SubjectStatus element

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SubjectStatus element

The SubjectStatus element indicates that a state change has occurred to a patient, subject, or CRB.

XPath

ODM/ClinicalData/SubjectData/pf:SubjectStatus

SubjectStatus elements

Parent element

Child element

SubjectData

odm:AuditRecord.

Attributes

SubjectStatus attributes

Attribute

Description

Frozen

A flag that indicates whether the subject is frozen.

type=odm:YesOrNo.

Optional.

Locked

A flag that indicates whether the item is locked.

type=odm:YesOrNo.

Optional.

SVReady

A flag that indicates whether the item is source verification ready.

type=odm:YesOrNo.

Optional.

State

The state of the subject. Values are: Screened, ScreenFailed, Enrolled, EnrollmentFailed, EnrollmentOverride, Randomized, Complete, or DroppedOut.

type=SubjectState.

Optional.

ScreenFailReason

The reason that the subject failed the screening.

type=xs:string.

Optional.

EnrollFailReason

The reason that the subject failed to enroll.

type=xs:string.

Optional.

EnrollOverrideReason

The reason that the enrollment was overridden.

type:xs:string.

Optional.

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