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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 Name | Organization |
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Parent Elements | AdminData |
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Element XPath(s) | /ODM/AdminData/Organization |
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Element Textual Value | None |
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Attributes | OID, Name, Role, Type, PartOfOrganizationOID, LocationOID |
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Child Elements | (Description?, Address*, Telecom*) |
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Usage/Business Rules | - Business Rule(s):
- There must be an ItemDef element for each unique ItemOID attribute value in the study.
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Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
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OID | oid | Required | Unique identifier for the organization. | - Must be unique within the Organization elements for a study.
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Name | name | Required | Formal, human readable name of the organization. | - Must be unique within the set of Organization elements for a study.
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Role | text | Optional | Role of the organization in the current study. |
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Type | (Sponsor | Site | CRO | Lab | Other | TechnologyProvider) | Required | Categorization of organizations associated with clinical studies. | - An ODM extension is required if additional Type values are needed.
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LocationOID | oidref | Optional | Reference 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.
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PartOfOrganizationOID | oidref | Optional | Reference to a parent organization. | - Must match the OID Organization within the study.
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