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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: submit the adverse event analysis dataset (ADAE), with the
dictionary-derived term of each event (AEDECOD), as the SAS transport file
adae.xpt.
Input: the collected adverse event listing of a study in which no subject had an adverse event, so the listing holds only its header.
Variables:
AEDECODwould be the dictionary-derived term of each adverse event.
The dataset has no rows. An empty transport file looks like a dataset that was lost on its way into the package, so a dataset with no rows must state that it has no data: the package then describes it as empty and carries no transport file for it. This dataset states nothing, so the submission is rejected before any file is written.
How to fix
Confirm that the study collected no adverse events, then state it in the dataset's submission metadata:
submission:
label: Adverse Events Analysis Dataset
class: OCCURRENCE DATA STRUCTURE
structure: One record per subject per adverse event
repeating: true
has_no_data: true
The data-definition document then describes ADAE as a dataset with no data,
and no adae.xpt is written.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- output
- condition
- transport_dataset_empty
- rule
- JSON-3
expected/error.yaml
phase: output
condition: transport_dataset_empty
spec_paths:
- datasets.ADAE.artifact
rule: JSON-3
context:
dataset: ADAE
Inputs
Under review1 source fileUnexpected Output
Under review0 rows presented to the failing check - not an accepted artifactHuman review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Req | Copy value from AE.STUDYID. | Predecessor | |
| ADAE | USUBJID | Unique Subject Identifier | character | Req | Copy value from AE.USUBJID. | Predecessor | |
| ADAE | AESEQ | Sequence Number | numeric | Req | Copy value from AE.AESEQ. | Predecessor | |
| ADAE | AEDECOD | Dictionary-Derived Term | character | Req | Copy value from AE.AEDECOD. | 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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