How to Build ADaM Basic Data

Structure from Mock Up tables

By Kevin Lee
Cytel, Inc.

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 Instruction of Basic Data Structure
ƒ BDS is the standard domain structure in ADaM.
ƒ BDS is designed as one or more records per subject
per analysis parameter per analysis time point.
ƒ One of the main purposes of ADaM BDS is analysis-
ready, meaning that all the numbers in the final
report should be calculated with one procedure in
SAS.
ƒ The naming convention of BDS is ADxxxxxx.

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 BDS Structure

ƒ Subject Identifier Variables

ƒ Treatment Variables
ƒ Timing Variables
ƒ Analysis Parameter Variables
ƒ Analysis Descriptor Variables
ƒ Indicator Variables
ƒ Analysis Enabling Variables
ƒ Data Point Traceability Variables
ƒ SDTM Variables

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Steps to create ADaM BDS from Mock Up tables

ƒ Design Mock Up Tables (typically created by

Statistician) according to SAP
ƒ Annotate Mock Up Tables
ƒ Design Metadata according to Mock Up
Tables
ƒ Create ADaM BDS data sets according to
Metadata

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 Flowchart

SAP Mock Up tables

Annotated
Metadata
Mock Up tables

SDTM ADaM TFL

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 Mock Up table
Table 14.4.1
Summary of table of Creatine at baseline
(Per Protocol Population)

Group 1: Group 2:
Treatment 1 Placebo
(N=xxx) (N=xxx)
n Mean n Mean
Observed Observed
Value Value
Creatine

Log of
Creatine

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 Annotated Mock Up table
Table 14.4.1
Summary of table of Creatine at baseline ADLB.AVISIT=‘BASELINE’
(Per Protocol Population) ADLB.PPROTFL=‘Y’

Group 1: Group 2:
Treatment 1 Placebo
(N=xxx) (N=xxx)
ADLB.TRTAN = 1 ADLB.TRTAN = 2
n Mean n Mean
Observed Observed
Value Value
Creatine Count( MEAN(ADL Count MEAN(ADLB.
where ADLB. ADLB. B.AVAL) (ADLB AVAL)
PARAMCD=‘CREAT’ AVAL) .AVAL)
Log of Creatine
where ADLB.
PARAMCD=‘L10CREAT’

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New Variables according to annotation
ƒ Protocol population variable – PPROTFL
ƒ Baseline – AVISIT, AVISITN
ƒ Treatment variable – TRTAN, TRTA
ƒ Parameter Variable – PARAM, PARAMCD
ƒ Observed Mean Value Variable – AVAL
New Parameters according to annotation
ƒ Creatine – Its paramcd is “CREAT” and its analysis
values, AVAL, come from LB.LBSTRESN.
ƒ Log of Creatine – Its paramcd is “L10CREAT” and
its analysis values, AVAL, come from log of
LB.LBSTRESN.

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Analysis Dataset Metadata
Dataset Dataset Dataset Dataset Key Class of Documentation
Name Description Location Structure variables Dataset
of
Dataset
ADLB Laboratory ADLB.xpt one record USUBJID, BDS ADLB.SAS
analysis per subject PARAM,
data per AVISIT
parameter
per
analysis
timepoint

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Analysis Variable Metadata including Analysis
Parameter Value-Level Metadata
Parameter Variable Variable Type Format Codelist/ Source/
Identifier Name Label Controlle Derivation
d Term
Subject Identifier Variables
** ALL ** STUDYID Study Char $12. ADSL.STUDYID
Identifier
** ALL ** ADDOMAIN Analysis Char $8. ADLB Derived
Domain
** ALL ** USUBJID Unique Char $20. LB.USUBJID
Subject
Identifier
** ALL ** SUBJID Subject Char $8. ADSL.SUBJID
Identifier for
the Study
** ALL ** SITEID Study Site Char $10. ADSL.SITEID
Identifier

