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

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

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

6. Step 2: New MARVIN Metadata

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

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

9. Step 6: Completed Task
Did it work?
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