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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry each vital signs result with its collection date and time
(VSDTC).
Input: collected vital signs records, each identified by study, subject and sequence, carrying the test, the result and the collection date and time as ISO 8601 text, collected to the minute or the second.
Variables:
VSDTCwould be the collection date and time. Held as a date-time value, a time collected to the minute,2026-01-06T08:30, would be written2026-01-06T08:30:00, claiming seconds no one collected. A tabulation dataset keeps the collected text, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Keep the date and time as the collected text, at the precision it was collected, and state its ISO 8601 type for reviewers. Text collected to the minute or a coarser precision is a partial date-time:
- name: VSDTC
type: str
label: Date/Time of Measurements
derivation: VS_RAW.VSDTC
submission:
core: Exp
data_type: partialDatetime
origins:
- type: Collected
source: Investigator
A comparison or lookup that needs a moment completes the text into an
internal datetime column that the dataset does not carry.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- value_not_permitted
- rule
- SUB-27
expected/error.yaml
phase: validation
condition: value_not_permitted
spec_paths:
- columns.VSDTC.type
rule: SUB-27
context:
column: VSDTC
value: datetime
class: FINDINGS
Inputs
Under review1 source fileinput/vs_raw.csv
Edit2 rows| STUDYID | USUBJID | VSSEQ | VSTESTCD | VSORRES | VSDTC |
|---|---|---|---|---|---|
| YAMAA-01 | 1 | SYSBP | 128 | 2026-01-06T08:30 | |
| YAMAA-01 | 2 | SYSBP | 132 | 2026-01-13T10:15:42 |
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 VS_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from VS_RAW.USUBJID. | SDTM | 2 | ||||
| VSSEQ | Sequence Number | Num | Collected | Copy value from VS_RAW.VSSEQ. | SDTM | 3 | ||||
| VSTESTCD | Vital Signs Test Short Name | Char | Collected | Copy value from VS_RAW.VSTESTCD. | SDTM | 4 | ||||
| VSORRES | Result or Finding in Original Units | Char | Collected | Copy value from VS_RAW.VSORRES. | SDTM | 5 | ||||
| VSDTC | Date/Time of Measurements | Char | ISO 8601 | Collected | Copy value from VS_RAW.VSDTC. | SDTM | 6 |
| 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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