check_ae_aeout_aeendtc_aedthdtc: Check for AE outcome (AEOUT) of 'FATAL' with non-missing...

In sdtmchecks: Data Quality Checks for Study Data Tabulation Model (SDTM) Datasets

Check for AE outcome (AEOUT) of 'FATAL' with non-missing resolution date that is not equal to the death date

Description

This check looks for AEs with outcome of 'FATAL' but AE resolution date is not equal to AE death date. Note that these datapoints are not collected the same way for all trials - some trials leave AEENDTC missing if it was unresolved at death date. Confirm within your team before querying this issue.

Usage

check_ae_aeout_aeendtc_aedthdtc(AE, preproc = identity, ...)

Arguments

AE	Adverse Events SDTM dataset with variables USUBJID, AETERM, AEDTHDTC, AEENDTC, AEOUT
preproc	An optional company specific preprocessing script
...	Other arguments passed to methods

Value

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

Author(s)

Sara Bodach, Stella Banjo(HackR 2021)

Examples

AE <- data.frame(
    USUBJID = 1:10,
    DOMAIN = "AE",
    AEDTHDTC = c(NA, "NA", rep("2015-03-12",4), NA, NA, "2020-01-01", ""),
    AEENDTC = c(NA, "NA", rep("2015-03-12",4), NA, "2020-01-01", NA, ""),
    AEOUT = c("", "", "","FATAL","RECOVERED/RESOLVED", rep("FATAL",5)),
    AETERM = 1:10,
    AESPID = "FORMNAME-R:13/L:13XXXX",
    stringsAsFactors = FALSE
)

check_ae_aeout_aeendtc_aedthdtc(AE)
check_ae_aeout_aeendtc_aedthdtc(AE,preproc=roche_derive_rave_row)

AE$AESPID <- NULL
check_ae_aeout_aeendtc_aedthdtc(AE)

AE$AEDTHDTC <- NULL
AE$AEOUT <- NULL
check_ae_aeout_aeendtc_aedthdtc(AE)

sdtmchecks documentation built on Sept. 11, 2024, 9:34 p.m.