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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build the analysis values of systolic blood pressure, AVAL, at
each visit and as each subject's average, with PARAMCD, AVISIT and
DTYPE, and give the observed and the averaged values their own definitions
in the data-definition document.
Input: spec.yaml reads the subjects' systolic blood pressure, one row
per subject per visit, and project.yaml submits the analysis dataset.
Variables:
PARAMCDisSYSBP, systolic blood pressure.AVISITis the visit of an observed value, andOVERALLfor an average.DTYPEisAVERAGEon a subject's average, and empty on an observed value.AVALis the observed value, or the mean of the subject's observed values over all visits.
Note: the data-definition document describes AVAL twice: once for the
rows whose DTYPE is anything but AVERAGE, which takes in the observed
rows, where it is empty, copied from the collected value; and once for the
averaged rows, derived by the mean. The two descriptions select no common
row.
Inputs
Under review1 source fileinput/vs.csv
Edit4 rows| STUDYID | USUBJID | VSTESTCD | VISIT | VSSTRESN |
|---|---|---|---|---|
| BP01 | SYSBP | WEEK 1 | 128 | |
| BP01 | SYSBP | WEEK 2 | 124 | |
| BP01 | SYSBP | WEEK 1 | 141 | |
| BP01 | SYSBP | WEEK 2 | 137 |
Expected output
Under review6 expected rowsexpected/advs.csv
Edit6 rows| STUDYID | USUBJID | PARAMCD | AVISIT | DTYPE | AVAL |
|---|---|---|---|---|---|
| BP01 | SYSBP | WEEK 1 | — | 128 | |
| BP01 | SYSBP | WEEK 2 | — | 124 | |
| BP01 | SYSBP | WEEK 1 | — | 141 | |
| BP01 | SYSBP | WEEK 2 | — | 137 | |
| BP01 | SYSBP | OVERALL | AVERAGE | 126 | |
| BP01 | SYSBP | OVERALL | AVERAGE | 139 |
expected/define.xml
EditDefine-XMLDefine-XML 2.1.11: BP01
Example study averaging each subject's blood pressure; BP-01; ADaMIG 1.3
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| ADVS | Vital Signs Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per parameter per analysis visit | Analysis | STUDYID, USUBJID, PARAMCD, AVISIT | advs.csv |
ADVS
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 4 | Predecessor; VS.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 8 | Predecessor; VS.USUBJID | |
| PARAMCD | Parameter Code | text | 5 | Assigned; Sponsor | |
| AVISIT | Analysis Visit | text | 7 | Assigned; Sponsor | |
| DTYPE | Derivation Type | text | 7 | Assigned; Sponsor | |
| AVAL | Analysis Value | float | 8 | Other; Sponsor; Observed or averaged, as each value-level definition states |
| Where Condition | Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| DTYPE != AVERAGE | AVAL | Analysis Value | float | 8 | Predecessor; VS.VSSTRESN | |
| DTYPE = AVERAGE | AVAL | Analysis Value | float | 8 | Derived; Sponsor Mean of the subject's observed values over all visits |
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="BP01.adam.Define-XML_2.1" CreationDateTime="2026-09-11T00:00:00" SourceSystem="yamaa" SourceSystemVersion="1.0" def:Context="Other">
<Study OID="STDY.BP01">
<GlobalVariables>
<StudyName>BP01</StudyName>
<StudyDescription>Example study averaging each subject's blood pressure</StudyDescription>
<ProtocolName>BP-01</ProtocolName>
</GlobalVariables>
<MetaDataVersion OID="MDV.BP01.adam" Name="BP01 adam metadata" def:DefineVersion="2.1.11">
<def:Standards>
<def:Standard OID="STD.ADaMIG" Name="ADaMIG" Type="IG" Version="1.3" Status="Final"/>
</def:Standards>
<def:ValueListDef OID="VL.ADVS.AVAL">
<ItemRef ItemOID="IT.ADVS.AVAL.OBSERVED" OrderNumber="1" Mandatory="Yes">
<def:WhereClauseRef WhereClauseOID="WC.ADVS.AVAL.OBSERVED"/>
</ItemRef>
<ItemRef ItemOID="IT.ADVS.AVAL.AVERAGE" OrderNumber="2" Mandatory="Yes" MethodOID="MT.ADVS.AVAL.AVERAGE">
<def:WhereClauseRef WhereClauseOID="WC.ADVS.AVAL.AVERAGE"/>
</ItemRef>
</def:ValueListDef>
<def:WhereClauseDef OID="WC.ADVS.AVAL.OBSERVED">
<RangeCheck Comparator="NE" SoftHard="Soft" def:ItemOID="IT.ADVS.DTYPE">
<CheckValue>AVERAGE</CheckValue>
</RangeCheck>
</def:WhereClauseDef>
<def:WhereClauseDef OID="WC.ADVS.AVAL.AVERAGE">
<RangeCheck Comparator="EQ" SoftHard="Soft" def:ItemOID="IT.ADVS.DTYPE">
<CheckValue>AVERAGE</CheckValue>
</RangeCheck>
</def:WhereClauseDef>
<ItemGroupDef OID="IG.ADVS" Name="ADVS" Purpose="Analysis" SASDatasetName="ADVS" Repeating="Yes" IsReferenceData="No" def:Structure="One record per subject per parameter per analysis visit" def:ArchiveLocationID="LF.ADVS" def:StandardOID="STD.ADaMIG">
