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changes.mady.by.user Sally Cassells

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changes.mady.by.user Lex Jansen

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Flatter representation.

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

Align with FHIR.

AttributeSchema Datatype or Enumeration
Usage
Definition
/Business Rules
OIDoidNamenameType(Sponsor | Site | CRO | Lab | Other | TechnologyProvider)LocationOIDPartOfOrganizationOIDoidref(optional)

Contained in:

...

The user's organization. Can e.g. be a sponsor organization, a CRO, an EDC vendor organization. The PartOfOrganizationOID attribute references a parent organization of which the described organization is a part of, when applicable. The location defines the MetaDataVersion.

The physical location 

a physical location which address may deviate from the information provided in the Address child element.
An organization can have different roles and can be of different types.

...

  • Business Rule(s):
    • There must be an ItemDef element for each unique ItemOID attribute value in the study.