Bundled example SDTM inputs

Two fixture sets ship with the package so that every example, test and vignette chunk runs offline, with no data package.

sdtmgap_example(name = NULL)

Source

CDISCPILOT01 SDTM, CDISC Data Exchange Standards Team, distributed with the CDISC SDTM/ADaM pilot project submission package.

Arguments

name: Dataset name, one of the values returned by sdtmgap_example(). NULL (default) returns the available names.

Value

A tibble, or a character vector of names when name is NULL. Everything is character except the numeric SDTM variables (VISITNUM, VISITDY, TAETORD, AGE, --SEQ, --DOSE, --STRESN).

`lzzt_*` — the real study

CDISCPILOT01 (the "LZZT" Alzheimer's study), the CDISC SDTM/ADaM pilot submission package, coded to SDTMIG 3.1.2 (def:StandardVersion="3.1.2" in its own define.xml) and published by the CDISC Data Exchange Standards Team. These are the study's real datasets, read from the SAS transport files and written out unchanged apart from two things: lzzt_dm and lzzt_ex keep only the columns the vignette uses, and text was transcoded from Windows-1252 to ASCII (a few curly apostrophes in lzzt_ts).

Name	Rows	What it is
`lzzt_te`	7	Trial Elements
`lzzt_ta`	8	Trial Arms
`lzzt_tv`	21	Trial Visits
`lzzt_ti`	31	Trial Inclusion/Exclusion Criteria
`lzzt_ts`	33	Trial Summary
`lzzt_dm`	306	Demographics (15 of 25 columns)
`lzzt_ex`	591	Exposure (12 of 17 columns), no `ETCD`
`lzzt_se`	752	Subject Elements, the study's own — the comparison target
`lzzt_sv`	3559	Subject Visits, the study's own

lzzt_tv, lzzt_ti and lzzt_ts are bundled so the trial design is complete and inspectable. No function in sdtmgap reads them — visit windowing from TV in particular is not implemented.

`edge_*` — the edge-case fixture

A fictional 7-subject study (SDTMGAP01) that exists only to hold the awkward cases CDISCPILOT01 does not have, so they can be tested at all: an element with no recorded end date, a subject with no follow-up element, a screen failure with no elements, partial "2026-01" and "2026-02" dates, a visit landing exactly on a shared element boundary, and a record dated before the study began. It is not a demonstration of the package on real data — the lzzt_* set is. Available as edge_dm, edge_te, edge_ta, edge_elements, edge_vs, edge_lb.

Examples

sdtmgap_example()
#>  [1] "edge_dm"       "edge_elements" "edge_lb"       "edge_ta"      
#>  [5] "edge_te"       "edge_vs"       "lzzt_dm"       "lzzt_ex"      
#>  [9] "lzzt_se"       "lzzt_sv"       "lzzt_ta"       "lzzt_te"      
#> [13] "lzzt_ti"       "lzzt_ts"       "lzzt_tv"      
sdtmgap_example("lzzt_te")
#> # A tibble: 7 × 7
#>   STUDYID      DOMAIN ETCD  ELEMENT     TESTRL                      TEENRL TEDUR
#>   <chr>        <chr>  <chr> <chr>       <chr>                       <chr>  <chr>
#> 1 CDISCPILOT01 TE     FOLO  Follow_up   End of last scheduled visi… Compl… NA   
#> 2 CDISCPILOT01 TE     HIE   High_End    Administration of first do… NA     P2W  
#> 3 CDISCPILOT01 TE     HIM   High_Middle Administration of first do… NA     P22W 
#> 4 CDISCPILOT01 TE     HIS   High_Start  Administration of first do… NA     P2W  
#> 5 CDISCPILOT01 TE     LO    Low         Administration of first do… NA     P26W 
#> 6 CDISCPILOT01 TE     PBO   Placebo     Administration of first do… NA     P26W 
#> 7 CDISCPILOT01 TE     SCRN  Screen      Informed consent            Compl… NA   
sdtmgap_example("edge_te")
#> # A tibble: 4 × 7
#>   STUDYID   DOMAIN ETCD  ELEMENT                TESTRL              TEENRL TEDUR
#>   <chr>     <chr>  <chr> <chr>                  <chr>               <chr>  <chr>
#> 1 SDTMGAP01 TE     SCRN  Screening              Informed consent    First… P14D 
#> 2 SDTMGAP01 TE     TRTA  Drug A 10 mg Treatment First dose of Drug… Last … P28D 
#> 3 SDTMGAP01 TE     TRTB  Placebo Treatment      First dose of plac… Last … P28D 
#> 4 SDTMGAP01 TE     FUP   Follow-up              Day after last dose End o… P14D