocatedEntity yago:Standard107260623 yago:SystemOfMeasurement113577171 yago:Test100791078
rdfs:label	SDTM (en)
rdfs: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). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. (en)
dct:subject	Health standards Clinical trials Food and Drug Administration
Wikipage page ID	18408210 (xsd:integer)
Wikipage revision ID	1087620706 (xsd:integer)
Link from a Wikipage to another Wikipage	Health standards Human Clinical Data Interchange Standards Consortium MedDRA U.S. Food and Drug Administration Clinical trials Food and Drug Administration Standard for Exchange of Non-clinical Data SAS System
Link from a Wikipage to an external page	http://www.cdisc.org/sdtm https://web.archive.org/web/20071027092920/http:/www.cdisc.org/models/sds/v3.1/index.html https://web.archive.org/web/20080612045554/http:/www.cdisc.org/models/sdtm/v1.1/index.html
sameAs	SDTM SDTM SDTM SDTM
dbp:wikiPageUsesTemplate	dbt:More_footnotes dbt:Multiple_issues dbt:Primary_sources dbt:Reflist
has 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. (en)
prov:wasDerivedFrom	wikipedia-en:SDTM?oldid=1087620706&ns=0
page length (characters) of wiki page	13873 (xsd:nonNegativeInteger)
foaf:isPrimaryTopicOf	wikipedia-en:SDTM
is Link from a Wikipage to another Wikipage of	JANUS clinical trial data repository Clinical Data Interchange Standards Consortium Common data model Outline of clinical research Standard for Exchange of Non-clinical Data
is foaf:primaryTopic of	wikipedia-en:SDTM

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