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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: record SEX as unknown for each subject after review, even when the
extract contains a collected answer.
Input: long-form Operational Data Model (ODM) data with one row per collected item, including a repeated sex answer at another visit.
Variables:
SEXisUfor each subject. The reviewed value replaces the collected answer, including when that answer appears more than once.
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 | 001 | SCREENING | 1 | FO.VS | 1 | IG.VS | 1 | IT.VS.WEIGHT | 61 |
| STUDY01 | MDV.1 | 001 | BASELINE | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | M |
Expected output
Under review2 expected rowsexpected/dm.csv
Edit2 rows| STUDYID | USUBJID | SEX |
|---|---|---|
| STUDY01 | U | |
| STUDY01 | U |
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 | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 2 | ||||
| SEX | Sex | Char | Collected | Read collected ODM item IT.DM.SEX; no identified record yields blank. | SDTM | 3 |
| Template | Include when | STUDYID | USUBJID | SEX |
|---|---|---|---|---|
| subjects | Copy ODM.StudyOID | Copy ODM.SubjectKey | Constant "U" |
| 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 |
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