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Summary
EditUnder reviewWhat this benchmark meansREADME.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build STRAT1R from the values recorded at
randomization and STRAT1 from the matching values collected
independently at entry, and require the two combined values to
agree.
Input: demographics entries, disease-history entries, and the strata recorded at randomization, linked by the study and subject identifiers shared across the three files.
Variables:
METSTATR: metastatic disease status recorded at randomization, copied from inputMETSTATin the randomization file.ECOG0R: baseline performance status on the Eastern Cooperative Oncology Group (ECOG) scale recorded at randomization, copied from inputECOG0in the randomization file.REGIONUSR: region recorded at randomization, copied from inputREGIONUSin the randomization file.METSTAT: metastatic disease status from the disease-history entries, copied from inputMETSTATthere.ECOG0: baseline ECOG performance status from the demographics entries, copied from inputECOG0there.REGIONUS: region from the demographics entries, copied from inputREGIONUSthere.STRAT1R: combined randomization strata, joiningMETSTATR,ECOG0R, andREGIONUSRwith|.STRAT1: combined independently collected strata, joiningMETSTAT,ECOG0, andREGIONUSwith|in the same order.
The two combined values must agree for every subject; a single disagreement rejects the run, and no artifact is accepted.
Note: the expected file records the completed rows as presented to the check; the disagreement still rejects the run.
How to fix
Query the disagreement and correct whichever source is wrong. If both values are valid but serve different purposes, document which one governs the analysis and replace the equality check with that reconciliation policy. Do not silently prefer the randomization value or the independently collected value.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- verification
- condition
- assert_failed
- rule
- CHECK-12
expected/error.yaml
phase: verification
condition: assert_failed
spec_paths:
- verifications[1].assert
rule: CHECK-12
context:
verification_id: randomized-strata-agree
failure_count: 1
keys:
- STUDYID: PILOT7
USUBJID: P7-103
Inputs
Under review3 source filesUnexpected Output
Under review3 rows presented to the failing check - not an accepted artifactexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | METSTATR | ECOG0R | REGIONUSR | METSTAT | ECOG0 | REGIONUS | STRAT1R | STRAT1 |
|---|---|---|---|---|---|---|---|---|---|
| PILOT7 | M0 | Y | US | M0 | Y | US | M0|Y|US | M0|Y|US | |
| PILOT7 | M1 NED | N | NON-US | M1 NED | N | NON-US | M1 NED|N|NON-US | M1 NED|N|NON-US | |
| PILOT7 | M1 NED | Y | US | M0 | Y | US | M1 NED|Y|US | M0|Y|US |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | METSTATR | Randomization Metastatic Disease Status | character | Copy value from RE.METSTAT. | Predecessor | ||
| ADSL | ECOG0R | Randomization Baseline ECOG Performance Status | character | Copy value from RE.ECOG0. | Predecessor | ||
| ADSL | REGIONUSR | Randomization United States Region | character | Copy value from RE.REGIONUS. | Predecessor | ||
| ADSL | METSTAT | Metastatic Disease Status | character | Copy value from MH.METSTAT. | Predecessor | ||
| ADSL | ECOG0 | Baseline ECOG Performance Status | character | Copy value from DM.ECOG0. | Predecessor | ||
| ADSL | REGIONUS | United States Region | character | Copy value from DM.REGIONUS. | Predecessor | ||
| ADSL | STRAT1R | Randomization Stratification Factor 1 | character | Fill the template "{METSTATR}|{ECOG0R}|{REGIONUSR}". | Derived | ||
| ADSL | STRAT1 | Analysis Stratification Factor 1 | character | Fill the template "{METSTAT}|{ECOG0}|{REGIONUS}". | Derived |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 1.7 | 2026-10-20 | yamaa docs build | Read a specification in the 1.0 surface as its 0.5 counterpart; state that missing values stay missing where a mapping declares no missing handler, and leave out a declared missing answer that restates a handler's default | ||
| 1.6 | 2026-10-17 | yamaa docs build | Describe collected date parts written as ISO 8601 date text and times of day counted in seconds since midnight | ||
| 1.5 | 2026-10-17 | yamaa docs build | Name collected precision in words instead of letter codes; state imputation fallbacks, minimum source precision, bounds ignored outside the collected period, and invalid text with no handler as an error; describe date and datetime shifts, imputation flag codes, and partial text giving no date part | ||
| 1.4 | 2026-10-15 | yamaa docs build | State datetime precision codes through the hour and minute, and complete only the time parts a collected datetime lacks | ||
| 1.3 | 2026-09-29 | yamaa docs build | Show study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata | ||
| 1.2 | 2026-09-29 | yamaa docs build | Classify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived | ||
| 1.1 | 2026-09-29 | yamaa docs build | Resolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML | ||
| 1.0 | yamaa docs build | Initial generation from spec.yaml |