本文介绍SDTM-FA(Findings about) domain的常见Map实例。 SDTM数据中,大约80%的观测可归纳为这样3种general observation classes:Interventions,Events, 或Findings,但有一些数据不是直接来源于某个指定的标准domain,也不能归类到supplemental数据集。鉴于此,面对不合适或...
INTRODUCTIONSDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial data tabulations and SEND (for nonclinical study data tabulations) that are to be submitted as part of a product application to a regulatory authority such as FDA. Observations about subjects are ...