ODM
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Revision as of 19:29, 10 September 2015 by Vojtech huser (Talk | contribs)
Operational Data Model is a CDISC standard for communicating eCRFs, study data and study metadata.
ODM Examples
- Open Clinica ODM example file for importing form data into an EDC system https://community.openclinica.com/sites/fileuploads/akaza/cms-community/OC_Demo_Study.zip
- http://www.medical-data-models.org/forms/162 After registration, user can download any form in ODM. This form #162 includes links to coded terms in UMLS or ICD
- Example of ODM based form and patient data (from an informatics article) http://files.figshare.com/1726724/06_Raloxifene_Study_SurgicalFindingsFormWithData.ODM.xml
- full set of XML attachments is here http://figshare.com/articles/Protocol_Knowledge_Representation/1096216
- Example of an ODM file with many Study Data Model elements (LZZT trial) http://www.cdisc.org/system/files/members/standard/cdisc_sdm_xml_1.0__supporting_schemas__examples__and_references.zip
Possible suggestions for future versions of ODM
abbreviations: ClinicalTrials.gov registry (CTG)
- provide references (either by DOI, PMID, PMCID or URL)
- supporting reference (CTG field) If a study is done because some encouraging results, the supporting article is provided to justify the study
- result reference - (CTG field) if a study published results, this field captures the PMID of that article
- study type (CTG field) - field indicating if it is an interventional vs. observational study
- matrix question
- selecting 2+ inputs from a codelist
- assigning multiple values for one item (i.e. multiple select dropdown) is not possible. For example, OpenClinica bypasses this limitation, by using a string data type (and using a comma-separated list of selected values in the plain ODM export.) However this is leads to loss of data type.
