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A realistic evidence table for study CDISCPILOT01 (Clinical Data Interchange Standards Consortium Pilot Study 01) covering all four R4SUB (R for Regulatory Submission) pillars (quality, trace, risk, usability) with 250 rows and 18 indicators across multiple datasets and sources.

Usage

evidence_pharma

Format

A tibble with 250 rows and 17 columns:

run_id

Character. Unique run identifier.

study_id

Character. Study identifier (CDISCPILOT01).

asset_type

Character. Asset type: dataset, define, program, validation, spec, other.

asset_id

Character. Asset identifier (e.g., ADSL, define.xml).

source_name

Character. Source of the evidence (e.g., pinnacle21).

source_version

Character. Version of the source tool.

indicator_id

Character. Indicator identifier (e.g., Q-MISS-VAR).

indicator_name

Character. Human-readable indicator name.

indicator_domain

Character. Domain: quality, trace, risk, usability.

severity

Character. Severity: info, low, medium, high, critical.

result

Character. Result: pass, fail, warn, na.

metric_value

Numeric. Metric value (if applicable).

metric_unit

Character. Unit for metric_value.

message

Character. Descriptive message.

location

Character. Location reference (e.g., ADSL:AGE).

evidence_payload

Character. JSON payload with additional details.

created_at

POSIXct. Timestamp when evidence was created.

Source

Synthetic data based on the CDISC (Clinical Data Interchange Standards Consortium) Pilot Study 01 structure.

Examples

data(evidence_pharma)
head(evidence_pharma)
#> # A tibble: 6 × 17
#>   run_id    study_id asset_type asset_id source_name source_version indicator_id
#>   <chr>     <chr>    <chr>      <chr>    <chr>       <chr>          <chr>       
#> 1 R4S-2025… CDISCPI… dataset    ADSL     pinnacle21  1.0.0          Q-VALUE-RAN…
#> 2 R4S-2025… CDISCPI… dataset    ADCM     pinnacle21  1.0.0          R-MITIGATIO…
#> 3 R4S-2025… CDISCPI… dataset    ADLB     manual_rev… 1.0.0          Q-TYPE-MISM…
#> 4 R4S-2025… CDISCPI… dataset    ADCM     manual_rev… 1.0.0          Q-REF-INTEG…
#> 5 R4S-2025… CDISCPI… dataset    ADCM     r4subrisk   1.0.0          Q-CT-COMPLI…
#> 6 R4S-2025… CDISCPI… dataset    LB       define_che… 1.0.0          T-ORPHAN-VAR
#> # ℹ 10 more variables: indicator_name <chr>, indicator_domain <chr>,
#> #   severity <chr>, result <chr>, metric_value <dbl>, metric_unit <chr>,
#> #   message <chr>, location <chr>, evidence_payload <chr>, created_at <dttm>
table(evidence_pharma$indicator_domain)
#> 
#>   quality      risk     trace usability 
#>       120        39        47        44