![Page 1: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/1.jpg)
1
Loading of Central Lab Datain
CDISC LAB Standard
Kurt Hellstern
Hands-on GmbH
![Page 2: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/2.jpg)
2
Dataflow
LAB
(xml)
ODM SDTMTabulator
Central Lab
Database
![Page 3: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/3.jpg)
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
![Page 4: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/4.jpg)
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:
![Page 5: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/5.jpg)
5
Step 1: Extract File Specifications (2)
Detail: parameter names
CDISCcontrolled
terminology
Detail: visit names
Will be used in SDTM
![Page 6: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/6.jpg)
6
Step 2: New MARVIN Metadata
![Page 7: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/7.jpg)
7
Step 3: Load Process to Be Prepared
Central Lab
MARVIN
Sftp/scp-Server
XSLT-Transformation(Batch job)
![Page 8: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/8.jpg)
8
Step 4-6: Load File
Data fields used for linking and verifying between load file and MARVIN(selection)
![Page 9: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/9.jpg)
9
Did it work?
Step 6: Completed Task
Yes, we can!
![Page 10: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/10.jpg)
10
One Itemgroup per Parameter
All entries protected against changes – except
“Evaluation” in case of alerts not equal “N”
![Page 11: Loading of Central Lab Data in CDISC LAB Standard](https://reader030.vdocuments.us/reader030/viewer/2022032612/56812cad550346895d915f08/html5/thumbnails/11.jpg)
11
Problem Report
„Non-Matching“ report at each loading