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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build one timeline row per subject, adverse event and
concomitant medication, and complete the start date (STDT) of every
event and medication row from the record that built it.
Input: one spec.yaml over the subjects (input/dm.csv: domain,
subject and reference start date), their adverse events
(input/ae.csv: domain, subject, sequence, reported term and start
date) and their concomitant medications (input/cm.csv: domain,
subject, sequence, medication name and start date).
Variables:
SEQ: the sequence number of the record behind the row, and1on the subject's own row.TERM: the reported adverse event term or medication name, andREFERENCE STARTon the subject's own row.STDT: the start date collected on the record behind the row: the adverse event's or the medication's own start date, and the subject's reference start date on the subject's row; blank when that record has no start date.
Note: the start date is stated once for the event and medication rows, naming the start dates of both. Each row reads the date of its own record. The other file is matched on the subject and the domain, so a medication row never takes an adverse event's date, and an event without a start date stays blank even when the subject's medication has one.
Inputs
Under review3 source filesinput/ae.csv
Edit3 rows| DOMAIN | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| AE | 1 | HEADACHE | 2024-03-04 | |
| AE | 2 | NAUSEA | 2024-03-11 | |
| AE | 1 | RASH | — |
input/cm.csv
Edit3 rows| DOMAIN | USUBJID | CMSEQ | CMTRT | CMSTDTC |
|---|---|---|---|---|
| CM | 1 | PARACETAMOL | 2024-03-04 | |
| CM | 1 | IBUPROFEN | 2024-02-20 | |
| CM | 2 | OMEPRAZOLE | — |
input/dm.csv
Edit3 rows| DOMAIN | USUBJID | RFSTDTC |
|---|---|---|
| DM | 2024-03-01 | |
| DM | 2024-03-02 | |
| DM | 2024-02-15 |
Expected output
Under review9 expected rowsexpected/timeline.csv
Edit9 rows| DOMAIN | USUBJID | SEQ | TERM | STDT |
|---|---|---|---|---|
| DM | 1 | REFERENCE START | 2024-03-01 | |
| DM | 1 | REFERENCE START | 2024-03-02 | |
| DM | 1 | REFERENCE START | 2024-02-15 | |
| AE | 1 | HEADACHE | 2024-03-04 | |
| AE | 2 | NAUSEA | 2024-03-11 | |
| AE | 1 | RASH | — | |
| CM | 1 | PARACETAMOL | 2024-03-04 | |
| CM | 1 | IBUPROFEN | 2024-02-20 | |
| CM | 2 | OMEPRAZOLE | — |
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 | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 2 | ||||
| SEQ | Sequence Number | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 3 | ||||
| TERM | Reported Term | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 4 | ||||
| STDT | Start Date | Char | ISO 8601 | Derived | First non-missing of AE.AESTDTC and CM.CMSTDTC. | SDTM | 5 |
| Template | Include when | DOMAIN | USUBJID | SEQ | TERM | STDT |
|---|---|---|---|---|---|---|
| subjects | Copy DM.DOMAIN | Copy DM.USUBJID | Constant "1" | Constant "REFERENCE START" | Copy DM.RFSTDTC | |
| adverse_events | Copy AE.DOMAIN | Copy AE.USUBJID | Copy AE.AESEQ | Copy AE.AETERM | None | |
| medications | Copy CM.DOMAIN | Copy CM.USUBJID | Copy CM.CMSEQ | Copy CM.CMTRT | None |
| 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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