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Export Trial Data to CDISC SDTM-Shaped Domains

Source: R/cdisc.R
toSDTM.Rd

Builds deterministic, linked trial domains with explicit sponsor mappings. The output is structurally SDTM-shaped; it is not a claim of CDISC, regulator, or third-party validator conformance.

Usage

toSDTM(
  trial,
  participants,
  adverse_events = NULL,
  findings = list(),
  study_id = trial@id,
  id_col = "id",
  arm_col = "arm",
  sex_col = NULL,
  birth_date_col = NULL,
  reference_start_col = NULL,
  reference_end_col = NULL,
  country_col = NULL,
  site_col = NULL,
  extra_domains = list()
)

Arguments

trial

A Trial object.

participants

One row per screened or enrolled participant.

adverse_events

Optional adverse events accepted by aeSummary().

findings

Named list containing normalized VS, EG, or XP findings data frames.

study_id

Non-empty study identifier.

id_col, arm_col

Participant ID and assigned-arm columns.

sex_col, birth_date_col, reference_start_col, reference_end_col

Optional participant columns.

country_col, site_col

Optional country and site columns.

extra_domains

Named list of already constructed two-letter domains, such as output from PhysioClinical::toCDISC_QS().

Value

An sdtm_export containing datasets, manifest, and mapping metadata.

Examples

trial <- Trial("T1", c("active", "control"))
participants <- data.frame(
  id = c("p1", "p2"),
  arm = c("active", "control")
)
export <- toSDTM(trial, participants)
export$datasets$DM
#>   STUDYID DOMAIN USUBJID SUBJID SITEID RFSTDTC RFENDTC BRTHDTC  SEX COUNTRY
#> 1      T1     DM   T1-p1     p1   <NA>    <NA>    <NA>    <NA> <NA>    <NA>
#> 2      T1     DM   T1-p2     p2   <NA>    <NA>    <NA>    <NA> <NA>    <NA>
#>   ARMCD     ARM
#> 1  ARM1  active
#> 2  ARM2 control