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The XML4Pharma CDISC ODM Generator

Generate CDISC ODM files from "flat" data files such as CSV, bar-delimited and Excel exports

Download the User Manual.

The problem

Although the CDISC ODM Standard is THE standard for the exchange of clinical data and metadata, we observe that "flat" data files, such as CSV files, bar-delimited data files and exports from Excel worksheets are still used in our industry. An example is where laboratories send the data as simple text files with field delimited by a comma or semicolon, or a vertical bar.
As there is a high variety in such data files, each type requires different software and methods to work with it. As such, we have decided to not support all possible variations in our popular SDTM-ETL software, but instead provide a tool that allows users to transform such "flat" data files into CDISC ODM.

The solution

Our "ODM Generator" allows to load "flat" data files, where data fields are separated by a delimiter.


Once a data file loaded, the system can generate a proposal for the metadata, which is derived from the data itself. The generated table with the metadata can then be edited by the user.


and saved to file for later reuse.
Fields can be assigned an ODM-OID, an ODM name, and the data type and maximal field length can be changed. This needs to be done only once for each distinct file type (e.g. company-internal standard), and can then be reused many times to generate the ODM files with captured data.
Fields can also be selected or filtered out to appear in the final ODM.
When applicable, fields can be assigned that represent the subject ID, the visit (ODM "StudyEvent") and possibly a target form in the EDC system. The system will then use this information for the organization of the ODM documents.

An example of such a complete mapping/assignment is given below:



When then clicking the "Export as ODM" button, the loaded "flat" data file will be transformed into a valid and well-organized CDISC ODM file, which can then e.g. be used as input in our SDTM-ETL software.

The generated ODM metadata can also be further extended (e.g. addition of codelists, CRF information, ...) using the "ODM Study Designer" software.

Product information

Very detailed information is available in the User Manual.

Licensing

The ODM Generator software is free of charge when purchasing at least 2 SDTM-ETL licenses, and comes at a reduced price when only 1 SDTM-ETL license is purchased.
If you would like to purchase a license for other purposes than in combination with SDTM-ETL, please contact us for a quotation.


Contact XML4Pharma
XML4Pharma, Katzelbachweg 18, 8052 Thal, Austria