Check if randomized patients are missing stratification factor data

Check if Study is randomized (DS.DSDECOD == "RANDOMIZED" or "RANDOMIZATION"), and subject Characteristics Domain (SC) has no stratification factors reported.

check_ds_sc_strat(DS, SC)

Arguments

DS

Subject Dispostion Dataset with variable USUBJID, DSDECOD, DSSTDTC

SC

Subject Characteristics Dataset with variables USUBJID, SCTEST, SCTESTCD, SCCAT, SCORRES

Value

boolean value if check failed or passed with 'msg' attribute if the test failed

Author

Monarch Shah

Examples

ds <- data.frame(USUBJID = c(1,2,2),
                 DSDECOD = c("RANDOMIZATION", "RANDOMIZED", "Randomized"),
                 DSSTDTC = c("2021-01-01", "2021-01-02", "2021-02-01"))
sc <- data.frame(USUBJID  = c(1,1,1,2,2,2),
                 SCCAT = rep("STRATIFICATION", 6),
                 SCTESTCD = c("STRAT 1", "STRAT 2", "STRAT 3", "STRAT 1", "STRAT 2", "STRAT 3"),
                 SCTEST   = c("Factor 1", "Factor 2", "Factor 3",
                              "Factor 1", "Factor 2", "Factor 3"),
                 SCORRES  = c("US", "Left", "Score > x", "RoW", "Right", "Score < x"),
                 stringsAsFactors = FALSE)

check_ds_sc_strat(ds, sc)
#> [1] TRUE

ds <- data.frame(USUBJID = c(1,2,2),
                 DSDECOD = c("RANDOMIZATION", "RANDOMIZED", "Randomized"),
                 DSSTDTC = c("2021-01-01", "2021-01-02", "2021-02-01"))
sc <- data.frame(USUBJID  = c(1,1,1),
                 SCCAT = rep("STRATIFICATION", 3),
                 SCTESTCD = c("STRAT 1", "STRAT 2", "STRAT 3"),
                 SCTEST   = c("Factor 1", "Factor 2", "Factor 3"),
                 SCORRES  = c("US", "Left", NA),
                 stringsAsFactors = FALSE)

check_ds_sc_strat(ds, sc)
#> [1] FALSE
#> attr(,"msg")
#> [1] "2 patient(s) for randomized study where stratification factors are missing. "
#> attr(,"data")
#> # A tibble: 2 × 5
#> # Groups:   USUBJID [2]
#>   USUBJID DS_RANDDT  SCTESTCD  SCTEST     SCORRES
#>     <dbl> <date>     <chr>     <chr>      <chr>  
#> 1       1 2021-01-01 "STRAT 3" "Factor 3" " "    
#> 2       2 2021-01-02 " "       " "        " "    

ds <- data.frame(USUBJID = c(1,2),
                 DSDECOD = c("Open Label", "Open Label"),
                 DSSTDTC = c("2021-01-01", "2021-01-02"))
sc <- data.frame(USUBJID  = c(1,1,1,2,2,2),
                 SCCAT = rep("No STRATIFICATION", 6),
                 SCTESTCD = c("STRAT 1", "STRAT 2", "STRAT 3", "STRAT 1", "STRAT 2", "STRAT 3"),
                 SCTEST   = c("Factor 1", "Factor 2", "Factor 3",
                              "Factor 1", "Factor 2", "Factor 3"),
                 SCORRES  = c("US", "Left", NA, "RoW", "Right", "Score < x"),
                 stringsAsFactors = FALSE)

check_ds_sc_strat(ds, sc)
#> [1] FALSE
#> attr(,"msg")
#> [1] "Only applicable for randomized studies. Based on DS, no records were found indicating randomized patients."