ODMSubmit

The top-level element of an ODM document. The ODMSubmit element has several defined sub-elements, but only ClinicalData is supported for the InForm ODM format.

Example

<ODMSubmit Description="Depression Study" FileType="Transactional"

pf:HierarchicalOIDs="Yes"

xmlns="http://www.cdisc.org/ns/odm/v1.3"

xmlns:pf="http://www.phaseforward.com/InFormAdapter/ODM/Extensions/2.0">

<ClinicalData … details omitted

Supported sub-elements

ClinicalData—Optional.
Zero or more instances.

Supported attributes

ODMVersion—Required.
ODM version number. Must be 1.3.1.
FileType—Required.
Type of the file. Must be Transactional.
FileOID—Required.
Uniquely identifies each distinct ODM bit.
PriorFileOID—Optional.
Allows you to uniquely order ODM bits.

The specified PriorFileOID must match the FileOID of an ODM bit that was previously processed. If it does not, the submit action fails.
CreationDateTime—Required but is not used by the Clinical Data API.
Date and time of creation.
pf:HierarchicalOIDS—Required.
Must be Yes.

Unsupported elements

AdminData
ReferenceData
Study

Unsupported attributes

Archival
AsOfDateTime
Association
Description
Granularity
Id
Originator
SourceSystem
SourceSystemVersion
pf:InFormAdapterVersion
pf:MappingVersion