Exposure-response and population PK analysis datasets have no CDISC standard structure, so every study invents one. This function returns the structure this package commits to, as data, so it can be dropped into a define document, a data specification or a review of the delivered datasets.

eradam_structure(dataset = NULL)

Arguments

dataset

Optional dataset name: one of "exposure", "terminal", "partial", "adpc", "poppk" or "ader". NULL (the default) returns all six.

Value

A tibble::tibble with one row per variable and columns dataset, variable, label and source.

Details

The same table is rendered into the help page of each producing function, so the documentation and the code cannot drift apart.

Examples

eradam_structure("poppk")
#> # A tibble: 13 × 4
#>    dataset variable     label                                             source
#>    <chr>   <chr>        <chr>                                             <chr> 
#>  1 poppk   ID           Sequential integer subject identifier (1..n), th… Deriv…
#>  2 poppk   USUBJID      Unique subject identifier, retained for traceabi… `pc` …
#>  3 poppk   TIME         Actual time from first dose (h)                   `pc$A…
#>  4 poppk   NTIM         Nominal time from first dose (h)                  `pc$N…
#>  5 poppk   TAD          Actual time after the most recent dose (h)        Deriv…
#>  6 poppk   AMT          Dose amount on dosing records, `NA` on observati… `ex`  
#>  7 poppk   DV           Dependent variable (observed concentration); `NA… `pc`  
#>  8 poppk   MDV          Missing dependent variable flag: 1 when DV is mi… Deriv…
#>  9 poppk   EVID         Event identifier: 1 = dosing record, 0 = observa… Deriv…
#> 10 poppk   CMT          Compartment: 1 = dosing, 2.. = one per analyte i… Deriv…
#> 11 poppk   BLQ          1 when the observation was below the limit of qu… Deriv…
#> 12 poppk   PARAMCD      Analyte code for observation records, `NA` for d… `pc`  
#> 13 poppk   <covariates> Subject-level covariates carried from ADSL        `adsl…

# every variable this package can produce
eradam_structure()
#> # A tibble: 82 × 4
#>    dataset  variable label                                                source
#>    <chr>    <chr>    <chr>                                                <chr> 
#>  1 exposure USUBJID  Unique subject identifier                            `pc` …
#>  2 exposure PARAMCD  Analyte code                                         `pc` …
#>  3 exposure NOBS     Number of quantifiable observations used             Deriv…
#>  4 exposure TFIRST   Time of the first quantifiable concentration         Deriv…
#>  5 exposure TLAST    Time of the last quantifiable concentration          Deriv…
#>  6 exposure CMAX     Maximum observed concentration                       Deriv…
#>  7 exposure TMAX     Time of the maximum observed concentration (first i… Deriv…
#>  8 exposure CMIN     Minimum observed quantifiable concentration          Deriv…
#>  9 exposure CTROUGH  Concentration at the last observation time in the p… Deriv…
#> 10 exposure AUCLST   Area under the curve from the first to the last qua… Deriv…
#> # ℹ 72 more rows