ODM

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.

• • • https://github.com/OpenClinica/OpenClinica/tree/master/core/src/main/resources/properties