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Loading of Central Lab Data in CDISC LAB Standard. Kurt Hellstern. Hands-on GmbH. Central Lab Database. Tabulator. SDTM. ODM. LAB (xml). Dataflow. Steps to Be Performed. Write specifications for the lab system extract file - PowerPoint PPT Presentation
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Loading of Central Lab Datain
CDISC LAB Standard
Kurt Hellstern
Hands-on GmbH
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Dataflow
LAB
(xml)
ODM SDTMTabulator
Central Lab
Database
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Steps to Be Performed
1. Write specifications for the lab system extract file
2. Define new MARVIN metadata: One ItemGroup per lab parameter
3. Lab Data Loader by XClinical
4. Load test file
5. Correction loop if necessary: restart at step 1
6. Implement process and go live
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Step 1: Extract File Specifications
Use the specifications from the CDISC web page / standards
Download the Excel version of the specifications
Edit the specification files according to the study‘s needs:
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Step 1: Extract File Specifications (2)
Detail: parameter names
CDISCcontrolled
terminology
Detail: visit names
Will be used in SDTM
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Step 2: New MARVIN Metadata
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Step 3: Load Process to Be Prepared
Central Lab
MARVIN
Sftp/scp-Server
XSLT-Transformation(Batch job)
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Step 4-6: Load File
Data fields used for linking and verifying between load file and MARVIN(selection)
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Did it work?
Step 6: Completed Task
Yes, we can!
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One Itemgroup per Parameter
All entries protected against changes – except
“Evaluation” in case of alerts not equal “N”
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Problem Report
„Non-Matching“ report at each loading