Check if Study Drug is not administered in the Study Eye

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.

check_ec_sc_lat(EC, SC)

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)
#> [1] TRUE

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)
#> [1] FALSE
#> attr(,"msg")
#> [1] "2 record(s) with Study Drug not administered in the Study Eye. "
#> attr(,"data")
#>   USUBJID      SCDTC SC_STUDYEYE ECCAT    ECROUTE ECLAT ECSTDY   VISIT
#> 1       1 2021-01-01        LEFT StudY OPHTHALMIC RIGHT    112 Week 16
#> 2       2 2021-01-01       RIGHT       OPHTHALMIC  left    140 Week 20
#>      ECSTDTC
#> 1 2021-05-01
#> 2 2021-06-01

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)
#> [1] FALSE
#> attr(,"msg")
#> [1] "EC is missing the variable: ECROUTE"