ODM

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Operational Data Model is a CDISC standard for communicating eCRFs, study data and study metadata.


ODM Examples

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