1 Loading of Central Lab Data in CDISC LAB Standard Kurt Hellstern Hands-on GmbH.
-
Upload
doreen-carter -
Category
Documents
-
view
217 -
download
3
Transcript of 1 Loading of Central Lab Data in CDISC LAB Standard Kurt Hellstern Hands-on GmbH.
1
Loading of Central Lab Datain
CDISC LAB Standard
Kurt Hellstern
Hands-on GmbH
2
Dataflow
LAB
(xml)
ODM SDTMTabulator
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
CDISCcontrolled
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