ICON Power Point Template

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ICON CD04 - Ensuring Compliant and Consistent
Data Mappings for SDTM-based Studies an ICON
Approach Jennie Mc Guirk 11th October 2011
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Setting the Scene
Custom Domains??
Value Level??
Controlled Terminology??
Supplemental Values??
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An ICON Approach

• Compliancy single study
• Independent Review / Interpretation of IG
• Validation methodologies (e.g. Double
  programming)
• Integrity Checks
• WebSDM
• OpenCDISC
• Define Checker
• Consistency multiple studies
• Data Warehouse Tool

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Data Warehouse Build single study
Define File
Metadata
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Data Warehouse Build multiple studies
Metadata
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Data Warehouse Reports

• 7 Reports
• Report 1 Summary of Domain Distribution by
  Study.
• Report 2 Summary of Variable Distribution by
  Study.
• Report 3 Summary of Variable Values by Study.
• Report 4 SDTM Pairing of Test Code and Test
  Name.
• Report 5 SDTM Extended Paired Variables.
• Report 6 SDTM Nested Variable Values.
• Report 7 CRF Page Number Comparisons.

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Data Warehouse - Report 1

• Summary of Domain Distribution by Study

Consistency of Custom Domain Names
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Data Warehouse - Report 2

• Summary of Variable Distribution by Study

QNAM
QLABEL
Consistency of Supplemental Variable Values
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Data Warehouse - Report 3

• Summary of Variable Values by Study

VALUE
Consistency of Value Level
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Data Warehouse - Report 4

• SDTM Pairing of Test Code and Test Name

--TESTCD
--TEST
Consistency of Extensible Controlled Terminology
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Data Warehouse - Report 5

• SDTM Extended Paired Variables

--TESTCD
--TEST
--STRESU
--CAT
Consistency of Paired Variables
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Data Warehouse - Report 6

• SDTM Nested Variables

--TESTCD
--TEST
--CAT
--SPEC
Consistency of Nested Variables
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Data Warehouse - Report 7

• CRF Page Number Comparisons

Consistency of aCRF and Define File
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Conclusion
Integrated
Supplemental Values
Value Level
Custom Domains
Controlled Terminology
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Conclusion

• Effective Tool for individual / large scale
  projects
• Benefits
• Efficient Data Integration
• Report runs on individual study data -gt no need
  for integration
• ICON developed SAS tool -gtLow cost to create
  maintain
• Harmonisation as new studies introduced to drug
  program
• Harmonisation as company standards or IG evolves
• Code reuse - SDTM, ADaM and TLGs
• Aid Heath Authority Review
• Current Enhancement
• Adding filtering to just highlight
  inconsistencies
• Future Enhancement
• Add further reports / checks as required

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Acknowledgements

• Co-author Steven Thacker
• Tool Developer Annie Gou

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Ensuring Compliant and Consistent Data Mappings
for SDTM-based Studies an ICON Approach
?