sdtmchecks (version 1.0.0)

check_ae_aeacnoth_ds_disctx: Check if, whenever a patient experiences an AE leading to study discontinuation, they also have a DS record indicating this.

Description

This code checks that when a patient has an AE with AEACNOTx = "SUBJECT DISCONTINUED FROM STUDY" (x = "H", "1", "2", ...) then there should also be a record in DS where DS.DSSCAT = "STUDY COMPLETION/EARLY DISCONTINUATION" and DS.DSDECOD != "COMPLETED".

Usage

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

Value

boolean value if check returns 0 obs, otherwise return subset dataframe.

Arguments

AE

Adverse Events SDTM dataset with variables USUBJID, AEDECOD, AEACNOTx

DS

Disposition SDTM dataset with variables USUBJID, DSCAT, DSSCAT, DSDECOD

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Author

Edoardo Mancini

Examples

AE <- data.frame(
    STUDYID  = "1001",
    USUBJID  = c("1","2","3","4","5","1"),
    AESTDTC  = rep('2020-05-05', 6),
    AEDECOD  = c("HEADACHE", "HEART ATTACK","CHILLS", "PNEUMONIA", "ARTHRITIS", "FATIGUE"),
    AEACNOTH = c("NONE", "SUBJECT DISCONTINUED FROM STUDY", "MULTIPLE", "NONE",
                 "SUBJECT DISCONTINUED FROM STUDY", "SUBJECT DISCONTINUED FROM STUDY"),
    AEACNOT1 = c("", "", "PROCEDURE/SURGERY", "", "", ""),
    AEACNOT2 = c("", "", "SUBJECT DISCONTINUED FROM STUDY", "", "", ""),
    AESPID = "FORMNAME-R:13/L:13XXXX",
    stringsAsFactors = FALSE
)

DS <- data.frame(
    USUBJID = c("1","5"),
    DSCAT   = c("DISPOSITION EVENT", "DISPOSITION EVENT"),
    DSSCAT  = c("STUDY COMPLETION/EARLY DISCONTINUATION", "STUDY COMPLETION/EARLY DISCONTINUATION"),
    DSDECOD = c("ADVERSE EVENT", "ADVERSE EVENT" ),
    stringsAsFactors = FALSE
)

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