<Description>
<TranslatedText xml:lang="en">Vital Signs Analysis Dataset</TranslatedText>
</Description>
<ItemRef ItemOID="IT.ADVS.STUDYID" OrderNumber="1" Mandatory="Yes" KeySequence="1"/>
<ItemRef ItemOID="IT.ADVS.USUBJID" OrderNumber="2" Mandatory="Yes" KeySequence="2"/>
<ItemRef ItemOID="IT.ADVS.PARAMCD" OrderNumber="3" Mandatory="Yes" KeySequence="3"/>
<ItemRef ItemOID="IT.ADVS.AVISIT" OrderNumber="4" Mandatory="Yes" KeySequence="4"/>
<ItemRef ItemOID="IT.ADVS.DTYPE" OrderNumber="5" Mandatory="No"/>
<ItemRef ItemOID="IT.ADVS.AVAL" OrderNumber="6" Mandatory="Yes"/>
<def:Class Name="BASIC DATA STRUCTURE"/>
<def:leaf ID="LF.ADVS" xlink:href="advs.csv">
<def:title>advs.csv</def:title>
</def:leaf>
</ItemGroupDef>
<ItemDef OID="IT.ADVS.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">VS.STUDYID</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADVS.USUBJID" Name="USUBJID" DataType="text" Length="8" SASFieldName="USUBJID">
<Description>
<TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">VS.USUBJID</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADVS.PARAMCD" Name="PARAMCD" DataType="text" Length="5" SASFieldName="PARAMCD">
<Description>
<TranslatedText xml:lang="en">Parameter Code</TranslatedText>
</Description>
<def:Origin Type="Assigned" Source="Sponsor"/>
</ItemDef>
<ItemDef OID="IT.ADVS.AVISIT" Name="AVISIT" DataType="text" Length="7" SASFieldName="AVISIT">
<Description>
<TranslatedText xml:lang="en">Analysis Visit</TranslatedText>
</Description>
<def:Origin Type="Assigned" Source="Sponsor"/>
</ItemDef>
<ItemDef OID="IT.ADVS.DTYPE" Name="DTYPE" DataType="text" Length="7" SASFieldName="DTYPE">
<Description>
<TranslatedText xml:lang="en">Derivation Type</TranslatedText>
</Description>
<def:Origin Type="Assigned" Source="Sponsor"/>
</ItemDef>
<ItemDef OID="IT.ADVS.AVAL" Name="AVAL" DataType="float" Length="8" SignificantDigits="1" SASFieldName="AVAL">
<Description>
<TranslatedText xml:lang="en">Analysis Value</TranslatedText>
</Description>
<def:Origin Type="Other" Source="Sponsor">
<Description>
<TranslatedText xml:lang="en">Observed or averaged, as each value-level definition states</TranslatedText>
</Description>
</def:Origin>
<def:ValueListRef ValueListOID="VL.ADVS.AVAL"/>
</ItemDef>
<ItemDef OID="IT.ADVS.AVAL.OBSERVED" Name="AVAL" DataType="float" Length="8" SignificantDigits="1" SASFieldName="AVAL">
<Description>
<TranslatedText xml:lang="en">Analysis Value</TranslatedText>
</Description>
<def:Origin Type="Predecessor">
<Description>
<TranslatedText xml:lang="en">VS.VSSTRESN</TranslatedText>
</Description>
</def:Origin>
</ItemDef>
<ItemDef OID="IT.ADVS.AVAL.AVERAGE" Name="AVAL" DataType="float" Length="8" SignificantDigits="1" SASFieldName="AVAL">
<Description>
<TranslatedText xml:lang="en">Analysis Value</TranslatedText>
</Description>
<def:Origin Type="Derived" Source="Sponsor"/>
</ItemDef>
<MethodDef OID="MT.ADVS.AVAL.AVERAGE" Name="ADVS.AVAL.AVERAGE" Type="Computation">
<Description>
<TranslatedText xml:lang="en">Mean of the subject's observed values over all visits</TranslatedText>
</Description>
</MethodDef>
</MetaDataVersion>
</Study>
</ODM>
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADVS | STUDYID | Study Identifier | character | Req | Copy value from VS.STUDYID. | Predecessor | |
| ADVS | USUBJID | Unique Subject Identifier | character | Req | Copy value from VS.USUBJID. | Predecessor | |
| ADVS | PARAMCD | Parameter Code | character | Req | Set constant value "SYSBP". | Assigned | |
| ADVS | AVISIT | Analysis Visit | character | Cond | Set per constructed row; see the Row construction sheet. | Assigned | |
| ADVS | DTYPE | Derivation Type | character | Cond | Set per constructed row; see the Row construction sheet. | Assigned | |
| ADVS | AVAL | Analysis Value | numeric | Cond | Set per constructed row; see the Row construction sheet. | Other |
| Template | Include when | AVISIT | DTYPE | AVAL |
|---|---|---|---|---|
| observed | Copy VS.VISIT | Constant "None" | Copy VS.VSSTRESN | |
| average | Constant "OVERALL" | Constant "AVERAGE" | Aggregate MEAN(VS.VSSTRESN) over records matching on the shared output keys |
| 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 |
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