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changes.mady.by.user Sally Cassells

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

Body:

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness RulesOIDoidRequiredBusiness Rules?, OrganizationRef, LocationRef*, Certificate (Deprecated*)
FullName?, GivenName?, FamilyName?, Image?, Address*, Telecom*)

Attributes:

Usage/Business Rules
  • Business Rule(s):
    • For each UserRef/@UserOID value in an AuditRecord or Signature element in the Clinical Data
there 
    • , there must be a User element with a matching OID attribute
.UserType(Sponsor | Investigator | Subject | Monitor | Data analyst | Care provider | Assessor | Lab | Other)OptionalUser'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 OrganizationDef elment.Must match the OID attribute for an OrganizationDef element within this AdminData element.

Contained in:

...

Information about a specific user of a clinical data collection or data management system. This may be an investigator, a research subject, a care provider,  a study monitor,  data management  or data analytics staff. A user can be a member of more than one organization,  work  or enter data at different locations.  In the case of studies that include patient reported outcomes, the user may be a study subject and/or their care-giver.

...