ATRI derived analysis dataset.
Usage
data(DS)
Details
SUBSTUDY: NA
BID: NA
DSSEQ: Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
DSDECOD: Modified Intent-to-Treat Flag, randomized subjects who have a baseline observation and at least one post-baseline observation = 1, others = 0
DSCAT: Used to define a category of related records. DSCAT is now an “Expected” variable. DSCAT was permissible in SDTMIG 3.1.1 and earlier versions. The change from “permissible” to “expected” is based on the requirement to distinguish protocol milestones and/or other events from disposition events. DSCAT may be null if there are only “disposition events”; however, it is recommended that DSCAT always be populated.
EPOCH: Epoch
DSSTDTC_DAYS_CONSENT: Disposition Start Date (Derived to days since study consent date)
DSSTDTC_DAYS_T0: Disposition Start Date (Derived to days since study start date [A4: Ranomization date | LEARN: Baseline registry exam date])
DSSTDY: Study day of start of event relative to the sponsor-defined RFSTDTC
Examples
if (FALSE) { # \dontrun{
browseVignettes('A4LEARN')
} # }