As a clinical trial statistician or programmer, answer two short questions in Your review: the task and the inputs. Agreeing with both approves this benchmark; disagreeing with either needs a comment. Propose a fix with the Edit button on any source file, or add it to your comments.
We suggest spending no more than 5 minutes on a review. The other tabs beside Your review are background for assessment, not under review.
Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: derive SEX for one record per subject from the subject's
collected answer.
Input: long-form Operational Data Model (ODM) data with one row per collected item. One subject is asked the sex question at screening and again at baseline, and gives the same answer both times.
Variables:
SEXwould be the subject's answer to the sex question.
That subject's question has two records, one per visit. Two records are not one answer even when they agree, so the run stops rather than choosing one, and it names the visit as the field that tells them apart.
How to fix
Decide which visit's answer is the subject's sex, and read that one:
derivation:
odm: {item: ODM.IT.DM.SEX, event: [SCREENING]}
Reading the screening answer gives one record for every subject, whether or not the question was asked again.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- derivation
- condition
- odm_not_unique
- rule
- NAME-13
expected/error.yaml
phase: derivation
condition: odm_not_unique
spec_paths:
- columns.SEX.derivation.odm
rule: NAME-13
context:
item: ODM.IT.DM.SEX
records: 2
differ:
StudyEventOID: [SCREENING, BASELINE]
repeated: false
Inputs
Under review1 source fileinput/odm.csv
Edit5 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | FormOID | FormRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 34 |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | M |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 28 |
| STUDY01 | MDV.1 | 001 | BASELINE | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Collected | Copy value from ODM.StudyOID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from ODM.SubjectKey. | SDTM | 2 | ||||
| SEX | Sex | Char | Collected | Read collected ODM item IT.DM.SEX; no identified record yields blank. | SDTM | 3 |
| 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 |
yamaa