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.
- 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.
- Inputs: Do they look like data collected in a real trial, and do they include the situations you would expect to meet in one?
- 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
README.mdGoal: 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:
AEDECODholds the coded adverse event term, copied from the source record.AESEVholds the reported severity (MILD, MODERATE, or SEVERE), copied from the source record.AESTDTCholds the event onset date, copied from the source record.SEV_RANKis 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_SEQcounts 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 review1 source fileinput/ae.csv
Edit9 rows| STUDYID | USUBJID | AESEQ | AEDECOD | AESEV | AESTDTC |
|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | MILD | 2024-01-02 | |
| YAMAA-01 | 2 | NAUSEA | SEVERE | 2024-01-05 | |
| YAMAA-01 | 3 | FATIGUE | MODERATE | 2024-01-03 | |
| YAMAA-01 | 1 | HEADACHE | SEVERE | 2024-02-01 | |
| YAMAA-01 | 2 | NAUSEA | SEVERE | 2024-02-01 | |
| YAMAA-01 | 3 | FATIGUE | MILD | 2024-02-02 | |
| YAMAA-01 | 1 | HEADACHE | MODERATE | 2024-03-01 | |
| YAMAA-01 | 2 | NAUSEA | MODERATE | 2024-03-05 | |
| YAMAA-01 | 3 | DIZZINESS | SEVERE | 2024-03-01 |
Expected output
Under review9 expected rowsexpected/adae.csv
Edit9 rows| STUDYID | USUBJID | AESEQ | AEDECOD | AESEV | AESTDTC | SEV_RANK | SEV_SEQ |
|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | MILD | 2024-01-02 | 3 | 3 | |
| YAMAA-01 | 2 | NAUSEA | SEVERE | 2024-01-05 | 1 | 1 | |
| YAMAA-01 | 3 | FATIGUE | MODERATE | 2024-01-03 | 2 | 2 | |
| YAMAA-01 | 1 | HEADACHE | SEVERE | 2024-02-01 | 1 | 1 | |
| YAMAA-01 | 2 | NAUSEA | SEVERE | 2024-02-01 | 1 | 2 | |
| YAMAA-01 | 3 | FATIGUE | MILD | 2024-02-02 | 3 | 3 | |
| YAMAA-01 | 1 | HEADACHE | MODERATE | 2024-03-01 | 3 | 3 | |
| YAMAA-01 | 2 | NAUSEA | MODERATE | 2024-03-05 | 2 | 2 | |
| YAMAA-01 | 3 | DIZZINESS | SEVERE | 2024-03-01 | 1 | 1 |
Comments and assessment materials
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Copy value from AE.STUDYID. | Predecessor | ||
| ADAE | USUBJID | Unique Subject Identifier | character | Copy value from AE.USUBJID. | Predecessor | ||
| ADAE | AESEQ | Sequence Number | numeric | Copy value from AE.AESEQ. | Predecessor | ||
| ADAE | AEDECOD | Dictionary-Derived Term | character | Copy value from AE.AEDECOD. | Predecessor | ||
| ADAE | AESEV | Severity/Intensity | character | Copy value from AE.AESEV. | Predecessor | ||
| ADAE | AESTDTC | Start Date/Time of Adverse Event | character | Copy value from AE.AESTDTC. | Predecessor | ||
| ADAE | SEV_RANK | Severity Rank | numeric | Take 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 | ||
| ADAE | SEV_SEQ | Severity Sequence | numeric | Take 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 |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 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 |
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Comments
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