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changes.mady.by.user Darcy Wold

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changes.mady.by.user Alana St. Clair

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Metadataspec
aa of DatasetSubClass a contains one or is one or .

Data Structure Name

Data Structure Description

Class

of Dataset

CDISC Notes

BDSCDISC Basic Data StructureBASIC DATA STRUCTUREA BDS dataset contains 1 or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is conditionally required, depending on the analysis. In situations where there is no analysis timepoint, the structure is 1 or more records per subject per analysis parameter
TTEBasic Data Structure Time-to-EventBASIC DATA STRUCTURETIME-TO- EVENTDatasets in the SubClass TIME-TO-EVENT must have a Class of BASIC DATA STRUCTURE and meet all the principles of that class. A TTE dataset is used specifically for survival or time-to-event analyses and includes the following: (1) time from a defined starting point (e.g., the date of randomization or of an intervention) to the time of occurrence of the event of interest; and (2) an indication that a subject’s time to event has been censored and for what reason.
aThe Data Structure Name, Data Structure Description, and CDISC Notes columns are intended to provide information to assist producers in preparing their datasets and are not intended to be metadata submitted in define.xml
.