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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build the adverse events domain with each event's
dictionary-derived term (AEDECOD), coded with the study's medical
dictionary.
Input: collected adverse events, one record per event, coded by the sponsor, and the study's codelists in the project file.
Variables:
DOMAINisAEon every record.AESEQwould be the collected sequence number of the event.AETERMwould be the event as the investigator reported it.AEDECODwould be the dictionary term the event was coded to.
Note: the codelist both refers to the medical dictionary and lists two of its terms. A list of terms is the whole set of values a column may hold, while a dictionary reference defers that set to the dictionary, so the two contradict each other, and the run is rejected before any data is read; no artifact is accepted.
How to fix
Refer to the dictionary and its version alone, since a dictionary is too large to list:
- id: MEDDRA
name: Medical Dictionary for Regulatory Activities
external:
dictionary: MedDRA
version: "27.1"
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- codelist_shape_invalid
- rule
- CT-3
expected/error.yaml
phase: validation
condition: codelist_shape_invalid
spec_paths:
- codelists[0].codelists[0]
rule: CT-3
context:
codelist: MEDDRA
Inputs
Under review1 source fileinput/ae_raw.csv
Edit2 rows| STUDYID | USUBJID | AESEQ | AETERM | AEDECOD |
|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | Headache | |
| YAMAA-01 | 1 | FEELING SICK | Nausea |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | Char | 2 | Assigned | Req | Set constant value "AE". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 8 | Protocol | Req | Copy value from RAW.STUDYID. | SDTM | 2 | ||
| USUBJID | Unique Subject Identifier | Char | 12 | Assigned | Req | Copy value from RAW.USUBJID. | SDTM | 3 | ||
| AESEQ | Sequence Number | Num | 8 | Assigned | Req | Copy value from RAW.AESEQ. | SDTM | 4 | ||
| AETERM | Reported Term for the Adverse Event | Char | 12 | Collected | Req | Copy value from RAW.AETERM. | SDTM | 5 | ||
| AEDECOD | Dictionary-Derived Term | Char | 8 | Medical Dictionary for Regulatory Activities (MedDRA, version 27.1) | Assigned | Req | Copy value from RAW.AEDECOD. | SDTM | 6 |
| Codelist ID | Name | Value | Decode | Codelist NCI alias | Value NCI alias | Extensible | Extended value | SAS format | Dictionary | Version |
|---|---|---|---|---|---|---|---|---|---|---|
| MEDDRA | Medical Dictionary for Regulatory Activities | Headache | No | MedDRA | 27.1 | |||||
| MEDDRA | Medical Dictionary for Regulatory Activities | Nausea | No | MedDRA | 27.1 |
| 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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