sdtmchecks (version 1.0.0)

check_ec_sc_lat: Check if Study Drug is not administered in the Study Eye

Description

Check if Study Drug is not administered in the Study Eye. 1.> Subset Exposure dataset (EC) for only ocular Study Drug Administration records, and pass the check if there are none. If EC.ECCAT variable is available then remove records containing EC.ECCAT = “FELLOW”. If EC.ECCAT variable is not available then include all records, assuming drug administration is collected for study eye only. 2.> Subset Subject Characteristics dataset (SC) for only Study Eye Selection 3.> Compare Exposure dataset laterality (EC.ECLAT) with Subject Characteristics dataset laterality (SC.SCORRES - OS = LEFT, OD = RIGHT) and report if there is any mismatch.

Usage

check_ec_sc_lat(EC, SC)

Value

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

Arguments

EC

Subject Exposure Dataset with variables USUBJID, ECCAT (if available), ECLOC, ECMOOD, ECLAT, ECSTDY, VISIT, ECSTDTC, ECOCCUR, ECROUTE

SC

Subject Characteristics Dataset for Ophtha Study with variables USUBJID, SCTEST, SCTESTCD, SCCAT, SCORRES, SCDTC

Author

Monarch Shah (HackR 2021 Team Eye)

Examples

sc <- data.frame(USUBJID  = c(1,1,1,2,2,2),
                 SCTEST   = c("Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " ",
                              "Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " "),
                 SCTESTCD = c("ELIGEYE", "FOCID", "", "ELIGEYE", "FOCID", ""),
                 SCCAT    = c("STUDY EYE SELECTION", "STUDY EYE SELECTION", "",
                              "STUDY EYE SELECTION", "STUDY EYE SELECTION", ""),
                 SCORRES  = c("LEFT", "OS", "", "RIGHT", "OD", ""),
                 SCDTC    = "2021-01-01",
                 stringsAsFactors = FALSE)

ec <- data.frame(USUBJID = c(1,1,1,1,1,2,2,2,2,2,2),
                 ECCAT   = c("Fellow", "Study", "Study", "Study", "StudY",
                             "Fellow", "Fellow", "STUDY", "STUDY", "STUDY", ""),
                 ECMOOD  = rep("Performed", 11),
                 ECLOC   = rep("Eye", 11),
                 ECLAT   = c("LEFT", "Left", "left", "LEFT", "LEFT", "RIGHT",
                             "right", "right", "RIGHT", "RIGHT", "right"),
                 ECSTDY  = c(1, 28, 56, 84, 112, 1, 28, 56, 84, 112, 140),
                 VISIT   = c("Week 1", "Week 4", "Week 8", "Week 12", "Week 16",
                             "Week 1", "Week 4", "Week 8", "Week 12", "Week 16", "Week 20"),
                 ECSTDTC = c("2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-06-01"),
                 ECOCCUR = "Y",
                 ECROUTE = "INTRAVITREAL",
                 stringsAsFactors=FALSE)

check_ec_sc_lat(SC=sc, EC=ec)

sc <- data.frame(USUBJID  = c(1,1,1,2,2,2),
                 SCTEST   = c("Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " ",
                              "Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " "),
                 SCTESTCD = c("ELIGEYE", "FOCID", "", "ELIGEYE", "FOCID", ""),
                 SCCAT    = c("STUDY EYE SELECTION", "STUDY EYE SELECTION", "",
                              "STUDY EYE SELECTION", "STUDY EYE SELECTION", ""),
                 SCORRES  = c("LEFT", "OS", "", "RIGHT", "OD", ""),
                 SCDTC    = "2021-01-01",
                 stringsAsFactors = FALSE)

ec <- data.frame(USUBJID = c(1,1,1,1,1,2,2,2,2,2,2),
                 ECCAT   = c("Fellow", "Study", "Study", "Study", "StudY",
                             "Fellow", "Fellow", "STUDY", "STUDY", "STUDY", ""),
                 ECMOOD  = rep("Performed", 11),
                 ECLOC   = rep("Eye", 11),
                 ECLAT   = c("LEFT", "Left", "left", "LEFT", "RIGHT", "RIGHT",
                             "right", "right", "RIGHT", "RIGHT", "left"),
                 ECSTDY  = c(1, 28, 56, 84, 112, 1, 28, 56, 84, 112, 140),
                 VISIT   = c("Week 1", "Week 4", "Week 8", "Week 12", "Week 16",
                             "Week 1", "Week 4", "Week 8", "Week 12", "Week 16", "Week 20"),
                 ECSTDTC = c("2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-06-01"),
                 ECOCCUR = "Y",
                 ECROUTE = "OPHTHALMIC",
                 stringsAsFactors=FALSE)

check_ec_sc_lat(SC=sc, EC=ec)

sc <- data.frame(USUBJID  = c(1,1,1,2,2,2,3),
                 SCTEST   = c("Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " ",
                              "Eye Meeting Eligibility Criteria",
                              "Focus of Study-Specific Interest",
                              " ",
                              "Focus of Study-Specific Interest"),
                 SCTESTCD = c("ELIGEYE", "FOCID", "", "ELIGEYE", "FOCID", "", "FOCID"),
                 SCCAT    = c("STUDY EYE SELECTION", "STUDY EYE SELECTION", "",
                              "STUDY EYE SELECTION",
                              "STUDY EYE SELECTION", "", "STUDY EYE SELECTION"),
                 SCORRES  = c("LEFT", "OS", "", "RIGHT", "OD", "", "RIGHT"),
                 SCDTC    = "2021-01-01",
                 stringsAsFactors = FALSE)

ec <- data.frame(USUBJID = c(1,1,1,1,1,2,2,2,2,2,2),
                 ECMOOD  = "Performed",
                 ECLOC   = "Eye",
                 ECLAT   = c("LEFT", "Left", "left", "LEFT", "RIGHT", "RIGHT",
                             "right", "right", "RIGHT", "RIGHT", "left"),
                 ECSTDY  = c(1, 28, 56, 84, 112, 1, 28, 56, 84, 112, 140),
                 VISIT   = c("Week 1", "Week 4", "Week 8", "Week 12", "Week 16",
                             "Week 1", "Week 4", "Week 8", "Week 12", "Week 16", "Week 20"),
                 ECSTDTC = c("2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-01-01", "2021-02-01", "2021-03-01", "2021-04-01", "2021-05-01",
                             "2021-06-01"),
                 ECOCCUR = c("Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "N"),
                 stringsAsFactors=FALSE)

check_ec_sc_lat(SC=sc, EC=ec)