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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry TRT01A, AGE, HEIGHTBL, TRTSDT and TRTSDTM into
ADSL and submit it as the SAS transport file adsl.xpt, with the dates as
SAS numeric dates.
Input: one pre-analysis row per subject carrying the actual treatment, age, baseline height and the collected date and time of first exposure.
Variables:
TRT01Ais the actual treatment.AGEis the age in years, shown in three positions.HEIGHTBLis the baseline height in centimetres, shown with one decimal; missing when not measured.TRTSDTis the date part ofTRTSDTM; missing when the subject was never treated.TRTSDTMis the date and time of first exposure; missing when the subject was never treated.
Note: in the transport file TRTSDT counts days and TRTSDTM seconds
from 1 January 1960, shown as DATE9. and DATETIME20., and the
data-definition document describes both as eight-byte integers with those
formats. Each text variable is exactly as wide as its longest value.
The project.yaml guide declaration is ADaMIG 1.2; the data-definition
document records it and points to the SAS Transport version 5 dataset.
Inputs
Under review1 source fileinput/adsl_raw.csv
Edit3 rows| STUDYID | USUBJID | TRT01A | AGE | HEIGHTBL | TRTSDTC |
|---|---|---|---|---|---|
| CATH | VITAMIN D3 | 34 | 172.5 | 2025-01-08T08:30 | |
| CATH | PLACEBO | 67 | — | 2025-01-15T09:05:30 | |
| CATH | NOT TREATED | 52 | 165.2 | — |
Expected output
Under review3 expected rowsexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | TRT01A | AGE | HEIGHTBL | TRTSDT | TRTSDTM |
|---|---|---|---|---|---|---|
| CATH | VITAMIN D3 | 34 | 172.5 | 2025-01-08 | 2025-01-08T08:30:00 | |
| CATH | PLACEBO | 67 | — | 2025-01-15 | 2025-01-15T09:05:30 | |
| CATH | NOT TREATED | 52 | 165.2 | — | — |
expected/define.xml
EditDefine-XMLDefine-XML 2.1.11: CATH
Example study submitting subject-level analysis data in SAS transport; CATH-01; ADaMIG 1.2
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID | adsl.xpt |
ADSL
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 4 | Predecessor; ADSL_RAW.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 16 | Predecessor; ADSL_RAW.USUBJID | |
| TRT01A | Actual Treatment for Period 01 | text | 11 | Predecessor; ADSL_RAW.TRT01A | |
| AGE | Age | integer | 3. | Predecessor; ADSL_RAW.AGE | |
| HEIGHTBL | Baseline Height (cm) | float | 5.1 | Predecessor; ADSL_RAW.HEIGHTBL | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9. | Derived; Sponsor Date part of TRTSDTM. | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20. | Predecessor; ADSL_RAW.TRTSDTC |
Original source
<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:def="http://www.cdisc.org/ns/def/v2.1" xmlns:xlink="http://www.w3.org/1999/xlink" ODMVersion="1.3.2" FileType="Snapshot" FileOID="CATH.adam.Define-XML_2.1" CreationDateTime="2026-09-11T00:00:00" SourceSystem="yamaa" SourceSystemVersion="1.0" def:Context="Submission">
<Study OID="STDY.CATH">
<GlobalVariables>
<StudyName>CATH</StudyName>
<StudyDescription>Example study submitting subject-level analysis data in SAS transport</StudyDescription>
<ProtocolName>CATH-01</ProtocolName>
</GlobalVariables>
<MetaDataVersion OID="MDV.CATH.adam" Name="CATH adam metadata" def:DefineVersion="2.1.11">
<def:Standards>
<def:Standard OID="STD.ADaMIG" Name="ADaMIG" Type="IG" Version="1.2" Status="Final"/>
</def:Standards>
<ItemGroupDef OID="IG.ADSL" Name="ADSL" Purpose="Analysis" SASDatasetName="ADSL" Repeating="No" IsReferenceData="No" def:Structure="One record per subject" def:ArchiveLocationID="LF.ADSL" def:StandardOID="STD.ADaMIG">
<Description>
<TranslatedText xml:lang="en">Subject-Level Analysis Dataset</TranslatedText>
</Description>
<ItemRef ItemOID="IT.ADSL.STUDYID" OrderNumber="1" Mandatory="Yes" KeySequence="1"/>
