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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

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Thank you

kurt.hellstern@hands-on.ch