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翻译 学习笔记_SDTM Domains _ Adverse Events (AE)
Adverse Events (AE)事件域,包含使用药品的患者或受试者中发生的不良医疗事件不良事件不一定与治疗有因果关系SpecificationVaribable NameDescriptionTypeNotesCoreSTUDYIDStudy IdentifierCharUnique identifier for a st
2022-03-29 10:05:15 928
转载 学习笔记_SDTM(3). Assumptions for Domain Models
文章目录1. General Domain Assumptions1. 1 Order of the Variables1.2 SDTM Core Designations1.3 Additional Guidance on Dataset Naming1.4 ==Splitting Domains==1.5 Origin Metadata1.5.1 Origin Metadata for Variables1.5.2 Origin Metadata for Records1.6 Assigning Nat
2022-02-16 14:52:09 632
转载 学习笔记_SDTM(2). Submitting Data in Standard Format
文章目录1.Standard Metadata for Dataset Contents and Attributes2. Dataset Metadata2.1 Primary Keys2.1.1 natural key2.1.2 surrogate key2.2 Value-level Metadata2.3 Conformance1.Standard Metadata for Dataset Contents and AttributesThe SDTMIG provides standard d
2022-02-16 11:04:14 173
转载 学习笔记_SDTM(1). Fundamentals of The SDTM
1. Observations and VariablesThe SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset.Variables can
2022-02-15 18:02:44 842 1
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