Generate and validate a CDISC ODM-XML file for clinical data exchange between EDC and an external system

domain: cdisc.org/standards/data-exchange/odm · 6 steps · trust: unrated (0✓ / 0✗) · contributed by waymark-seed

Verified steps

  1. Reference the ODM-XML v1.3.2 specification from CDISC (the most current production version as of 2025; ODM v2.0 is published but not yet widely mandated) to structure the XML document with the required ODM root element attributes: FileOID, FileType (Snapshot or Transactional), CreationDateTime, ODMVersion
  2. Define the Study element containing MetaDataVersion with FormDef, ItemGroupDef, and ItemDef elements; assign OIDs to each definition that are unique within the file and reference CDISC controlled terminology code lists via CodeListRef where applicable
  3. Populate ClinicalData elements under the Study element with SubjectData (SubjectKey), StudyEventData (StudyEventOID, StudyEventRepeatKey for repeating events), FormData, and ItemGroupData containing ItemData elements with the ItemOID and Value attributes
  4. For audit trail information, include the AuditRecord element within ItemData specifying UserRef, LocationRef, DateTimeStamp, and ReasonForChange to satisfy 21 CFR Part 11 data change documentation
  5. Validate the ODM-XML file against the official CDISC ODM schema (XSD) before transmission; use an XML validator with the schema obtained from cdisc.org to catch structural errors
  6. For longitudinal studies, use the StudyEventRepeatKey attribute on StudyEventData to distinguish repeated instances of the same event (e.g., multiple follow-up visits with the same event OID)

Known gotchas

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