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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: show that numbering each subject's collected measurements
(VSSEQ) makes every measurement its own record, so the collection date
(VSDTC) it takes is the date collected beside that measurement, in the
same group of collected items.
Input: one spec.yaml over collected study data in operational data
model form (input/odm.csv: one record per collected item, with the item's
identifier, value and position in the study, event, form and item group).
Each vital signs item group holds a collection date and one or two blood
pressure measurements.
Variables:
VSSEQnumbers each subject's blood pressure measurements from 1 by item group; measurements of one group keep their collected order.VSTESTCDis the test,SYSBPorDIABP, taken from the item's identifier.VSORRESis the measurement as collected.VSDTCis the date collected in the measurement's own item group, and blank when that group has no date.
Note: only the blood pressure items become records. A record's date is looked up among all collected items, so the date item of its group is found although it is not a record itself, and the second group of a subject has its own date.
Inputs
Under review1 source fileinput/odm.csv
Edit6 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | FormOID | FormRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | MDV.1 | 101 | SCREENING | 1 | FO.VS | 1 | IG.VS | 1 | IT.VS.VSDAT | 2024-03-01 |
| YAMAA-01 | MDV.1 | 101 | SCREENING | 1 | FO.VS | 1 | IG.VS | 1 | IT.VS.SYSBP | 132 |
| YAMAA-01 | MDV.1 | 101 | SCREENING | 1 | FO.VS | 1 | IG.VS | 1 | IT.VS.DIABP | 84 |
| YAMAA-01 | MDV.1 | 101 | SCREENING | 1 | FO.VS | 1 | IG.VS | 2 | IT.VS.VSDAT | 2024-03-02 |
| YAMAA-01 | MDV.1 | 101 | SCREENING | 1 | FO.VS | 1 | IG.VS | 2 | IT.VS.SYSBP | 128 |
| YAMAA-01 | MDV.1 | 102 | SCREENING | 1 | FO.VS | 1 | IG.VS | 1 | IT.VS.SYSBP | 140 |
Expected output
Under review4 expected rowsexpected/vs.csv
Edit4 rows| USUBJID | VSSEQ | VSTESTCD | VSORRES | VSDTC |
|---|---|---|---|---|
| 1 | SYSBP | 132 | 2024-03-01 | |
| 2 | DIABP | 84 | 2024-03-01 | |
| 3 | SYSBP | 128 | 2024-03-02 | |
| 1 | SYSBP | 140 | — |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| USUBJID | Unique Subject Identifier | Char | Derived | Fill the template "{ODM.StudyOID}-{ODM.SubjectKey}". | SDTM | 1 | ||||
| VSSEQ | Sequence Number | Num | Derived | Row number within each group of USUBJID, ordered by ODM.ItemGroupRepeatKey. | SDTM | 2 | ||||
| VSTESTCD | Vital Signs Test Short Name | Char | Derived | Extract capture group 1 matching ^IT\.VS\.(.+)$ from ODM.ItemOID. | SDTM | 3 | ||||
| VSORRES | Result or Finding in Original Units | Char | Collected | Copy value from ODM.Value. | SDTM | 4 | ||||
| VSDTC | Date/Time of Measurements | Char | Collected | Read collected ODM item IT.VS.VSDAT; no identified record yields blank. | SDTM | 5 |
| 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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