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What is ODM?
ODM is an XML format developed by CDISC for exchanging and archiving clinic trial data. The i2b2 import tool allows for importing all ODM version 1.3 files from a given directory into an i2b2 database.
While ODM is vendor-independent in theory, mapping of the internal data models from different CDMS might lead to slightly different ODM 'shapes' in practice. The import tool was tested with:
- SecuTrial 4.6
- OpenClinica 3.0-3.4
Example Files
CDISC-ODM Sample The CDISC Operational Data Model (ODM), maintained by the CDISC XML Technologies Team, is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor neutral, platform-independent format for interchange and archive of clinical study data. The model includes clinical data along with its associated metadata, administrative data, reference data and audit information. All the information that needs to be shared among different software systems during the study setup, operation, analysis, submission or for long-term retention as part of an archive is included in the model. See details on the CDISC ODM certification program, including a list of ODM-certified company products.
Example File
Import CSDISC-ODM
To import your CDISC-ODM files to i2b2, you have to select the i2b2 project in the Import Browser
