Information about a specific user of a clinical data collection or data management system.

Element NameUser
Parent ElementsAdminData
Element XPath(s)/ODM/AdminData/User
Element Textual ValueNone
AttributesOID, UserType, OrganizationOID, LocationOID
Child Elements(UserName?, Prefix?, Suffix?, FullName?, GivenName?, FamilyName?, Image?, Address*, Telecom*)
Usage/Business Rules
  • Business Rule(s):
    • For each UserRef/@UserOID value in an AuditRecord or Signature element in the Clinical Data, there must be a User element with a matching OID attribute.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredBusiness Rules
  • For each UserRef/@UserOID value in an AuditRecord or Signature element in the Clinical Data there  must be a User element with a matching OID attribute.
UserType(Sponsor | Investigator | Subject | Monitor | Data analyst | Care provider | Assessor | Lab | Other)Optional

User's role in the study.

  • A user can be a member of more than one organization,  work  or enter data at different locations.
  • For studies that include patient reported outcomes, the user may be a study subject and/or their care-giver.
OrganizationOIDoidrefOptionalReference to an Organization elment.
  • Must match the OID attribute for an OrganizationDef element within this AdminData element.
LocationOIDoidrefOptionalReference to a Location element.
  • Must match the OID attribute for an OrganizationDef element within this AdminData element.

Example: User

User
<User OID="USR.007" UserType="Data analyst" OrganizationOID="ORG.MI6" LocationOID="LOC.MI6.LONDON">
    <UserName>James007</UserName>
    <Prefix>Mr</Prefix>
    <Suffix>VII</Suffix>
    <FullName>James Bond</FullName>
    <GivenName>James</GivenName>
    <FamilyName>Bond</FamilyName>
    <Image ImageFileName="Fleming007impression.jpg" MimeType="image/jpg" href="https://en.wikipedia.org/wiki/James_Bond#/media/File:Fleming007impression.jpg"/>
    <Address>
        <StreetName>Albert Embankment</StreetName>
        <HouseNumber>85</HouseNumber>
        <City>London</City>
        <Country>Great Britain</Country>
        <PostalCode>SE1 7FY</PostalCode>
        <OtherText>Vauxhall, Lambeth</OtherText>
    </Address>
    <Telecom TelecomType="Email" Value="James@MI6.org"/>
</User>

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