ODM

/ODM

• The ODM element is the root element of the document.
• Other Information: The whole document (but essentially each extensible element within the ODM document) can be signed off through an electronic signature (e.g., XAdES) by adding a suitable element as last element, such as ds:Signature in the namespace "http://www.w3.org/2000/09/xmldsig#".

Snapshot means that the document contains only the current state of the data and metadata it describes, and no transactional history. 

Transactional means that the document may contain more than one instance per data point. 

Query means the document contains only ClinicalData/Query elements. 

In a  Snapshot document ClinicalData may include only one instance per data point. For clinical data, TransactionType in a Snapshot file must either not be present or be Insert.

Use a Transactional document to send  the current state of the data and the full history of transactions, including AuditTrail elements. There may be more than one instance per data point. The most recent instance must reflect the data on the source system as of the datetime stamps provided in the CreationDatetime and AsOfDatetime attributes.

Use Query to provide Query information for a  ClinicalData in a separate accompanying SnapShot Clinical Data document.

Granularity is intended to give the sender a shorthand way to

Describes the scope of information in the document, for certain common types of documents.

All means the entire study;

Metadata means the Study/MetaDataVersion element;

AdminData and ReferenceData mean the corresponding elements;

AllClinicalData means all of the ClinicalData collected for the study.

SingleSite, means all of the Clinical Data for a single study site.

SingleSubject means all of the Clinical Data for a single Subject.

Indicates the intended usage of the ODM document. 

Archive - indicates that the file is intended to meet the requirements of an electronic record as defined in 21 CFR 11.  

Submission - indicates that the file is intended to be used for regulatory submission.

Exchange - indicates that the file was generated to be imported into an ODM compliant system.

If Context is not provided, the default value is Exchange.

FileType must be Transactional when Context is Archive. See Single Files and Collections for an fuller discussion of the use of the Archive Context and how it interacts with other ODM attributes. 

The AsOfDateTime is the latest date/time of any new or updated data in the ODM file. This attribute is implied, and if omitted, it is assumed that the AsOfDateTime is equal to the CreationDateTime. It is an error to supply an AsOfDateTime that is later than the CreationDateTime.

Pattern: 2.0(.(0|([1-9][0-9]*)))?(-([0-9a-zA-Z])+)*

Documents based on ODM 2.0 must have ODMVersion that starts with "2.0" in order to use the new features in this version. ODMVerson 2.0 is not backwards compatable with earlier ODM Versions.

These are examples of valid versions: 2.0, 2.0-R1, 2.0.1