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Efficient Loading of Central Lab Data in CDISC LAB Standard

Learn the step-by-step process to load central lab data in CDISC LAB standard using MARVIN metadata and Lab Data Loader by XClinical. Extract file specifications, define metadata, load test files, verify data, and implement the process for efficient data loading. Stay updated with SDTM CDISC controlled terminology.

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Efficient 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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