<ItemRef ItemOID="IT.ADSL.USUBJID" OrderNumber="2" Mandatory="Yes" KeySequence="2"/>
<ItemRef ItemOID="IT.ADSL.TRT01A" OrderNumber="3" Mandatory="Yes"/>
<ItemRef ItemOID="IT.ADSL.AGE" OrderNumber="4" Mandatory="Yes"/>
<ItemRef ItemOID="IT.ADSL.HEIGHTBL" OrderNumber="5" Mandatory="No"/>
<ItemRef ItemOID="IT.ADSL.TRTSDT" OrderNumber="6" Mandatory="No" MethodOID="MT.ADSL.TRTSDT"/>
<ItemRef ItemOID="IT.ADSL.TRTSDTM" OrderNumber="7" Mandatory="No"/>
<def:Class Name="SUBJECT LEVEL ANALYSIS DATASET"/>
<def:leaf ID="LF.ADSL" xlink:href="adsl.xpt">
<def:title>adsl.xpt</def:title>
</def:leaf>
</ItemGroupDef>
<ItemDef OID="IT.ADSL.STUDYID" Name="STUDYID" DataType="text" Length="4" SASFieldName="STUDYID">
<Description>
<TranslatedText xml:lang="en">Study Identifier</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.STUDYID</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADSL.USUBJID" Name="USUBJID" DataType="text" Length="16" SASFieldName="USUBJID">
<Description>
<TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.USUBJID</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADSL.TRT01A" Name="TRT01A" DataType="text" Length="11" SASFieldName="TRT01A">
<Description>
<TranslatedText xml:lang="en">Actual Treatment for Period 01</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.TRT01A</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADSL.AGE" Name="AGE" DataType="integer" Length="3" SASFieldName="AGE" def:DisplayFormat="3.">
<Description>
<TranslatedText xml:lang="en">Age</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.AGE</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADSL.HEIGHTBL" Name="HEIGHTBL" DataType="float" Length="5" SignificantDigits="1" SASFieldName="HEIGHTBL" def:DisplayFormat="5.1">
<Description>
<TranslatedText xml:lang="en">Baseline Height (cm)</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.HEIGHTBL</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADSL.TRTSDT" Name="TRTSDT" DataType="integer" Length="8" SASFieldName="TRTSDT" def:DisplayFormat="DATE9.">
<Description>
<TranslatedText xml:lang="en">Date of First Exposure to Treatment</TranslatedText>
</Description>
<def:Origin Type="Derived" Source="Sponsor"/>
</ItemDef>
<ItemDef OID="IT.ADSL.TRTSDTM" Name="TRTSDTM" DataType="integer" Length="8" SASFieldName="TRTSDTM" def:DisplayFormat="DATETIME20.">
<Description>
<TranslatedText xml:lang="en">Datetime of First Exposure to Treatment</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">ADSL_RAW.TRTSDTC</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<MethodDef OID="MT.ADSL.TRTSDT" Name="ADSL.TRTSDT" Type="Computation">
<Description>
<TranslatedText xml:lang="en">Date part of TRTSDTM.</TranslatedText>
</Description>
</MethodDef>
</MetaDataVersion>
</Study>
</ODM>
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Req | Copy value from ADSL_RAW.STUDYID. | Predecessor | |
| ADSL | USUBJID | Unique Subject Identifier | character | Req | Copy value from ADSL_RAW.USUBJID. | Predecessor | |
| ADSL | TRT01A | Actual Treatment for Period 01 | character | Cond | Copy value from ADSL_RAW.TRT01A. | Predecessor | |
| ADSL | AGE | Age | numeric | Req | Copy value from ADSL_RAW.AGE. | Predecessor | |
| ADSL | HEIGHTBL | Baseline Height (cm) | numeric | Perm | Copy value from ADSL_RAW.HEIGHTBL. | Predecessor | |
| ADSL | TRTSDTM | Datetime of First Exposure to Treatment | numeric | ISO 8601 | Perm | Copy value from ADSL_RAW.TRTSDTC. | Predecessor |
| ADSL | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Cond | Date part of TRTSDTM. | 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 |
prompts/adam-adsl-adamig12/full.md
Edit13 linesFollowing CDISC ADaM standards, use the provided ADSL_RAW dataset to create an ADSL dataset with one record per subject.
