check_ae_death_ds_discon: Check if death in AE then there should be a study discon form

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

Check if death in AE then there should be a study discon form

Description

This checks that if death is indicated in AE via AEDTHDTC/AESDTH/AEOUT (as well as grade 5 AE if AETOXGR exists) then there should be a study discontinuation record indicated by DS.DSSCAT

Usage

check_ae_death_ds_discon(AE, DS, preproc = identity, ...)

Arguments

AE	Adverse Events SDTM dataset with variables USUBJID, AEDTHDTC, AESDTH, AEOUT
DS	Disposition SDTM dataset with variables USUBJID, DSCAT, DSSCAT
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

Examples

AE <- data.frame(
 STUDYID = rep(1,6),
 USUBJID = 1:6,
 AEDTHDTC = c(NA,"2020-01-01",NA,NA,NA,NA),
 AESDTH = c(NA,NA,"Y",NA,NA,NA),
 AEOUT = c(NA,NA,NA,"FATAL",NA,NA),
 AETOXGR = c(NA,NA,NA,NA,"5",NA),
 AESPID="FORMNAME-R:2/L:2XXXX"
)

DS <- data.frame(
 STUDYID = 1,
 USUBJID = 1:3,
 DSCAT="DISPOSITION EVENT",
 DSSCAT=c("STUDY DISCON",
 "STUDY DISCON",
 "STUDY COMPLETION/EARLY DISCONTINUATION")
)

check_ae_death_ds_discon(AE,DS)
check_ae_death_ds_discon(AE,DS,preproc=roche_derive_rave_row)

DS$DSSCAT = NULL

check_ae_death_ds_discon(AE,DS)

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