ADaM 2.

1 Implementation:
A Challenging Next Step in the Process
Presented by Tineke Callant

© CDISC 2011 1
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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AGENDA

Reference

Introduction

ADaM 2.1: CRO perspective

Conclusion

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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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AGENDA

Reference

Introduction

ADaM 2.1: CRO perspective

Conclusion

7
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
4 6 5 7 1 2 3
Before

ORDER THE ANALYSIS VARIABLES %ADAM(ds_ = ADSL)

1 2 3 4 5 6 7
After

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 ADaM 2.1 – %ADAM(ds_ = ) – Automatization

Before

LABEL THE ANALYSIS VARIABLES %ADAM(ds_ = ADSL)

After

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 ADaM 2.1 – %ADAM(ds_ = ) – Automatization
Key variables

2
1
3
4
7
Before 5
6
9
8
10

SORT THE ANALYSIS DATASET %ADAM(ds_ = ADSL)

Key variables

1
2
3
4

After 6
5

7
8
9
10

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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
Analysis variable metadata fields

To work in a SAS environment
– DATASET NAME
– NAME
– VARIABLE NAME
– TYPE
– VARIABLE LABEL
– LENGTH
– VARIABLE TYPE
– FORMAT
– DISPLAY FORMAT
– INFORMAT
– CODELIST /
– LABEL
CONTROLLED TERMS
– POSITION IN
OBSERVATION – SOURCE / DERIVATION
– INDEX TYPE – BASIC DATA STRUCTURE:
PARAMETER IDENTIFIER

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ADaM 2.1 – EXCEL SPREADSHEET AS
FRAMEWORK

Example

...

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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

ORDER 1 1 2 2

%ADAM(ds_ = ADSL)

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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 SUBPOSITION IN VARIABLE NAME

OBSERVATION OBSERVATION
1 STUDYID

2 USUBJID

3 SITEID

4 1 SITEGR*

4 2 SITEGR*N

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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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ADaM 2.1 – ANALYSIS VARIABLE METADATA

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

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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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AGENDA

Reference

Introduction

ADaM 2.1: CRO perspective

Conclusion

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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

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QUESTIONS ?
E-mail: tineke.callant@sgs.com
www.sgs.com/cro

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