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Parameter Variable Variable Type For Codelist/Contr Source/
Identifier Name Label mat olled Term Derivation

Treatment Variables
** ALL ** TRTA Actual Char $20. ADSL.TRTA
Treatment
Group
** ALL ** TRTAN Actual Num 8. ADSL.TRTAN
Treatment
Number
Timing Variables

** ALL ** AVISIT Analysis Char $50. BASELINE LB.VISIT

Timepoint VISIT 1
Description
** ALL ** AVISITN Analysis Num 8. 0 = BASELINE LB.VISITNUM
Timepoint 1 = VISIT 1
Number

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Parameter Variable Variable Label Type Form Codelist/C Source/
Identifier Name at ontrolled Derivation
Term
Analysis Parameter Variables
CREAT PARAM Parameter Char $100. Creatine( LB.LBTESTCD
Description mg/dL) + unit
L10CREAT PARAM Parameter Char $100. Log of LB.LBTESTCD
Description Creatine( + unit
mg/dL)
** ALL ** PARAMCD Parameter Code Char $8. CREAT LB.LBTESTCD
L10CREAT
L10CREAT PARAMTYP Parameter Type Char $8. DERIVED
CREAT AVAL Analysis Value Num 8. LB.LBSTRESN
L10CREAT AVAL Analysis Value Num 8. Log10(LB.LBST
RESN)

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Parameter Variable Variable Label Type For Codelist/Co Source/
Identifier Name mat ntrolled Derivation
Term
Indicator Variables
** ALL ** PPROTFL Per Protocol Char $1. ADSL.PPROT
Population Flag FL
** ALL ** ABLFL Baseline Flag Char $1. ‘Y’ at
ADLB.AVISIT=
‘BASELINE’
Supportive Variables
** ALL ** SRCDOM Source Domain Char $8. LB

** ALL ** SRCVAR Source Variable Char $8. LBSTRESN

** ALL ** SRCSEQ Source Sequence Num 8. LB.LBSEQ

Number

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Other Possible Variables
ƒ Analysis Parameter Variables - BASE, CHG
ƒ Analysis Descriptor variables – DTYPE
ƒ Categorical variables - CRIT1 and CRIT1FL
ƒ Indicator variables - ANL1FL
Sample codes using ADaM data set
proc sql;
**** The Count for and Mean value for Creatine and log of Creatine for
protocol population at Baseline;
create table line1_1 as
select trtan, paramcd, count(aval) as count, mean(aval) as mean
from adlb
where paramcd in (‘CREAT’, ‘L10CREAT’) and avisit = ‘BASELINE’
and pprotfl = ‘Y’ and aval is not missing
group by trtan, paramcd;
quit;

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Advantages using Annotated Mock Up tables
ƒ Easy to create the metadata
ƒ Analysis Dataset metadata
ƒ Analysis Variable metadata
ƒ Analysis Parameter Value-level metadata
ƒ Analysis Results metadata
ƒ Easy to explain
ƒ Easy for SAS programmers to follow
ƒ More visual
ƒ More accurate number of ADaM data sets

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Conclusion
ADaM is structured as analysis-ready. In order to build
analysis-ready ADaM data sets, SAS programmers need to
start from analysis, which are Mock Up tables. From Mock
Up tables, SAS programmers figure out what procedures
could be used for the analysis. Based on the procedure
statements and analyses, SAS programmers annotate the
Mock Up tables. The annotations on the Mock Up tables will
help SAS programmers to find out what variables are
needed in the analyses and eventually what variables and
parameters should be created in ADaM data sets. SAS
programmers now can create Metadata according to the
annotations. According to Metadata, SAS programmers can
create ADaM data sets from SDTM data sets. From ADaM
data sets, SAS programmers will be able to produce all the
results in the Mock Up tables using one proc procedure.

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Contact Information

Kevin Lee
Cytel, Inc.
Chesterbrook, PA
(610) 994 - 9840
Email:Kevin.lee@cytel.com

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