R version 4.6.0 RC (2026-04-21 r89932 ucrt) -- "Because it was There" Copyright (C) 2026 The R Foundation for Statistical Computing Platform: x86_64-w64-mingw32/x64 R is free software and comes with ABSOLUTELY NO WARRANTY. You are welcome to redistribute it under certain conditions. Type 'license()' or 'licence()' for distribution details. R is a collaborative project with many contributors. Type 'contributors()' for more information and 'citation()' on how to cite R or R packages in publications. Type 'demo()' for some demos, 'help()' for on-line help, or 'help.start()' for an HTML browser interface to help. Type 'q()' to quit R. > # This file is part of the standard setup for testthat. > # It is recommended that you do not modify it. > # > # Where should you do additional test configuration? > # Learn more about the roles of various files in: > # * https://r-pkgs.org/testing-design.html#sec-tests-files-overview > # * https://testthat.r-lib.org/articles/special-files.html > > library(testthat) > library(rDataRecon) > > test_check("rDataRecon") --- SCENARIO 1: ADaM ADSL — Subject Level: Programmer vs Biostatistics Review --- [ADSL QC] 4 flag(s) changed — SAFFL/PPROTFL/DTHFL impact population counts! --- SCENARIO 2: ADaM ADAE — AE Analysis Dataset: Pre vs Post Medical Review --- *** SAE DEATH flag changed — regulatory notification may be required! *** --- SCENARIO 3: ADaM ADLB — Lab Analysis: Derivation QC (CHG, PCHG, Flags) --- --- SCENARIO 4: ADaM ADTTE — Time-to-Event: PFS Endpoint QC --- [ADTTE QC] Primary endpoint (PFS) changes: 4 — impact KM analysis! --- SCENARIO 5: ADaM BDS — QoL/PRO: Scoring Algorithm v1 vs v2 (SAP update) --- --- Side-by-side numeric summary (AVAL, CHG, PCHG) --- variable base_mean compare_mean base_sd compare_sd base_min compare_min 1 AVAL 24.256667 24.260667 34.406231 34.403160 0.72 0.731 2 CHG 1.350000 1.350333 3.768441 3.768315 -2.00 -2.000 3 PCHG -6.233333 -6.187778 26.756792 26.789898 -66.67 -66.670 base_max compare_max mean_diff 1 75.00 75.00 -0.0040000000 2 10.00 10.00 -0.0003333333 3 15.38 15.38 -0.0455555556 ======================================================================== ADAM SCENARIOS — SUMMARY ======================================================================== No. Domain Use Case Result ---- ------------ -------------------------------- ---------------------- 01 ADaM ADSL Programmer vs Biostatistics Review HAS DIFFERENCES (4 diff) 02 ADaM ADAE Pre vs Post Medical Review HAS DIFFERENCES (5 diff) 03 ADaM ADLB Derivation QC (CHG, PCHG, Flags) HAS DIFFERENCES (3 diff) 04 ADaM ADTTE Time-to-Event: PFS Endpoint QC HAS DIFFERENCES (4 diff) ======================================================================== Report written to: D:\temp\2026_04_22_12_55_17_2709\RtmpigINZk\fileef7c367b650f.txt ======================================================================== rDataRecon: SDTM & ADaM Dataset Comparison Scenarios CDISC-aligned | Submission-grade | FDA/EMA best practices ======================================================================== --- SCENARIO 1: SDTM DM — Demographics: Data Cut 1 vs Data Cut 2 --- Report written to: sdtm_dm_comparison.txt [QC RESULT] DM changes: 3 value difference(s) across 3 variable(s) --- SCENARIO 2: SDTM AE — Adverse Events: Sponsor vs CRO Reconciliation --- Report written to: sdtm_ae_comparison.txt *** CRITICAL: FATAL outcome discrepancy detected — expedited review required! *** obs_id variable base_value compare_value diff 3 USUBJID = STUDY001-003 | AESEQ = 1 AEOUT NOT RECOVERED FATAL --- SCENARIO 3: SDTM LB — Lab Data: Central Lab Extract vs SDTM Mapped --- --- SCENARIO 4: SDTM CM — Conmed: eCRF vs WHODrug