Case In Point
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Illustrating the point of a Statistical Controlled Environment and how Genzyme capitalizes on the metadata.
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Case In Point
- 1. Case in Point: The Point of a Statistical Controlled Environment and a Case Study or Alice vs. Billy the Kid - How the Metadata Wonderland Trumps the Wild Wild Legacy System Daniel Boisvert
- 3. There was a time when Statistical Computing was Free & Open
- 4. Wild Wild West Statistical Computing Framework Raw Data SDTM/ ADAM TLF Pgms. Final TLFs Delivery Dataset Pgms.
- 5. Wild Wild West Gaps SDTM Target AdaM specs TLF specs SAP Protocol Make files Multiple deliverables Raw Data SDTM/ ADAM TLF Pgms. Final TLFs Delivery Dataset Pgms. Draft TLF, Analysis Results Metadata Controlled Terminology, Value Level Metadata Define.xml
- 6. Point to Point Model Delivery Mgmt. TLF Specs QC Status File Share Manually Controlled by SOPs COTS ADAM Specs Draft Output Standard Macros Protocol,SAP, Final TLF EDMS Raw Data CDMS
- 7. Breakdowns Lead to Point Solutions Analysis Pgms. Standard Macros Make Files COTS Home Grown Software File Share Manually Controlled by SOPs VSS Draft Output Delivery Mgmt. QC Status TLF Spec ADAM Spec SDTM Target CDISC Metadata(VLM, ARM,CT) Protocol,SAP, Final TLF EDMS Raw Data CDMS
- 8. What is the Effect of a Change? Analysis Pgms. Standard Macros Make Files COTS Home Grown Software File Share Manually Controlled by SOPs VSS Draft Output Delivery Mgmt. QC Status TLF Spec ADAM Spec CHANGE SDTM Target CDISC Metadata(VLM, ARM,CT) Protocol,SAP, Final TLF EDMS Raw Data CDMS
- 9. Wild Wild West Workflow Programmer Makes Update Updates Spec Programmer reruns all TLF “just to be sure” Analysis Pgms. VSS Does this affect last weeks deliverable?
- 10. To anyone who can find out The Effect of the Change
- 14. WabanSCE Analysis Pgms. SDTM Target CDISC Metadata(VLM, ARM,CT) Standard Macros Make Files VSS Draft Output Delivery Mgmt. QC Status TLF Spec ADAM Spec Raw Data CDMS Protocol,SAP, Final TLF EDMS Metadata Wonderland
- 20. Wonderland Workflow CHANGE Automatic: ADSF goes “Stale” 1 table go “Stale” System knows what to rerun WabanSCE Metadata ADAM Spec Automatically Stale: ADSF 14.1.1.3
- 21. Impact Analysis
- 24. Biostats self reflection Query SCE Metadata Use Query Results How do we meet more aggressive Timelines? Improvment
Editor's Notes
- Replace this slide with a slide that shows the handoffs and the room for error that is created by the handoffs.
- Show workflow from silo to silo and how it is all people making the manual connections
- Our process works and works well, but the bar has been raised and we need to step up.
- Clear mapping between the plans for analysis, the tabulation data, the analysis data, and the analyses performed
- Hub and spoke model, one stop shopping