Check for Invalid EXDOSE (Dose per Administration) and Missing/Incomplete EXSTDTC (Start Date) Values for valid exposures

This check looks for valid exposures (EXOCCUR=Y or doesn't exist) but EXDOSE (dose per administration) is not > 0 (>= 0 in case of placebo) and/or EXSTDTC (start date/treatment date) is missing or incomplete in the EX (exposure) SDTM domain

check_ex_exoccur_exdose_exstdtc(EX)

Arguments

EX

Exposure SDTM dataset with variables USUBJID, VISIT, VISITNUM, EXOCCUR, EXTRT, EXDOSE, EXSTDTC and EXENDTC

Value

Boolean value for whether the check passed or failed, with 'msg' attribute if the check failed

Author

Sara Bodach

Examples

EX <- data.frame(USUBJID = LETTERS[1:5],
                 VISIT = paste0("Visit ", 1:5),
                 VISITNUM = 1:5,
                 EXOCCUR = c('Y', rep('', 4)),
                 EXTRT = LETTERS[1:5],
                 EXDOSE = 1:5,
                 EXSTDTC = c('2010-01-01', rep('', 4)),
                 EXENDTC = c('2010-01-01', rep('', 4)),
                 stringsAsFactors = FALSE)

EX$EXOCCUR[2] <- 'Y'
EX$EXSTDTC[2] <- '2011'
EX$EXDOSE[1] <- 0

check_ex_exoccur_exdose_exstdtc(EX)
#> [1] FALSE
#> attr(,"msg")
#> [1] "There are 2 EX records with invalid dosing amount or missing full treatment administration date. "
#> attr(,"data")
#>   USUBJID   VISIT VISITNUM EXOCCUR EXTRT EXDOSE    EXSTDTC    EXENDTC
#> 1       A Visit 1        1       Y     A      0 2010-01-01 2010-01-01
#> 2       B Visit 2        2       Y     B      2       2011           

EX$VISIT <- NULL

check_ex_exoccur_exdose_exstdtc(EX)
#> [1] FALSE
#> attr(,"msg")
#> [1] "EX is missing the variable: VISIT"