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© CDISC 2011
Presented by Tineke Callant
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ADaM 2.1 Implementation:A Challenging Next Step in the Process
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ADaM 2.1 IMPLEMENTATION:A CHALLENGING NEXT STEP IN THE PROCESS
� Flexible
� Delivery of consistent analysis datasets
� Easy to use
� Easy to maintain
� Focus of the presentation:
Any ADaM variable whose name is the same as an SDTM variable must be a copy of the SDTM variable, and its label, meaning, and values must not be modified
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AGENDA
� Reference
� Introduction
� ADaM 2.1: CRO perspective
� Conclusion
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REFERENCE
� CDISC SDTM Implementation Guide Version 3.1.2
� CDISC Analysis Data Model Version 2.1
� CDISC ADaM Implementation Guide Version 1.0
� Case Report Tabulation Data Definition Specification (define.xml) Version 1.0.0
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� Reference
� Introduction
� ADaM 2.1: CRO perspective
� Conclusion
AGENDA
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INTRODUCTION
� CDISC Analysis Data Model (ADaM)
• Fundamental principles
– Provide traceability between the analysis data and its source data
• Practical considerations
– Maintain the values and attributes of SDTM variables
� CDISC ADaM implementation guide
• General variable naming conventions
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� Reference
� Introduction
� ADaM 2.1: CRO perspective
� Conclusion
AGENDA
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ADaM 2.1
� Excel spreadsheet as framework
� Analysis variable metadata
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ADaM 2.1
� Excel spreadsheet as framework
� analysis dataset
� %ADAM(ds_ = )
• Automatization
• Verification
� define.xml
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ADaM 2.1 – %ADAM(ds_ = ) – Automatization
%ADAM(ds_ = ADSL)
Before
After
4 6 5 7 1 2 3
1 2 3 4 5 6 7
ORDER THE ANALYSIS VARIABLES
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ADaM 2.1 – %ADAM(ds_ = ) – Automatization
%ADAM(ds_ = ADSL)
Before
After
LABEL THE ANALYSIS VARIABLES
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ADaM 2.1 – %ADAM(ds_ = ) – Automatization
%ADAM(ds_ = ADSL)
Key variables
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810
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Key variables
Before
After
SORT THE ANALYSIS DATASET
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ADaM 2.1 – %ADAM(ds_ = ) – Verification
Analysis dataset Analysis variable metadata
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ADaM 2.1 – %ADAM(ds_ = ) – Verification
Analysis dataset Analysis variable metadata
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ADaM 2.1 – %ADAM(ds_ = ) – Verification
Analysis dataset Analysis variable metadata
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ADaM 2.1
� Excel spreadsheet as framework
� analysis dataset
� %ADAM(ds_ = )
• Automatization
• Verification
� define.xml
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� SAS variable attributes
� To work in a SAS environment– NAME
– TYPE
– LENGTH
– FORMAT
– INFORMAT
– LABEL
– POSITION IN OBSERVATION
– INDEX TYPE
� Analysis variable metadata fields
– DATASET NAME
– VARIABLE NAME
– VARIABLE LABEL
– VARIABLE TYPE
– DISPLAY FORMAT
– CODELIST /
CONTROLLED TERMS
– SOURCE / DERIVATION
– BASIC DATA STRUCTURE:PARAMETER IDENTIFIER
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� Example
ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
...
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� Subposition in observation
� Example
• ADSL – SITEGR* (Char) and SITEGR*N (Num)
* = a single digit [1-9]
• SITEID
• SITEID grouped together by city in the variable SITEGR1 (SITEGR1N)
• SITEID grouped together by province in the variable SITEGR2 (SITEGR2N)
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
%ADAM(ds_ = ADSL)
1 21 2ORDER
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
ORDER 1 2 1 2
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� Subposition in observation
� Example• ADSL – SITEGR* (Char) and SITEGR*N (Num)
* = a single digit [1-9]
POSITION IN OBSERVATION VARIABLE NAME
1 STUDYID
2 USUBJID
3 SITEID
4 SITEGR1
5 SITEGR1N
6 SITEGR2
7 SITEGR2N
...
