Data Requirements designed based on pharmaversesdtm example datasets,
which are updated SDTM datasets that use data from the CDISC pilot project.
This has the same structure and attributes as results from
read_requirements and as_requirements.
Format
An object of class requirements (inherits from tbl_df, tbl, data.frame) with 54 rows and 5 columns.
Examples
head(dmcognigen_pk_requirements)
#> # A tibble: 6 × 5
#> variable_name variable_label pk_ard pk_mif format_decode
#> <chr> <chr> <chr> <chr> <chr>
#> 1 ONUM Overall Sequence Number x "x" ""
#> 2 NUM Sequence Number x "x" ""
#> 3 STUDYID Study Identifier x "" ""
#> 4 USUBJID Unique Subject Identifier x "" ""
#> 5 ID Subject ID x "x" ""
#> 6 TSFD Time Since First Dose (h) x "x" ""
as_decode_tbls(dmcognigen_pk_requirements)
#>
#> ── Decode tables ───────────────────────────────────────────────────────────────
#>
#> ── DVID ──
#>
#> 0=Dose
#> 1=Xanomeline Concentration (ug/mL)
#>
#> ── EVID ──
#>
#> 0=PK or PD measure
#> 1=Dose
#> 2=Other
#>
#> ── MDV ──
#>
#> 0=PK or PD measure
#> 1=Dose or Other
#>
#> ── BLQFN ──
#>
#> 0=No
#> 1=Yes
#>
#> ── FED ──
#>
#> 0=Fasted
#> 1=Fed
#>
#> ── RACEN ──
#>
#> 1=White/Caucasian
#> 2=Black/African American
#> 3=Asian
#> 4=American Indian or Alaska Native
#>
#> ── SEXF ──
#>
#> 0=Male
#> 1=Female
#>
#> ── RFCAT ──
#>
#> 1=Normal Function (>=90 mL/min)
#> 2=Mild Impairment (60-89 mL/min)
#> 3=Moderate Impairment (30-59 mL/min)
#> 4=Severe Impairment (15-29 mL/min)
#> 5=End Stage Disease (<15 mL/min or Dialysis)
#>
#> ── NCILIV ──
#>
#> 0=Normal Group A
#> 1=Mild Group B1
#> 2=Mild Group B2
#> 3=Moderate Group C
#> 4=Severe Group D