出典:Wikipedia
出典:『Wikipedia』 (2010/03/11 14:05 UTC 版)
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (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.