ODM
From Clinfowiki
Revision as of 13:57, 20 July 2015 by Vojtech huser (Talk | contribs)
Operational Data Model is a CDISC standard for communicating eCRFs, study data and study metadata.
ODM Examples
- 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
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