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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry the actual treatment (TRT01A), age (AGE), baseline
height (HEIGHTBL) and the date and time of first exposure (TRTSDT,
TRTSDTM) into ADSL from a Dataset-JSON file, each value as the stored data
means it.
Input: one spec.yaml reading input/adsl_raw.json, a Clinical Data
Interchange Standards Consortium (CDISC) Dataset-JSON 1.1 file in its
single-object form, with one subject-level record per subject. Each column
of the file states its own data type.
Variables:
TRT01Ais the actual treatment; missing when the subject was never treated, which the file stores as null.AGEis the age in whole years.HEIGHTBLis the baseline height in centimetres, which the file stores as decimal text; missing when not measured.TRTSDTis the date of first exposure; missing when the subject was never treated.TRTSDTMis the date and time of first exposure; missing when the subject was never treated.
Note: each value takes the type its column states: whole numbers stay whole, a decimal written as text is read as a number, and dates and times are read from their ISO 8601 text, a time to the minute gaining zero seconds. A null is missing. The file's labels, lengths and display formats, and its request that a receiving system convert dates to SAS numbers, decide nothing.
Inputs
Under review1 source fileinput/adsl_raw.json
Edit{
"datasetJSONCreationDateTime": "2026-09-30T10:15:00",
"datasetJSONVersion": "1.1.0",
"fileOID": "www.example.org/PILOT7/ADSL_RAW",
"originator": "Example CRO",
"sourceSystem": {"name": "Example EDC", "version": "5.1"},
"studyOID": "PILOT7",
"metaDataVersionOID": "MDV.1",
"itemGroupOID": "IG.ADSL_RAW",
"records": 3,
"name": "ADSL_RAW",
"label": "Subject-Level Source",
"columns": [
{"itemOID": "IT.ADSL_RAW.STUDYID", "name": "STUDYID", "label": "Study Identifier", "dataType": "string", "length": 6, "keySequence": 1},
{"itemOID": "IT.ADSL_RAW.USUBJID", "name": "USUBJID", "label": "Unique Subject Identifier", "dataType": "string", "length": 6, "keySequence": 2},
{"itemOID": "IT.ADSL_RAW.TRT01A", "name": "TRT01A", "label": "Actual Treatment for Period 01", "dataType": "string", "length": 7},
{"itemOID": "IT.ADSL_RAW.AGE", "name": "AGE", "label": "Age", "dataType": "integer", "length": 3},
{"itemOID": "IT.ADSL_RAW.HEIGHTBL", "name": "HEIGHTBL", "label": "Baseline Height (cm)", "dataType": "decimal", "displayFormat": "6.2"},
{"itemOID": "IT.ADSL_RAW.TRTSDT", "name": "TRTSDT", "label": "Date of First Exposure to Treatment", "dataType": "date", "targetDataType": "integer", "displayFormat": "DATE9."},
{"itemOID": "IT.ADSL_RAW.TRTSDTM", "name": "TRTSDTM", "label": "Datetime of First Exposure to Treatment", "dataType": "datetime", "targetDataType": "integer", "displayFormat": "DATETIME20."}
],
"rows": [
["PILOT7", "P7-741", "Drug A", 24, "172.50", "2025-03-04", "2025-03-04T09:15"],
["PILOT7", "P7-742", "Placebo", 67, null, "2025-03-05", "2025-03-05T14:02:37"],
["PILOT7", "P7-743", null, 52, "165.20", null, null]
]
}
Expected output
Under review3 expected rowsexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | TRT01A | AGE | HEIGHTBL | TRTSDT | TRTSDTM |
|---|---|---|---|---|---|---|
| PILOT7 | Drug A | 24 | 172.5 | 2025-03-04 | 2025-03-04T09:15:00 | |
| PILOT7 | Placebo | 67 | — | 2025-03-05 | 2025-03-05T14:02:37 | |
| PILOT7 | — | 52 | 165.2 | — | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from ADSL_RAW.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from ADSL_RAW.USUBJID. | Predecessor | ||
| ADSL | TRT01A | Actual Treatment for Period 01 | character | Copy value from ADSL_RAW.TRT01A. | Predecessor | ||
| ADSL | AGE | Age | numeric | Copy value from ADSL_RAW.AGE. | Predecessor | ||
| ADSL | HEIGHTBL | Baseline Height (cm) | numeric | Copy value from ADSL_RAW.HEIGHTBL. | Predecessor | ||
| ADSL | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL_RAW.TRTSDT. | Predecessor | |
| ADSL | TRTSDTM | Datetime of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL_RAW.TRTSDTM. | Predecessor |
| 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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