Roche Global Data Standards Repository (GDSR)... and how the Clinical Programmers work with it Antje...
-
Upload
esmond-mcdaniel -
Category
Documents
-
view
233 -
download
0
Transcript of Roche Global Data Standards Repository (GDSR)... and how the Clinical Programmers work with it Antje...
![Page 1: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/1.jpg)
Roche Global Data Standards Repository (GDSR)... and how the Clinical Programmers work with it
Antje Rossmanith, Roche14th German CDISC User Group, 25-Sep-2012
![Page 2: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/2.jpg)
Overview
1. SDTM programming framework at Roche
2. Global Data Standards Repository (GDSR) browser
3. Data Tabulation Extract Excel spreadsheet
4. LB mapping
5. Conformance check tool
![Page 3: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/3.jpg)
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.)
![Page 4: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/4.jpg)
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
![Page 5: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/5.jpg)
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
![Page 6: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/6.jpg)
2. Global Data Standards Repository (GDSR) browser (2)
![Page 7: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/7.jpg)
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
![Page 8: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/8.jpg)
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
![Page 9: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/9.jpg)
4. LB mapping (2)Lab Standards table
![Page 10: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/10.jpg)
4. LB mapping (3)Preferred units table
![Page 11: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/11.jpg)
4. LB mapping (4)Unit Conversions table
Conversions independent from Lab parameter
Conversions depending on Lab parameter
![Page 12: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/12.jpg)
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
![Page 13: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/13.jpg)
Any questions?
![Page 14: 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.](https://reader035.fdocuments.in/reader035/viewer/2022081506/56649e575503460f94b4f48f/html5/thumbnails/14.jpg)
We Innovate Healthcare