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ICON Power Point Template

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Title: ICON Power Point Template Author: Julie Chalmers Last modified by: Trudy Turner Created Date: 10/18/2006 5:07:29 PM Document presentation format – PowerPoint PPT presentation

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Date added: 1 December 2019
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Tags: icon | point | power | template | tool

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Title: ICON Power Point Template


1
ICON CD04 - Ensuring Compliant and Consistent
Data Mappings for SDTM-based Studies an ICON
Approach Jennie Mc Guirk 11th October 2011
2
Setting the Scene
Custom Domains??
Value Level??
Controlled Terminology??
Supplemental Values??
3
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

4
Data Warehouse Build single study
Define File
Metadata
5
Data Warehouse Build multiple studies
Metadata
6
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.

7
Data Warehouse - Report 1
  • Summary of Domain Distribution by Study

Consistency of Custom Domain Names
8
Data Warehouse - Report 2
  • Summary of Variable Distribution by Study

QNAM
QLABEL
Consistency of Supplemental Variable Values
9
Data Warehouse - Report 3
  • Summary of Variable Values by Study

VALUE
Consistency of Value Level
10
Data Warehouse - Report 4
  • SDTM Pairing of Test Code and Test Name

--TESTCD
--TEST
Consistency of Extensible Controlled Terminology
11
Data Warehouse - Report 5
  • SDTM Extended Paired Variables

--TESTCD
--TEST
--STRESU
--CAT
Consistency of Paired Variables
12
Data Warehouse - Report 6
  • SDTM Nested Variables

--TESTCD
--TEST
--CAT
--SPEC
Consistency of Nested Variables
13
Data Warehouse - Report 7
  • CRF Page Number Comparisons

Consistency of aCRF and Define File
14
Conclusion
Integrated
Supplemental Values
Value Level
Custom Domains
Controlled Terminology
15
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

16
Acknowledgements
  • Co-author Steven Thacker
  • Tool Developer Annie Gou

17
Ensuring Compliant and Consistent Data Mappings
for SDTM-based Studies an ICON Approach
?
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