Body:
| (AuditRecord?, Signature?, InvestigatorRef?, SiteRef?, Annotation*, StudyEventData*) |
Attributes:
| SubjectKey | subjectKey | ||
| TransactionType | (Insert | Update | Remove | Upsert | Context) | (optional) | The TransactionType attribute need not be present in a Snapshot document. |
Contained in:
Clinical data for a single subject.
The SubjectKey is used to identify a specific subject. This key uniquely identifies a subject within the study specified by the parent ClinicalData element. If the same SubjectKey is used in multiple ClinicalData elements in a single study, this is interpreted as being the same subject.
Example:
<ClinicalData StudyOID="P2006-101" MetadataVersionOID="101.01">
<SubjectData SubjectKey="1000" TransactionType="Insert">
<StudyEventData StudyEventOID="Screen">
<FormData FormOID="DEMOG">
<ItemGroupData ItemGroupOID="DM">
<ItemDataString ItemOID="USUBJID">101-001-001</ItemDataString>
<ItemDataString ItemOID="SEX">F</ItemDataString>
</ItemGroupData>
</FormData>
<FormData FormOID="LABDATA">
<ItemGroupData ItemGroupOID="LB">
<ItemDataDatetime ItemOID="LBDTC">2006-07-14T14:48</ItemDataDatetime>
<ItemDataString ItemOID="LBTESTCD">ALT</ItemDataString>
<ItemDataString ItemOID="LBORRES">245</ItemDataString>
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
<ClinicalData StudyOID="P2006-101" MetadataVersionOID="101.02">
<SubjectData SubjectKey="1000" TransactionType="Insert">
<StudyEventData>
<FormData FormOID="AENONSER">
<ItemGroupData ItemGroupOID="AE">
<ItemDataString ItemOID="AETERM">Fever</ItemDataString>
<ItemDataDate ItemOID="AESTDTC">2006-08-21</ItemDataDate>
</ItemGroupData>
</FormData>
<FormData FormOID="LABDATA">
<ItemGroupData ItemGroupOID="LB">
<ItemDataDatetime ItemOID="LBDTC">2006-07-14T14:48</ItemDataDatetime>
<ItemDataString ItemOID="LBTESTCD">ALT</ItemDataString>
<ItemDataString ItemOID="LBORRES">300</ItemDataString>
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>