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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry the reason for discontinuation from the study (DCSREAS)
into ADSL, restricted to this submission package's own list of reasons.
Input: one pre-analysis row per subject carrying the reason the subject left the study, and two sets of coded values: the study's, which every submission package of the study shares, and this package's own.
Variables:
DCSREASwould be the reason for discontinuation from the study, one of the package's reasons.
Note: the package means to replace the study's list of reasons, but declares its own under another code. The study's list is then kept beside it, and the two lists carry one name, so a reader of the data-definition document could not tell them apart; the run is rejected before any data is read.
How to fix
Decide whether the package changes the study's list or adds a second one.
To change it, declare the package's list under the study's id, which
replaces the study's list whole, and bind that id:
codelists:
- id: DCSREAS
name: Reason for Discontinuation
items:
- {value: ADVERSE EVENT, decode: ADVERSE EVENT}
A list the package adds beside the study's takes a name of its own.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- duplicate_define_identifier
- rule
- CT-1
expected/error.yaml
phase: validation
condition: duplicate_define_identifier
spec_paths:
- codelists[0].name
rule: CT-1
context:
codelist: DCSREASP
field: name
name: Reason for Discontinuation
identifier: Reason for Discontinuation
environment_path: codelists[1]
Inputs
Under review1 source fileinput/adsl_raw.csv
Edit2 rows| STUDYID | USUBJID | DCSREAS |
|---|---|---|
| CATH | COMPLETED | |
| CATH | ADVERSE EVENT |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
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 | DCSREAS | Reason for Discontinuation from Study | character | Reason for Discontinuation | Copy value from ADSL_RAW.DCSREAS. | Predecessor |
| Codelist ID | Name | Value | Decode | Codelist NCI alias | Value NCI alias | Extensible | Extended value | SAS format | Dictionary | Version |
|---|---|---|---|---|---|---|---|---|---|---|
| DCSREAS | Reason for Discontinuation | ADVERSE EVENT | Adverse Event | No | ||||||
| DCSREAS | Reason for Discontinuation | COMPLETED | Completed | No | ||||||
| DCSREAS | Reason for Discontinuation | WITHDRAWAL BY SUBJECT | Withdrawal by Subject | No | ||||||
| DCSREASP | Reason for Discontinuation | ADVERSE EVENT | ADVERSE EVENT | No | ||||||
| DCSREASP | Reason for Discontinuation | COMPLETED | COMPLETED | No | ||||||
| DCSREASP | Reason for Discontinuation | WITHDRAWAL BY SUBJECT | WITHDRAWAL BY SUBJECT | No |
| 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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