Skip to contents

Document and apply a population flag

Source: R/population.R
lg_population.Rd

Population flags (SAFFL, ITTFL, PPROTFL, and custom flags) are first-class objects in lineager. Every flag must carry its inclusion criteria, exclusion criteria, and plain-English definition : the information needed to reconstruct the Reviewer's Guide population section automatically.

Usage

lg_population(
  data,
  flag_var,
  label,
  definition,
  incl_criteria,
  excl_criteria = NULL
)

Arguments

data

An lg_df containing the flag variable.

flag_var

Character. The flag variable name (e.g. "SAFFL").

label

Character. Human label (e.g. "Safety Analysis Flag").

definition

Character. Plain-English definition for regulatory reviewers (e.g. "All randomised subjects who received at least one dose of study medication").

incl_criteria

Character vector of inclusion criteria as R expressions or plain English. At least one required.

excl_criteria

Character vector of explicit exclusion criteria. NULL if there are none beyond failing inclusion.

Value

data, invisibly (for pipe use).

Details

The flag variable must already exist in data. lg_population() documents it; it does not compute it. Compute the flag first with lg_derive(), then call lg_population() to register its definition.

See also

lg_filter(), lg_disposition(), lg_report()

Examples

lg_start()
#> lineager: session started
adsl <- lg_tag(
  data.frame(USUBJID = c("01", "02", "03"),
             RANDFL  = c("Y","N","Y"), EXOCCUR = c("Y","N","Y"),
             SAFFL   = c("Y","N","Y")),
  dataset_id = "ADSL"
)
#> lineager: tagged 'ADSL' — 3 rows, 4 cols

lg_population(
  adsl,
  flag_var     = "SAFFL",
  label        = "Safety Analysis Flag",
  definition   = "All randomised subjects who received at least one dose",
  incl_criteria = c("RANDFL == 'Y'", "EXOCCUR == 'Y'"),
  excl_criteria = "No study drug administered (EXOCCUR != 'Y')"
)
#> lineager: population 'SAFFL' (Safety Analysis Flag) — 2 included, 1 excluded