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� Subposition in observation
� Example• ADSL – SITEGR* (Char) and SITEGR*N (Num)
* = a single digit [1-9]
POSITION IN OBSERVATION
SUBPOSITION IN OBSERVATION
VARIABLE NAME
1 STUDYID
2 USUBJID
3 SITEID
4 1 SITEGR*
4 2 SITEGR*N
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� Example
ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� Example
...
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ADaM 2.1 – EXCEL SPREADSHEET AS FRAMEWORK
� Excel spreadsheet as framework
� Purpose
• Reference
• Automatization
• Verification
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ADaM 2.1
� Excel spreadsheet as framework
� Analysis variable metadata
• CDISC SDTM Implementation Guide Version 3.1.2
• SUPP --
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� CDISC SDTM Implementation Guide Version 3.1.2
� Example• DM.RACE
– DATASET NAME: ADSL
– PARAMETER IDENTIFIER (NOT APPLICABLE)
– POSITION IN OBSERVATION
– SUBPOSITION IN OBSERVATION
– VARIABLE NAME: RACE
– VARIABLE LABEL: Race
– VARIABLE TYPE: Char
– LENGTH
– DISPLAY FORMAT
– CODELIST / CONTROLLED TERMS
– SOURCE / DERIVATION: DM.RACE
– CORE: Req
– CDISC NOTES: If the variable is not a copy of DM.RACE, an additional differently named variable must be added
ADaM 2.1 – ANALYSIS VARIABLE METADATA
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ADaM 2.1 – ANALYSIS VARIABLE METADATA
� CDISC SDTM Implementation Guide Version 3.1.2
� Example
� Excel spreadsheet
?
(race)
...
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ADaM 2.1 – ANALYSIS VARIABLE METADATA –LENGTH
� CDISC SDTM Implementation Guide Version 3.1.2
SAS length variable attribute of character variables guidelines:• Variables of the same name in separate datasets should have the
same SAS Length attribute• Version 5 SAS transport file format: max. 200 characters• -- TESTCD and QNAM: max. 8 characters• -- TEST and QLABEL: max. 40 characters
� Problem when working with different sponsors:• Example
DM.RACE– $41– $50– $200
� Solution: [sdtm] ↔ %ADAM(ds_ = )
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ADaM 2.1 – ANALYSIS VARIABLE METADATA
� CDISC SDTM Implementation Guide Version 3.1.2
� Example
� Excel spreadsheet
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ADaM 2.1
� Excel spreadsheet as framework
� Analysis variable metadata
• CDISC SDTM Implementation Guide Version 3.1.2
• SUPP --
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ADaM 2.1 – ANALYSIS VARIABLE METADATA
� SUPP --
• QNAM → variable name
• QLABEL → variable label
• QVAL → variable type: Char
→ variable length
e.g. SUPPDM SDTM dataset e.g. ADSL ADaM dataset
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ADaM 2.1 – ANALYSIS VARIABLE METADATA
� Problem when working with different sponsors:
• QLABEL is different for the same QNAM
– Example
ELIGCONF Subject Still Eligible
ELIGCONF Still Fulfill Eligibility Criteria
• QLABEL format
– Example
RANDNO RANDOMIZATION NUMBER
RANDNO Randomization Number
• QLABEL changes during the course of a study
– Example
ELIGIBLE Suject Eligible For Dosing
ELIGIBLE Subject Eligible For Dosing
� Solution: [supp] ↔ %ADAM(ds_ = )
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� Reference
� Introduction
� ADaM 2.1: CRO perspective
� Conclusion
AGENDA
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CONCLUSION
� SDTM and ADaM go hand in hand
� Thus, without a CDISC compliant SDTM database to start from, ADaM cannot exist
� But do realize a strong analysis data model needs more than a CDISC compliant SDTM database alone