The output dataset should contain the following columns in this order: STUDYID, USUBJID, TRT01A, AGE, HEIGHTBL, TRTSDT, TRTSDTM
Use ADaMIG 1.2. TRTSDTM is the first-exposure date and time in ADSL_RAW.TRTSDTC, shown as "YYYY-MM-DDThh:mm:ss", with seconds "00" when the source omits seconds. TRTSDT is the calendar date part of TRTSDTM. TRTSDT and TRTSDTM have no value when the subject was never treated.
Read the source datasets from /app/input and save the completed dataset as /app/output/adsl.csv.
prompts/adam-adsl-adamig12/conventions.md
Edit11 linesFollowing CDISC ADaM standards, use the provided ADSL_RAW dataset to create an ADSL dataset with one record per subject.
The output dataset should contain the following columns in this order: STUDYID, USUBJID, TRT01A, AGE, HEIGHTBL, TRTSDT, TRTSDTM
Use ADaMIG 1.2. TRTSDTM is shown as "YYYY-MM-DDThh:mm:ss". TRTSDT and TRTSDTM can have no value.
Read the source datasets from /app/input and save the completed dataset as /app/output/adsl.csv.
prompts/adam-adsl-adamig12/brief.md
Edit8 linesFollowing CDISC ADaM standards, use the provided ADSL_RAW dataset to create an ADSL dataset with one record per subject.
The output dataset should contain the following columns in this order: STUDYID, USUBJID, TRT01A, AGE, HEIGHTBL, TRTSDT, TRTSDTM
Read the source datasets from /app/input and save the completed dataset as /app/output/adsl.csv.
R
Edit3 lineslibrary(yamaa)yamaa_project("project.yaml")$spec("ADSL")$run()$outputPython
Edit3 linesimport yamaayamaa.project("project.yaml").spec("ADSL").run().outputsolutions/adam-adsl-adamig12/result.R
Edit38 lines# Derive ADSL from ADSL_RAW using the requested ADaMIG 1.2 variables.raw <- read.csv("/app/input/adsl_raw.csv", stringsAsFactors = FALSE, check.names = FALSE, na.strings = "")required <- c("STUDYID", "USUBJID", "TRT01A", "AGE", "HEIGHTBL", "TRTSDTC")stopifnot(all(required %in% names(raw)))stopifnot(!anyNA(raw$USUBJID), !anyDuplicated(raw$USUBJID))source_datetime <- trimws(as.character(raw$TRTSDTC))never_treated <- !is.na(raw$TRT01A) & toupper(trimws(raw$TRT01A)) == "NOT TREATED"has_exposure <- !never_treated & !is.na(source_datetime) & nzchar(source_datetime)trtsdtm <- rep(NA_character_, nrow(raw))if (any(has_exposure)) { values <- source_datetime[has_exposure] valid_shape <- grepl( "^[0-9]{4}-[0-9]{2}-[0-9]{2}T[0-9]{2}:[0-9]{2}(:[0-9]{2})?$", values ) if (!all(valid_shape)) stop("Exposure datetime has an unsupported format") values[nchar(values) == 16L] <- paste0(values[nchar(values) == 16L], ":00") parsed <- as.POSIXct(values, format = "%Y-%m-%dT%H:%M:%S", tz = "UTC") normalized <- format(parsed, "%Y-%m-%dT%H:%M:%S", tz = "UTC") if (anyNA(parsed) || !all(normalized == values)) { stop("Invalid exposure date or time") } trtsdtm[has_exposure] <- normalized}adsl <- raw[c("STUDYID", "USUBJID", "TRT01A", "AGE", "HEIGHTBL")]adsl$TRTSDT <- substr(trtsdtm, 1L, 10L)adsl$TRTSDTM <- trtsdtmstopifnot(nrow(adsl) == nrow(raw), !anyDuplicated(adsl$USUBJID))stopifnot(all(is.na(adsl$TRTSDT[never_treated])), all(is.na(adsl$TRTSDTM[never_treated])))dir.create("/app/output", showWarnings = FALSE)write.csv(adsl, "/app/output/adsl.csv", row.names = FALSE, na = "")solutions/adam-adsl-adamig12/result.py
