Review ask
As a clinical trial statistician or programmer, challenge anything in this benchmark: describe a problem in Comments, or propose a fix with the Edit button on any source file.
- Task: Would a real study need this derivation, specified this way? Does it follow CDISC ADaM: variable names, controlled terms, record structure? Flag any rule that is ambiguous or that a sponsor would handle differently.
- Inputs: Do they look like data collected in a real trial, and do they include the situations you would expect to meet in one?
- Expected output: Would independent QC programming reproduce every value from these inputs and rules?
The other tabs beside Comments are background for assessment, not under review.
Summary
README.mdGoal: pin how each column's value is written and read: fixed values, values copied by naming their source column, age bands, a population flag chosen by a condition, first-available country selection, joining text, and the largest and smallest of several collected weights.
Input: one spec.yaml. DM carries one record per subject: sex,
age, first-dose date, country, site country, and two collected
weights, any of which may be blank.
Columns:
STUDYIDholds a fixed study code written directly in the column.USUBJIDandSEXcopy the collected values by naming the source column alone.AGEGRPplaces each age in a band: under 18, 18 to 64, or 65 and over. Each band includes its lower edge, so an age of exactly 65 is in the oldest band and an age of exactly 18 is in the middle band; a 12-year-old exercises the youngest band. A subject with no age carries the fallback textNOT REPORTED.SAFFLflags the safety population:Yfor a subject with a first-dose date,Nfor a subject without one.COUNTRYtakes the subject's own country, or the site country when the subject's own entry is blank. When both are blank it carries the declared fallback text.SUBJLBLjoins the fixed wordSubjectto the subject number.WTMAXcarries the larger of the two collected weights, skipping a blank one; with both blank it stays blank.WTMINcarries the smaller of the two collected weights, skipping a blank one; with both blank it stays blank.
Inputs
Under review1 source fileinput/dm.csv
Edit6 rows| STUDYID | USUBJID | SUBJID | SEX | AGE | RFXSTDTC | COUNTRY | SITECNTY | WT_SCR | WT_BL |
|---|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | 001 | M | 65 | 2026-01-12 | USA | USA | 70 | 72 | |
| YAMAA-01 | 002 | F | 40 | 2026-01-19 | — | CAN | — | 68 | |
| YAMAA-01 | 003 | M | — | — | — | — | — | — | |
| YAMAA-01 | 004 | F | 25 | 2026-02-02 | GBR | GBR | 55 | 55 | |
| YAMAA-01 | 005 | F | 18 | 2026-02-10 | USA | — | 80 | 75 | |
| YAMAA-01 | 006 | M | 12 | — | GBR | GBR | 45 | 45 |
Expected output
Under review6 expected rowsexpected/adsl.csv
Edit6 rows| STUDYID | USUBJID | SEX | AGEGRP | SAFFL | COUNTRY | SUBJLBL | WTMAX | WTMIN |
|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | M | 65+ | Y | USA | Subject 001 | 72 | 70 | |
| YAMAA-01 | F | 18-64 | Y | CAN | Subject 002 | 68 | 68 | |
| YAMAA-01 | M | NOT REPORTED | N | UNKNOWN | Subject 003 | — | — | |
| YAMAA-01 | F | 18-64 | Y | GBR | Subject 004 | 55 | 55 | |
| YAMAA-01 | F | 18-64 | Y | USA | Subject 005 | 80 | 75 | |
| YAMAA-01 | M | <18 | N | GBR | Subject 006 | 45 | 45 |
Shaded columns are derived— = missing value
Comments and assessment materials
Not under review
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Set constant value "YAMAA-01". | Assigned | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | SEX | Sex | character | Copy value from DM.SEX. | Predecessor | ||
| ADSL | AGEGRP | Age Group | character | Band DM.AGE at 18, 65 into "<18", "18-64" and "65+", intervals closed on the left; a missing source → "NOT REPORTED". | Derived | ||
| ADSL | SAFFL | Safety Population Flag | character | If DM.RFXSTDTC IS NOT NULL then "Y"; otherwise "N". | Derived | ||
| ADSL | COUNTRY | Country | character | First non-missing of DM.COUNTRY and DM.SITECNTY; all missing → "UNKNOWN". | Derived | ||
| ADSL | SUBJLBL | Subject Label | character | Concatenate "Subject " and DM.SUBJID. | Derived | ||
| ADSL | WTMAX | Highest Recorded Weight | numeric | Greatest of DM.WT_SCR and DM.WT_BL. | Derived | ||
| ADSL | WTMIN | Lowest Recorded Weight | numeric | Least of DM.WT_SCR and DM.WT_BL. | Derived |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 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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Comments
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