Considerations for ODM import in Oracle InForm studies
- Common visits—The ODM specification allows multiple
common StudyEventDefs, while Oracle Central Designer allows only one common visit.
All common StudyEventDefs in an ODM import file are consolidated into a single common visit after import. The forms defined for the common visits in the ODM import file appear in the single common visit in Oracle Central Designer.
The CommonVisit definition for the common visit that appears in Oracle Central Designer contains a LongTitle and ShortTitle, which are populated by the Description and Name defined in the first common StudyEventDef in the ODM import file.
- Units—The MeasurementUnit in the ODM import file is matched with entries in the Oracle Central Designer database based on unit symbols, but not unit names. If a unit in the ODM import file is not recognized as a unit in the Oracle Central Designer database, a warning message appears and the unit is not imported.
- Metadata—Oracle Central Designer does not recognize some ODM metadata (for example, the attribute SDSVarName). Any element or attribute in the ODM import file that is not recognized by Oracle Central Designer is ignored, and is not imported. You cannot recover this metadata after import.
- Rules—RangeCheck is the ODM simple range-checking attribute. Because the Oracle Central Designer application uses rules for range checking, ODM RangeChecks are imported as collaboration notes so that you can create the appropriate RangeCheck rules after importing.
- Import file type—Snapshot ODM represents a complete
picture of a study at a point in time. Transactional ODM represents the life
of the study over time. Oracle Central Designer supports standard ODM with a file type of Snapshot.
Oracle Central Designer does not support ODM file chaining. The ODM specification allows files to be chained together through the FileOID and PriorFileOID attributes. File chaining is primarily used in Transactional ODM, but can also be used in Snapshot ODM to break up study metadata into multiple files that are chained together. Transactional ODM uses file chaining to create a final end state of a study upon import completion. Because Oracle Central Designer does not support file chaining, if you import Transactional ODM, an error occurs.
Note:
You cannot import Oracle InForm metadata that you extracted from Oracle InForm Adapter with a Transactional file type. You must specify Snapshot as the file type parameter when you export data from Oracle InForm Adapter. For more information see the Oracle InForm Adapter User Guide. - Workflow—Because the OrderNumber attribute is optional
for StudyEventDefs in an ODM import file, the order in which the
StudyEventDefs appear in the ODM is the order in which they appear in the
Oracle Central Designer workflow.
- A study event with an OrderNumber attribute is assigned a sequence number, unless its predecessor in the workflow has a type of Scheduled.
- A study event with no OrderNumber attribute is placed at the end of the workflow, in the order in which it is read from the ODM import file.
Note:
Any study event, with or without an OrderNumber attribute, is assigned a sequence number of zero if its predecessor in the workflow has a type of Scheduled. - Localization—Oracle Central Designer imports localized data specified in an ODM import file. The translated
data appears in Oracle Central Designer in the language to which it was localized. For more information, see the
ODM specification for the TranslatedText element on the CDISC web site.
The following localized study objects can be imported:
- Forms.
- Sections.
- Items (Question, Text, and Description).
- The decoded value for codelist items.
- Symbols for measurement units.
- Granularity—Granularity is an optional ODM file attribute. If present, it must be set to All or Metadata. If Granularity is set to Metadata, the document cannot contain AdminData , ClinicalData, or ReferenceData sections.
- Naming uniqueness—Oracle Central Designer enforces naming uniqueness with Universal Unique Identifiers (UUIDs). A
UUID is a Global Unique Identifier (GUID) that is created using the Object
Identifier (OID) for a study object. If the OID is not a valid GUID or is
already used by another object, the import process generates a GUID using
Microsoft’s GUID generation algorithm.
For example, during the import, to create a StudyEventOID, Oracle Central Designer:
- Truncates the OID to the maximum allowed length.
- Removes disallowed characters.
In addition, within an ODM import file, ODM allows the reuse of RefNames if the RefName is for a different type of study object. However, Oracle Central Designer requires unique RefNames for all study objects in a study, and for all study objects in an import file. To enforce the uniqueness of RefNames in the import file, Oracle Central Designer adds prefixes to the imported study object RefNames according to the study object type.
If an ODM import file contains study objects with the same RefName, Oracle Central Designer uses the following logic:
- For study objects of the same type, Oracle Central Designer creates a new object with a different ID but the same RefName, and adds a prefix to the RefName.
- For study objects not of the same type, Oracle Central Designer imports the study object and displays a warning that duplicate RefNames exist.
Note:
If you import multiple ODM files, and duplicate RefNames exist between the files, Oracle Central Designer allows you to import the study objects. You must resolve RefName conflicts after import to validate the study.
Oracle Central Designer applies the following prefixes for study objects with duplicate RefNames within an ODM import file.
| CSML object type | Prefix |
|---|---|
| StudyDesign | SD_ |
| StudyEvent | SE_ |
| DataView (from the FormDef definition in the ODM import file) | DF_ |
| DataView (from the ItemGroupDef definition in the ODM import file) | DI_ |
| IntegerVariable, FloatVariable, DateTimeVariable, or TextVariable | VR_ |
| CodeList | CL_ |
| CodeListItem | CI_ |
Parent topic: Import and export