Loading of Central Lab Data

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Presentation transcript:

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

Dataflow Central Lab Database ODM SDTM Tabulator LAB (xml)

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:

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

Step 2: New MARVIN Metadata

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

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

Step 6: Completed Task Did it work? 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