yamaa 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
EditUnder reviewWhat this benchmark meansREADME.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give one row for each adverse event and each medication of the same
subject given for it, with their sequence numbers (AESEQ, CMSEQ), the
event's term (AETERM) and the medication's name (CMTRT), in the order the
two files store them.
Input: one spec.yaml over adverse events, each with its sequence number
and reported term, and concomitant medications, each with its sequence
number, name and indication, the indication written as the term of the event
it was given for. Neither file is sorted by subject, term or sequence number.
Variables:
AETERM: the reported term of the adverse event.CMTRT: the name of a medication of the same subject whose indication is the event's term.
Note: the rows follow the adverse events in the order the events file stores them, and each event's medications in the order the medications file stores them, whatever their subjects, terms or sequence numbers. Sorting the rows by subject and term, by sequence number, or by medication first gives another order.
Inputs
Under review2 source filesExpected output
Under review8 expected rowsexpected/aecm.csv
Edit8 rows| USUBJID | AESEQ | CMSEQ | AETERM | CMTRT |
|---|---|---|---|---|
| 1 | 2 | HEADACHE | PARACETAMOL | |
| 1 | 1 | HEADACHE | IBUPROFEN | |
| 3 | 4 | NAUSEA | ONDANSETRON | |
| 3 | 3 | NAUSEA | METOCLOPRAMIDE | |
| 1 | 2 | HEADACHE | PARACETAMOL | |
| 1 | 1 | HEADACHE | IBUPROFEN | |
| 2 | 4 | NAUSEA | ONDANSETRON | |
| 2 | 3 | NAUSEA | METOCLOPRAMIDE |
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 | ||||
| AETERM | Reported Term for the Adverse Event | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 4 | ||||
| CMTRT | Reported Name of Drug, Med, or Therapy | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 5 |
| Template | Include when | USUBJID | AESEQ | CMSEQ | AETERM | CMTRT |
|---|---|---|---|---|---|---|
| pairs | Copy USUBJID from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where USUBJID is derived as AE.USUBJID, and no match yields blank | Copy AESEQ from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where AESEQ is derived as AE.AESEQ, and no match yields blank | Copy CMSEQ from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where CMSEQ is derived as CM.CMSEQ, and no match yields blank | Copy AETERM from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where AETERM is derived as AE.AETERM, and no match yields blank | Copy CMTRT from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where CMTRT is derived as CM.CMTRT, 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 |