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: show that a record's identity may be computed from that one
record, through the project's own routine and through the subject's planned
dose: one record per subject and dose level received (DOSE), stating
whether the level is above the subject's planned dose (ABOVEFL) and what
that planned dose is (PLANDOSE).
Input: one spec.yaml over exposure records (input/ex.csv: one per
administration, with the study day and the dose given) and each subject's
planned dose (input/plan.csv). The project.yaml lists the function
file functions/project_value.yaml, whose routine returns the dose it is
given.
Variables:
DOSEis a dose level the subject received, as the project's routine returns it.ABOVEFLisYwhen that dose is above the subject's planned dose andNotherwise.PLANDOSEis the subject's planned dose.
Note: each administration contributes its own dose and flag, so a level the subject received several times gives one record, while a different level gives another, each in the order of its first administration.
Inputs
Under review2 source filesExpected output
Under review3 expected rowsexpected/adex.csv
Edit3 rows| USUBJID | DOSE | ABOVEFL | PLANDOSE |
|---|---|---|---|
| 50 | N | 50 | |
| 100 | Y | 50 | |
| 50 | N | 100 |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADEX | USUBJID | Unique Subject Identifier | character | Copy value from EX.USUBJID. | Predecessor | ||
| ADEX | DOSE | Dose | numeric | Call project function project_value with x = EX.EXDOSE. | Derived | ||
| ADEX | ABOVEFL | Dose Above Planned Flag | character | "Y" when EX.EXDOSE > PLANDOSE, with PLANDOSE taken from the PLAN record matching on USUBJID, and a row with no match is an error; "N" otherwise; blank when the condition is unknown. | Derived | ||
| ADEX | PLANDOSE | Planned Dose | numeric | Take PLANDOSE from the PLAN record matching on USUBJID, and a row with no match is an error. | Derived |
| 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