Create a reviewer's guide specification — guide

Holds the study-level fields of a Study Data Reviewer's Guide (SDRG) or Analysis Data Reviewer's Guide (ADRG) and an ordered list of sections. Sections are attached afterwards with add_section() / add_narrative(), and the whole guide is written to a file with render_guide().

guide_spec(
  study,
  type = c("sdrg", "adrg"),
  sponsor = NA_character_,
  protocol_title = NA_character_,
  standards_version = NA_character_,
  ...
)

Arguments

study: Study identifier (e.g. "CDISCPILOT01"). Required, non-empty.
type: Guide type: "sdrg" (Study Data Reviewer's Guide) or "adrg" (Analysis Data Reviewer's Guide).
sponsor: Sponsor name. Optional.
protocol_title: Protocol title. Optional.
standards_version: Standards version(s) followed, e.g. "SDTMIG 3.4". Optional.
...: Additional study-level fields, stored as-is in guide$meta.

Value

An object of class reviewerguider_guide: a list with elements meta and sections.

Examples

guide_spec(
  "CDISCPILOT01",
  type = "sdrg",
  sponsor = "Acme Pharma",
  protocol_title = "A Study of Drug X",
  standards_version = "SDTMIG 3.4"
)