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Loading of Central Lab Data in CDISC LAB Standard

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

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Loading of Central Lab Data in CDISC LAB Standard

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  1. Loading of Central Lab Data in CDISC LAB Standard Kurt Hellstern Hands-on GmbH

  2. Central Lab Database Tabulator SDTM ODM LAB (xml) Dataflow

  3. Steps to Be Performed • Write specifications for the lab system extract file • Define new MARVIN metadata: One ItemGroup per lab parameter • Lab Data Loader by XClinical • Load test file • Correction loop if necessary: restart at step 1 • Implement process and go live

  4. 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:

  5. Detail: visit names Detail: parameter names Step 1: Extract File Specifications (2) Will be used in SDTM CDISC controlled terminology

  6. Step 2: New MARVIN Metadata

  7. MARVIN Step 3: Load Process to Be Prepared Central Lab Sftp/scp-Server XSLT-Transformation (Batch job)

  8. Step 4-6: Load File Data fields used for linking and verifying between load file and MARVIN (selection)

  9. Did it work? Step 6: Completed Task Yes, we can!

  10. One Itemgroup per Parameter All entries protected against changes – except “Evaluation” in case of alerts not equal “N”

  11. Problem Report „Non-Matching“ report at each loading

  12. Thank you kurt.hellstern@hands-on.ch

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