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: carry the collected sex (SEX) for each subject, coded with
the study's controlled terminology for sex.
Input: collected demographics with the study and subject identifiers and the recorded sex code.
Variables:
SEXwould be the subject's recorded sex, one of the codes the terminology lists:F,MorU.
Note: the accepted codes are stated once. The terminology the column is bound to already lists every accepted code, so a second list of the same codes is rejected before any record is read, even when the two lists agree.
How to fix
Remove the allowed_values check. The bound SEX codelist lists its
items, and every non-missing value must equal one of them:
- name: SEX
type: str
label: Sex
derivation: DM_RAW.SEX
submission:
codelist: SEX
origins:
- type: Collected
source: Investigator
To accept fewer codes than the published list, bind a sponsor codelist that lists only those codes instead of narrowing the binding with a second list.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- redundant_declaration
- rule
- CT-9
expected/error.yaml
phase: validation
condition: redundant_declaration
spec_paths:
- columns.SEX.verifications[0].allowed_values
rule: CT-9
context:
column: SEX
codelist: SEX
stated_by: columns.SEX.submission.codelist
Inputs
Under review1 source fileinput/dm_raw.csv
Edit2 rows| STUDYID | USUBJID | SEX |
|---|---|---|
| YAMAA-01 | F | |
| YAMAA-01 | M |
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 DM_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from DM_RAW.USUBJID. | SDTM | 2 | ||||
| SEX | Sex | Char | Sex | Collected | Copy value from DM_RAW.SEX. | SDTM | 3 |
| Codelist ID | Name | Value | Decode | Codelist NCI alias | Value NCI alias | Extensible | Extended value | SAS format | Dictionary | Version |
|---|---|---|---|---|---|---|---|---|---|---|
| SEX | Sex | F | Female | C66731 | C16576 | No | ||||
| SEX | Sex | M | Male | C66731 | C20197 | No | ||||
| SEX | Sex | U | Unknown | C66731 | C17998 | No |
| 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