07-23-2012 06:16 AM
I have a question regarding the mapping and conversion of ODM v1.3 to SDTM v3.1.2.
Is there an easy way to convert ODM-Files, extended with SDS-VarNames and Aliases, to valid SDTM-datasets using SAS 9.3 and the Clinical Standards Toolkit 1.4?
Does anyone have experiences on that?
Thank you very much for any help regarding this issue.
07-23-2012 01:40 PM
Direct support for the functionality to convert ODM files to SDTM data sets is not available in Clinical Standards Toolkit 1.4.
In SAS Clinical Standards Toolkit version 1.5, limited support of extraction of ODM data into SAS domain-based data sets is planned, however the planned functionality may not support the level of conversion ODM to SDTM data sets that you describe. Mapping and transformation of patient data from one CDISC standard to another is generally managed through the use of SAS Clinical Data Integration. SAS Clinical Data Integration provides wizards for running the SAS Clinical Standards Toolkit macros, metadata-driven mapping via a graphical interface, metadata and data standards management, as well as an integration with Medidata Rave via web services and ODM. This integration provides a process similar to what you describe: Take incoming ODM metadata and data (either snapshot or transactional), transform the data into one or more SAS data sets, map that data into an existing data standard like CDISC SDTM, check the resulting tables against the data standard, and create the CRT-DDS documentation file (define.xml/define.pdf).
If you would like to receive and evaluate a pre-production release of the SAS Clinical Standards Toolkit 1.5 ODM-extraction utility as part of our early adopter program, or if you wish to discuss related SAS Clinical Data Integration capabilities, please contact me, Bill Gibson (billj.gibson<at>sas.com).