Review ask

As a clinical trial statistician or programmer, challenge anything in this benchmark: describe a problem in Comments, or propose a fix with the Edit button on any source file.

  1. Task: Would a real study need this derivation, specified this way? Does it follow CDISC ADaM: variable names, controlled terms, record structure? Flag any rule that is ambiguous or that a sponsor would handle differently.
  2. Inputs: Do they look like data collected in a real trial, and do they include the situations you would expect to meet in one?
  3. Expected output: Would independent QC programming reproduce every value from these inputs and rules?

The other tabs beside Comments are background for assessment, not under review.

Summary

Lifecycle: draftEditUnder review
What this benchmark means
README.md

Goal: rank each subject's adverse events by severity, worst first.

Input: spec.yaml builds one record per row of input/ae.csv, which carries the subject, the event sequence number, the coded term, the reported severity, and the onset date.

Variables:

  • AEDECOD holds the coded adverse event term, copied from the source record.
  • AESEV holds the reported severity (MILD, MODERATE, or SEVERE), copied from the source record.
  • AESTDTC holds the event onset date, copied from the source record.
  • SEV_RANK is the event's severity rank within its subject: the worst severity ranks first, and the later onset date breaks a severity tie. Events tied on both share a rank, and the next rank is skipped.
  • SEV_SEQ counts the same ordering without gaps: events tied on every ordering rule take consecutive numbers in the order they appear in the source data.

Note: the ranking runs over each subject's records after every record's severity is scored MILD = 1, MODERATE = 2, SEVERE = 3, so the window reads the scored severity together with the stored subject and onset date; when two records tie on every ordering rule, the earlier source record comes first.

Inputs

Under review
1 source file

input/ae.csv

Edit
9 rows
input/ae.csv
STUDYIDUSUBJIDAESEQAEDECODAESEVAESTDTC
YAMAA-011HEADACHEMILD2024-01-02
YAMAA-012NAUSEASEVERE2024-01-05
YAMAA-013FATIGUEMODERATE2024-01-03
YAMAA-011HEADACHESEVERE2024-02-01
YAMAA-012NAUSEASEVERE2024-02-01
YAMAA-013FATIGUEMILD2024-02-02
YAMAA-011HEADACHEMODERATE2024-03-01
YAMAA-012NAUSEAMODERATE2024-03-05
YAMAA-013DIZZINESSSEVERE2024-03-01

Expected output

Under review
9 expected rows

expected/adae.csv

Edit
9 rows
expected/adae.csv
STUDYIDUSUBJIDAESEQAEDECODAESEVAESTDTCSEV_RANKSEV_SEQ
YAMAA-011HEADACHEMILD2024-01-0233
YAMAA-012NAUSEASEVERE2024-01-0511
YAMAA-013FATIGUEMODERATE2024-01-0322
YAMAA-011HEADACHESEVERE2024-02-0111
YAMAA-012NAUSEASEVERE2024-02-0112
YAMAA-013FATIGUEMILD2024-02-0233
YAMAA-011HEADACHEMODERATE2024-03-0133
YAMAA-012NAUSEAMODERATE2024-03-0522
YAMAA-013DIZZINESSSEVERE2024-03-0111
Shaded columns are derived— = missing value

Comments and assessment materials

Comments

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Mapping spec

Generated from the benchmark YAML; do not edit by hand

Dataset NameVariable NameVariable LabelTypeCodelist/Controlled TermsCoreComputational MethodOrigin
ADAESTUDYIDStudy IdentifiercharacterCopy value from AE.STUDYID.Predecessor
ADAEUSUBJIDUnique Subject IdentifiercharacterCopy value from AE.USUBJID.Predecessor
ADAEAESEQSequence NumbernumericCopy value from AE.AESEQ.Predecessor
ADAEAEDECODDictionary-Derived TermcharacterCopy value from AE.AEDECOD.Predecessor
ADAEAESEVSeverity/IntensitycharacterCopy value from AE.AESEV.Predecessor
ADAEAESTDTCStart Date/Time of Adverse EventcharacterCopy value from AE.AESTDTC.Predecessor
ADAESEV_RANKSeverity RanknumericTake SEV_RANK from the AE record matching on STUDYID, USUBJID and AESEQ, where SEV_RANK is derived as rank rows from 1 within each group of AE.USUBJID, ordered by SEVN descending then AE.AESTDTC descending; ties share a number and the next distinct value skips the gap, and a row with no match is an error.Derived
ADAESEV_SEQSeverity SequencenumericTake SEV_SEQ from the AE record matching on STUDYID, USUBJID and AESEQ, where SEV_SEQ is derived as row number within each group of AE.USUBJID, ordered by AE.SEVN descending then AE.AESTDTC descending, and a row with no match is an error.Derived
VersionDateAuthorDescriptionReviewerSign-off
1.32026-09-29yamaa docs buildShow study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata
1.22026-09-29yamaa docs buildClassify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived
1.12026-09-29yamaa docs buildResolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML
1.0yamaa docs buildInitial generation from spec.yaml

yamaa code

Runs the yamaa specification; its result must match the expected output

run.R

Edit
4 lines
library(yamaa)adae <- yamaa_domain("spec.yaml")$outputadae

run.py

Edit
4 lines
import yamaaadae = yamaa.yamaa_domain("spec.yaml").outputadae