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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
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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 • 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
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:
Detail: visit names Detail: parameter names Step 1: Extract File Specifications (2) Will be used in SDTM CDISC controlled terminology
MARVIN Step 3: Load Process to Be Prepared Central Lab Sftp/scp-Server XSLT-Transformation (Batch job)
Step 4-6: Load File Data fields used for linking and verifying between load file and MARVIN (selection)
Did it work? Step 6: Completed Task Yes, we can!
One Itemgroup per Parameter All entries protected against changes – except “Evaluation” in case of alerts not equal “N”
Problem Report „Non-Matching“ report at each loading
Thank you kurt.hellstern@hands-on.ch