Root element.
| Element Name | ExternalCodeLib |
|---|---|
| Parent Element(s) | None |
| Element XPath(s) | /ODM |
| Element Textual Value | None |
| Usage | Required. Root element. |
| Attributes | FileType, Granularity, Context, FileOID, CreationDateTime, PriorFileOID, AsOfDateTime, ODMVersion, Originator, SourceSystem, SourceSystemVersion, Description, ID |
| Child Elements | (Study*, AdminData*, ReferenceData*, ClinicalData*, Association*, ds:Signature* |
Attributes:
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Attribute
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Schema Datatype or Enumeration
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Usage
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Definition
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Business Rules
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Body:
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Attributes:
Snapshot means that the document contains only the current state of the data and metadata it describes, and no transactional history. A Snapshot document may include only one instruction per data point. For clinical data, TransactionType in a Snapshot file must either not be present or be Insert.
Transactional means that the document may contain more than one instruction per data point. Use a Transactional document to send both what the current state of the data is, and how it came to be there.
Query means the document contains only ClinicalData/Query elements. It is intended to be used to provide Query information to accompany ClinicalData in a separate SnapShot Clinical Data document.
(Archive| Submission | Exchange)
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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. See Single Files and Collections for an fuller discussion of the meaning of this attribute, as well as its interaction with other ODM attributes. FileType must be Transactional when Context is Archive.
Submission - indciates that the file is intended to be used for regulatory submission.
DataExchange - indicates that the file was generated to be imported into an ODM compliant system.
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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.
The ODMVersion attribute was not defined in ODM 1.1, so a missing ODMVersion should be interpreted as "1.1".
Documents based on ODM 2.0 must have ODMVersion="2.0" set in order to use the new features in this version. Documents based on ODM 1.3.2 must have ODMVersion="1.3.2" set in order to use the new features in this version. Documents based on ODM 1.2.0 must have ODMVersion="1.2", documents based ODM 1.3.0 must have ODMVersion="1.3" and documents based on ODM 1.3.1 must have ODMVersion="1.3.1" for backwards compatibility purposes.
There is an extended discussion of these attributes in the section titled Single Files and Collections.
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