As a clinical trial statistician or programmer, answer two short questions in Your review: the task and the inputs and outputs. Agreeing with both approves this benchmark; disagreeing with either needs a comment. Propose a fix with the Edit button on any source file, or add it to your comments.
We suggest spending no more than 5 minutes on a review. The other tabs beside Your review are background for assessment, not under review.
Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give one row for each adverse event and medication of the same
subject recorded at the same visit: their sequence numbers (AESEQ,
CMSEQ) and the visit (VISIT).
Input: one spec.yaml over adverse events and concomitant medications,
each with its subject, its sequence number and the visit it was recorded at.
Variables:
VISIT: the visit the event and the medication were both recorded at.
Note: a record with no subject or no visit pairs with nothing, not even with another record whose visit is also empty: an empty value is no visit that two records can share.
Inputs
Under review2 source filesExpected output
Under review2 expected rowsexpected/aecm.csv
Edit2 rows| USUBJID | AESEQ | CMSEQ | VISIT |
|---|---|---|---|
| 1 | 1 | WEEK 1 | |
| 3 | 1 | WEEK 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| USUBJID | Unique Subject Identifier | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 1 | ||||
| AESEQ | Sequence Number of the Adverse Event | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 2 | ||||
| CMSEQ | Sequence Number of the Medication | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 3 | ||||
| VISIT | Visit Name | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 4 |
| Template | Include when | USUBJID | AESEQ | CMSEQ | VISIT |
|---|---|---|---|---|---|
| pairs | Copy USUBJID from the AE record matching on USUBJID and VISIT, where USUBJID is derived as AE.USUBJID, and no match yields blank | Copy AESEQ from the AE record matching on USUBJID and VISIT, where AESEQ is derived as AE.AESEQ, and no match yields blank | Copy CMSEQ from the AE record matching on USUBJID and VISIT, where CMSEQ is derived as CM.CMSEQ, and no match yields blank | Copy VISIT from the AE record matching on USUBJID and VISIT, where VISIT is derived as AE.VISIT, and no match yields blank |
| 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 |
yamaa