SubjectData

Attributes Value/Map to Oracle InForm
SubjectKey Patient DBUID
GUID Subject identifier
Revision

Entity: Subject

Property: Revision

SiteRef

Entity: Patient Move

Property: no property listed.

CriticalItems

Includes a separate CriticalItem element for each item-level change that occurs in the Oracle InForm application.

For more information, see CriticalItem.

Signature

Indicates that the CRB has been signed for the subject.

SiteRef

Site for the subject. In the event of a subject site move, a SubjectData element that contains a new SiteRef and no StudyEventData element is sent.

pf:SubjectPool

Represents the source verification pool in the InForm application.

SubjectData/pf:SubjectPool

Attributes Value/Map to Oracle InForm
PoolNumber

The Oracle InForm Pool Number.

type=xs:string.

Required.

One of the following values, representing the available pools that are hardcoded in the InForm software:

0—PF_SVELIGIBLE_POOL

1—PF_SVAUTO_SELECT_POOL

2—PF_SVMANUAL_FIRSTN_POOL

3—PF_SVMANUAL_UISELECT_POOL

4—PF_SVMANUAL_IMPORT_POOL

99—PF_SVEXCLUDED_POOL

PoolRefName

The ref name of the pool.

type=xs:string.

Required.

One of the following values:

Eligible—PoolNumber=0, indicating the pool is SV Eligible.

AutoSelect—PoolNumber=1, indicating a pool whose members are automatically selected based on settings determined by the site administrator.

ManualFirstN—PoolNumber=2, indicating a pool in which the first <n> number of subjects are automatically selected.

ManualUISelect—PoolNumber=3, indicating that the pool members are added by being selected in the UI.

ManualImport—PoolNumber=4, indicating an imported file that contains the pool members.

Excluded—PoolNumber=99, indicating that the pool is excluded from source verification.

pf:SubjectPoolChange

Reflects the change in the subject pool. Includes the subjects placed in the pool.

SubjectData/pf:SubjectPoolChange

Attributes Value/Map to Oracle InForm
LocationOID Includes the subjects placed in the pool.
PoolNumber Pool number

pf:CriticalForm

Represents a form that must be source verified.

SubjectData/pf:CriticalForm

Attributes Value/Map to Oracle InForm
FormRef FORMGUID
LocationOID Site OID
IsCritical ISCRITICAL

pf:ReviewState

Represents the state and stage of the progress of data review in the Oracle InForm application.

SubjectData/pf:ReviewState

Attributes Value/Map to Oracle InForm
pf:DBUID DBUID
RefName Review state name
StateValue State value
Revision Revision number
Name element Translated text
Mnemonic element Mnemonic

pf:ReviewStage

Represents one of the three review stages of the review state.

SubjectData/pf:CriticalForm

Attribute Map to Oracle InForm
RefName Stage ref name
StageValue Stage value
Activated 0 or 1
Revision Revision number

Example

<ClinicalData StudyOID="StudyDesign" MetaDataVersionOID="Study Design 0.0.2"
      pf:TransactionGuid="{6EAEA8C3-68D1-4314-881C-5AA2A5575308}"
      pf:Revision="326048162773035.000"><SubjectData SubjectKey="14266" TransactionType="Upsert"
      pf:GUID="{83A9C428-8475-4AEF-A169-37D4F1E52975}"><SiteRef LocationOID="13341" /><StudyEventData StudyEventOID="enroll"><AuditRecord><UserRef UserOID="enes" /><LocationRef LocationOID="Unknown" /><DateTimeStamp>2011-05-02T21:56:02+00:00</DateTimeStamp><ReasonForChange>Visit Started</ReasonForChange></AuditRecord><FormData FormOID="frmEnr"><ItemGroupData ItemGroupOID="frmEnr.sctSubjectNum"><ItemData ItemOID="frmEnr.sctSubjectNum.SubNum_Enr.SubNum_Enr" Value="AAA"><AuditRecord><UserRef UserOID="enes" /><LocationRef LocationOID="13341" /><DateTimeStamp>2011-05-02T21:56:02+00:00</DateTimeStamp><ReasonForChange>Enrollment Entry</ReasonForChange><SourceID>RDINFAPP261</SourceID></AuditRecord></ItemData></ItemGroupData></FormData></StudyEventData></SubjectData></ClinicalData>