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An organization can rerference a parent organization. Users may be associated with an Organization. An Organization may be associated with a Location. A User, Location or Organization may have an address.

Element NameOrganization
Parent ElementsAdminData
Element XPath(s)/ODM/AdminData/Organization
Element Textual ValueNone
AttributesOID, Name, Role, Type, PartOfOrganizationOID, LocationOID
Child Elements(Description?, Address*, Telecom*)
Usage/Business Rules
  • Business Rule(s):
    • There must be an ItemDef element for each unique ItemOID attribute value in the study.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the organization.
  • Must be unique within the Organization elements for a study.
NamenameRequiredFormal, human readable name of the organization.
  • Must be unique within the set of Organization elements for a study.
RoletextOptionalRole of the organization in the current study.
Type(Sponsor | Site | CRO | Lab | Other | TechnologyProvider)RequiredCategorization of organizations associated with clinical studies.
  • An ODM extension is required if additional Type values are needed.
LocationOIDoidrefOptionalReference to a location where data is collected and/or study subjects are treated.
  • Must match the OID attribute for a Location element for the study.
PartOfOrganizationOIDoidrefOptionalReference to a parent organization.
  • Must match the OID Organization within the study.

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