1. Antje Rossmanith, Roche 14th German CDISC User Group, 25-Sep-2012
Roche Global Data Standards Repository (GDSR) ... and how the Clinical Programmers work with it
Antje Rossmanith, Roche
14th German CDISC User Group, 25-Sep-2012

2. Overview SDTM programming framework at Roche
Global Data Standards Repository (GDSR) browser
Data Tabulation Extract Excel spreadsheet
LB mapping
Conformance check tool

3. 1. SDTM programming framework at Roche (1)
Source data from Rave Database available as SAS datasets
Programming framework for SDTM mapping
Excel Specification Templates
SAS Program Templates
Excel Controlled Terminology
SAS Macros (e.g. conversion into ISO8601, transposing, creating --SEQ variables, BL flags, etc.)

4. 1. SDTM programming framework at Roche (2)
Excel Specification Templates are defined with information from the GDSR
target domain definition (including Roche defined SUPPQUAL variables)
mapping rules from Roche standard source data to SDTM
Excel Controlled Terminology is built from the Controlled terminology in GDSR
contains CDISC submission values
contains mapping from source values to SDTM
used by the Clinical Programmer to create SAS formats

5. 2. Global Data Standards Repository (GDSR) browser (1)
If Roche standard data collection is used in a study, specification templates are used for SDTM mapping
Template development not ready yet
If no template available, GDSR browser is used to manually find the mapping rules

6. 2. Global Data Standards Repository (GDSR) browser (2)

7. 3. Data Tabulation Extract Excel spreadsheet
The GDSR content can be exported to an Excel Sheet
Advantage of the Excel export: target (SDTM domain) oriented, while browser is source oriented
Used to manually look up Value Level Metadata (e.g. LB, QS)
If no Excel Specification Template available, used to create Specification (target domain definition)
For outsourced studies: given to external vendors as reference for Roche implementation of CDISC, e.g. Sponsor defined domains, sponsor extension of Controlled Terminology, SUPPQUALs

8. 4. LB mapping (1)
Three Lab metadata tables from GDSR used for SDTM mapping
Lab Standards
Preferred Units
Unit Conversions
Set of SAS macros in the programming framework which access these tables and automate the mapping from the Roche code to SDTM
Tables are not accessed directly from GDSR, they are extracted on a regular basis as .CSV files into the programming area
New requests for Lab tests, units, conversions are submitted by the Clinical Programmer via a ticketing system and then added to the GDSR

9. 4. LB mapping (2) Lab Standards table

10. 4. LB mapping (3) Preferred units table

11. 4. LB mapping (4) Unit Conversions table
Conversions independent from Lab parameter
Conversions depending on Lab parameter

12. 5. Conformance check tool
In development - status: pilot is planned
Based on Open CDISC
Includes checks against CDISC standards and extended Roche standards in GDSR

13. Any questions?

14. We Innovate Healthcare