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

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

3 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

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: parameter names CDISC controlled terminology Detail: visit names Will be used in SDTM

6 Step 2: New MARVIN Metadata

7 Step 3: Load Process to Be Prepared Central Lab MARVIN 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