Edit44 lines"""Create the requested ADaMIG 1.2 ADSL extract from ADSL_RAW."""import csvfrom datetime import datetimefrom pathlib import PathINPUT = Path("/app/input/adsl_raw.csv")OUTPUT = Path("/app/output/adsl.csv")COLUMNS = ["STUDYID", "USUBJID", "TRT01A", "AGE", "HEIGHTBL", "TRTSDT", "TRTSDTM"]def main(): records = [] subjects = set() with INPUT.open(newline="", encoding="utf-8-sig") as source: for raw in csv.DictReader(source): subject = (raw["STUDYID"], raw["USUBJID"]) if subject in subjects: raise ValueError( f"ADSL_RAW contains multiple records for subject {subject!r}" ) subjects.add(subject) record = {column: raw[column] for column in COLUMNS[:5]} treatment_start = raw["TRTSDTC"].strip() if treatment_start: timestamp = datetime.fromisoformat(treatment_start) record["TRTSDTM"] = timestamp.strftime("%Y-%m-%dT%H:%M:%S") record["TRTSDT"] = timestamp.date().isoformat() else: record["TRTSDT"] = "" record["TRTSDTM"] = "" records.append(record) OUTPUT.parent.mkdir(parents=True, exist_ok=True) with OUTPUT.open("w", newline="", encoding="utf-8") as destination: writer = csv.DictWriter(destination, fieldnames=COLUMNS, lineterminator="\n") writer.writeheader() writer.writerows(records)if __name__ == "__main__": main()solutions/adam-adsl-adamig12/result.sas
Edit41 lines/* Derive numeric ADaM treatment date and datetime values. */proc import datafile='/app/input/adsl_raw.csv' out=adsl_raw dbms=csv replace; getnames=yes;run;data adsl; retain STUDYID USUBJID TRT01A AGE HEIGHTBL TRTSDT TRTSDTM; set adsl_raw; length _trtsdtc $19; format TRTSDT yymmdd10. TRTSDTM e8601dt19.; if not missing(TRTSDTC) then do; _trtsdtc=strip(TRTSDTC); if lengthn(_trtsdtc)=16 then _trtsdtc=cats(_trtsdtc,':00'); TRTSDTM=input(_trtsdtc,e8601dt.); TRTSDT=datepart(TRTSDTM); end; else do; TRTSDT=.; TRTSDTM=.; end; keep STUDYID USUBJID TRT01A AGE HEIGHTBL TRTSDT TRTSDTM;run;/* CSV export requires explicit formatted character representations. */data adsl_csv; retain STUDYID USUBJID TRT01A AGE HEIGHTBL TRTSDT TRTSDTM; length STUDYID $200 USUBJID $200 TRT01A $200 AGE 8 HEIGHTBL 8 TRTSDT $10 TRTSDTM $19; set adsl(rename=(TRTSDT=_date TRTSDTM=_datetime)); if not missing(_datetime) then do; TRTSDT=put(_date,yymmdd10.); TRTSDTM=put(_datetime,e8601dt19.); end; else do; TRTSDT=''; TRTSDTM=''; end; keep STUDYID USUBJID TRT01A AGE HEIGHTBL TRTSDT TRTSDTM;run;proc export data=adsl_csv outfile='/app/output/adsl.csv' dbms=csv replace;run;
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