Setting the Scene Study 1 PI/ Study 2 Study 3- II PIII CRO - - PowerPoint PPT Presentation

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ICON CD04 - Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies an ICON Approach Jennie Mc Guirk 11 th October 2011 Setting the Scene Study 1 PI/ Study 2 Study 3- II PIII CRO Integrated Study 2 Custom

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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

Study 1 – PI/ II Study 1 Study 2 Integrated Study 2 – PIII Study 3- CRO

Value Level?? Custom Domains?? Supplemental Values?? Controlled Terminology??

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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

Study1 SDTM Datasets

Annotated CRF SDTM specification

Data Warehouse

Define File Metadata

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Data Warehouse Build – multiple studies

aCRF SDTM Spec

Data Warehouse Study 1

aCRF SDTM spec

Study 2

aCRF SDTM spec

Study 3

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

Study 1 Study 1 Study 2 Study 3 Study 2 Study 3

Value Level

Integrated

Custom Domains Supplemental Values Controlled Terminology

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Conclusion

Effective Tool for individual / large scale projects
Benefits

– Efficient Data Integration – Report runs on individual study data -> no need for integration – ICON developed SAS tool ->Low 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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