sdtmchecks (version 1.0.0)

check_ds_sc_strat: Check if randomized patients are missing stratification factor data

Description

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

Usage

check_ds_sc_strat(DS, SC)

Value

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

Arguments

DS

Subject Dispostion Dataset with variable USUBJID, DSDECOD, DSSTDTC

SC

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

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)

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)

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)