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Metadataspec

Data Structure Name

Data Structure Descriptiona1

Class of Dataset

SubClass of Dataset

CDISC Notes1

ADSLSubject-Level Analysis DatasetSUBJECT LEVEL ANALYSIS DATASET
ADSL contains one record per subject, regardless of the type of clinical trial design. ADSL contains variables such as subject-level population flags, planned and actual treatment variables, demographic information, randomization factors, subgrouping variables, stratification factors, and important dates. ADSL is used to provide key facts about the subject that are analysis-enabling or which facilitate interpretation of analysis. The process for adding ADSL variables into BDS datasets is set by the producer of the datasets. 

1The Data Structure Description and CDISC Notes columns provide information to assist producers in preparing their datasets and are not intended to be metadata submitted in define.xml.