sdtmchecks (version 1.0.0)

check_ts_sstdtc_ds_consent: Check for missing SSTDTC (Study Start Date) in TS

Description

This check looks for missing SSTDTC (Study Start Date) in TS; if it's present, check that the date matches the earliest informed consent among any subject enrolled in the study. The FDA Technical Rejection Criteria for Study Data - effective September 15, 2021 requires Study Start Date (https://www.fda.gov/media/100743/download). If missing, no data queries are needed - this would be updating the assignment in the TS domain.

Usage

check_ts_sstdtc_ds_consent(DS, TS)

Value

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

Arguments

DS

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

TS

Trial Summary SDTM dataset with variables TSPARMCD, TSPARM, TSVAL

Author

Sara Bodach

Examples

TS1 <- data.frame(
 STUDYID = 1,
 TSPARMCD = "SSTDTC",
 TSPARM = "Study Start Date",
 TSVAL = "2017-01-01",
 TSVAL1 = "",
 TSVAL2 = ""
)

TS2 <- data.frame(
 STUDYID = 2,
 TSPARMCD = "AEDICT",
 TSPARM = "Study Start Date",
 TSVAL = "MedDRA v23.0",
 TSVAL1 = ""
)

TS3 <- data.frame(
 STUDYID = 3,
 TSPARMCD = "SSTDTC",
 TSPARM = "Study Start Date",
 TSVAL = ""
)

TS4 <- data.frame(
 STUDYID = 1,
 TSPARMCD = "SSTDTC",
 TSPARM = "Study Start Date",
 TSVAL = "2020-01-02",
 TSVAL1 = "",
 TSVAL2 = ""
)

TS5 = rbind(TS1, TS4)

TS6 <- data.frame(
 STUDYID = 1,
 TSPARMCD = "SSTDTC",
 TSPARM = "Study Start Date",
 TSVAL = "2020-01",
 TSVAL1 = "",
 TSVAL2 = ""
)

DS1 <- data.frame(
 USUBJID = c(1,1,2,3,4),
 DSCAT   = rep("PROTOCOL MILESTONE", 5),
 DSSCAT   = rep("PROTOCOL MILESTONE", 5),
 DSDECOD = c("INFORMED CONSENT OBTAINED", "OTHER", "PHYSICIAN DECISION",
             "OTHER", "INFORMED CONSENT OBTAINED"),
 DSSTDTC = c("2021-01-01", "2021-01-02", "2021-01-02", "2021-01-02", "2020-01-02"),
 stringsAsFactors = FALSE
)

check_ts_sstdtc_ds_consent(DS=DS1, TS=TS1)
check_ts_sstdtc_ds_consent(DS=DS1, TS=TS2)
check_ts_sstdtc_ds_consent(DS=DS1, TS=TS3)
check_ts_sstdtc_ds_consent(DS=DS1, TS=TS4)
check_ts_sstdtc_ds_consent(DS=DS1, TS=TS5)
check_ts_sstdtc_ds_consent(DS=DS1, TS=TS6)