Coded Dataset --- --- SCENARIO 5: SDTM VS — Vital Signs: Baseline vs Week 24 Derivation QC --- --- SCENARIO 6: SDTM EX — Exposure: Planned vs Actual Dose --- Report written to: sdtm_ex_comparison.txt [EX QC] 4 protocol deviation(s) detected in exposure data --- SCENARIO 7: SDTM MH — Medical History: eCRF vs MedDRA Coded --- --- SCENARIO 8: SDTM DS — Disposition: Interim vs Final Cut --- *** DEATH disposition flag changed — regulatory safety review required *** --- SCENARIO 9: SDTM SV — Subject Visits: Scheduled vs Actual Dates --- --- SCENARIO 9: SDTM TU — Tumour ID: Investigator vs Central Read --- [TU QC] 6 tumour classification differences — impacts RECIST 1.1 response --- SCENARIO 11: SDTM TR — Tumour Results: Measurement QC (1mm tolerance) --- -- With 1mm absolute tolerance for measurement precision -- --- SCENARIO 12: SDTM RS — Response: Investigator vs BICR Assessment --- [RS QC] 5 response upgraded to PD by BICR — recalculate PFS! --- SCENARIO 13: SDTM EG — ECG: Central Lab vs Site ECG Values --- -- With 5ms tolerance for ECG measurement precision -- *** QTcF > 450ms flagged by central lab — safety review required! *** --- SCENARIO 14: SDTM PE — Physical Exam: Site vs Medical Monitor Review --- --- SCENARIO 15: SDTM QS — Questionnaire: Paper CRF vs eDiary --- -- Zero tolerance: every integer difference is a transcription error -- [QS QC] 6 PRO transcription errors detected — source data verification required --- SCENARIO 16: SDTM DM — Demographics: Race/Ethnicity Coding QC --- --- SCENARIO 17: SDTM LB — Urinalysis & Coagulation: Reference Range QC --- --- SCENARIO 18: SDTM AE — SAE Flags: Safety Database vs SDTM --- *** AESDTH=Y added — expedited 7/15-day safety report required *** --- SCENARIO 19: SDTM SU — Substance Use: eCRF vs IRT System --- --- SCENARIO 20: SDTM RELREC — Related Records: AE-CM Linkage QC --- ======================================================================== SDTM SCENARIOS — SUMMARY ======================================================================== No. Domain Use Case Result ---- ------------ -------------------------------- ---------------------- 01 SDTM DM Data Cut 1 vs Data Cut 2 HAS DIFFERENCES (3 diff) 02 SDTM AE Sponsor vs CRO Reconciliation HAS DIFFERENCES (3 diff) 03 SDTM LB Central Lab Extract vs SDTM Mapped HAS DIFFERENCES (4 diff) 04 SDTM CM eCRF vs WHODrug Coded Dataset HAS DIFFERENCES (3 diff) 05 SDTM CM Baseline vs Week 24 Derivation QC HAS DIFFERENCES (10 diff) 06 SDTM EX Planned vs actual dose HAS DIFFERENCES (4 diff) 07 SDTM MH eCRF vs MedDRA coded HAS DIFFERENCES (7 diff) 09 SDTM DS Interim vs final cut HAS DIFFERENCES (6 diff) 10 SDTM SV Scheduled vs actual visits HAS DIFFERENCES (6 diff) 11 SDTM TU Investigator vs central read HAS DIFFERENCES (6 diff) 12 SDTM TR Tumour measurement QC (1mm) HAS DIFFERENCES (6 diff) 13 SDTM RS Investigator vs BICR HAS DIFFERENCES (7 diff) 14 SDTM EG Site vs central ECG (5ms) HAS DIFFERENCES (5 diff) 15 SDTM PE Site vs medical monitor HAS DIFFERENCES (6 diff) 16 SDTM QS Paper CRF vs eDiary HAS DIFFERENCES (6 diff) 17 SDTM DM Race/ethnicity coding QC HAS DIFFERENCES (2 diff) 18 SDTM LB Urinalysis & coagulation HAS DIFFERENCES (6 diff) 19 SDTM AE SAE flags reconciliation HAS DIFFERENCES (3 diff) 20 SDTM SU eCRF vs IRT system HAS DIFFERENCES (5 diff) 21 SDTM RELREC AE-CM linkage QC HAS DIFFERENCES (10 diff) ======================================================================== [ FAIL 0 | WARN 0 | SKIP 2 | PASS 47 ] ══ Skipped tests (2) ═══════════════════════════════════════════════════════════ • empty test (2): , [ FAIL 0 | WARN 0 | SKIP 2 | PASS 47 ] > > proc.time() user system elapsed 2.18 0.31 2.53