yamaa 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
EditUnder reviewWhat this benchmark meansREADME.mdGoal: flag adverse events whose dictionary-derived term contains
one of the dermatologic criterion terms (APPLICATION,
DERMATITIS, ERYTHEMA, or BLISTER), the kind of term search
behind a customized query name such as CQ01NAM.
Input: one record per adverse event carrying AESEQ (sequence
number) and AEDECOD (dictionary-derived term).
Variables:
CRIT1FL:Ywhen the term contains any of the four criterion terms anywhere in its text, asAPPLICATION SITE DERMATITISdoes; missing otherwise.DERMFL:Ywhen the term containsDERM(as inDERMATITIS) orERYTHEMAanywhere in its text; missing otherwise.
Note: each flag is Y or blank, never N. An event with no
recorded term is blank as well: its search is unknown rather than a
non-match, and only a match sets the flag.
Inputs
Under review1 source fileinput/ae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AEDECOD |
|---|---|---|---|
| CATH-01 | 1 | HEADACHE | |
| CATH-01 | 2 | APPLICATION SITE DERMATITIS | |
| CATH-01 | 3 | NAUSEA | |
| CATH-01 | 4 | ERYTHEMA | |
| CATH-01 | 1 | BLISTER | |
| CATH-01 | 2 | VOMITING | |
| CATH-01 | 1 | — |
Expected output
Under review7 expected rowsexpected/adae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AEDECOD | CRIT1FL | DERMFL |
|---|---|---|---|---|---|
| CATH-01 | 1 | HEADACHE | — | — | |
| CATH-01 | 2 | APPLICATION SITE DERMATITIS | Y | Y | |
| CATH-01 | 3 | NAUSEA | — | — | |
| CATH-01 | 4 | ERYTHEMA | Y | Y | |
| CATH-01 | 1 | BLISTER | Y | — | |
| CATH-01 | 2 | VOMITING | — | — | |
| CATH-01 | 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 | CRIT1FL | Criterion 1 Evaluation Result Flag | character | Y | "Y" when str_contains(AE.AEDECOD, 'APPLICATION|DERMATITIS|ERYTHEMA|BLISTER'); blank otherwise. | Derived | |
| ADAE | DERMFL | Dermatologic Event Flag | character | "Y" when str_contains(AE.AEDECOD, 'DERM|ERYTHEMA'); blank otherwise. | Derived |
| Variable | Permitted values |
|---|---|
| CRIT1FL | Y |
| 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 |
Comments
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