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For ODM v2.0, there are 2 forms of the clinical data hierarchy. The full subject data hierarchy (Figure 1) is typical of usage within data collection tools such as EDC systems. The dataset hierarchy (Figure 2) reflects data tabulation formats that are typical of usage for data review and submission. |
The ODM allows for both internal and external keys. Internal keys, known as OIDs,
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are used to designate entities within the model, and to allow cross-references between entities within
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and between
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ODM files.
Internal keys are not optimized for human use
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but are assumed to be unchanging.
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External keys are any keys used by clinical personnel. They are typically represented in ODM metadata by an element Name attribute or a Description child element. They are intended to be useful for data review and interpretation.
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| Kind of Entity | Identifying Keys | Required for Subject data | Required for Dataset data |
| study | StudyOID | X | |
| subject | above plus SubjectKey | X | |
| study event | above plus StudyEventOID and StudyEventRepeatKey | X | |
| item group | above plus ItemGroupOID and ItemGroupRepeatKey | X | X |
| item | above plus ItemOID | X | X |
| annotation | keys for the annotated entity plus SeqNum | X | X |
A StudyOID uniquely identifies a study. A SubjectKey uniquely identifies a subject within a study. SubjectKeys cannot are not intended to be used to identify a subject across studies.
A StudyEventOID uniquely identifies a StudyEventDef within a study. However, there may be several study events of a particular type for a given subject. Thus, to fully identify a particular study event, we need the The StudyOID, the SubjectKey, the StudyEventOID, and a StudyEventRepeatKey .Each form belongs to a study event, and can be identified (within that study event) by a FormOID (which gives its type) and a FormRepeatKeyare all needed to fully identify a particular study event.
Collected data always belongs to an ItemGroup but two forms but either form of the hierarchy maybe may be used within a Clinical Data element.
Each item group in clinical data can be identified (within that form) by an ItemGroupOID ( which gives identifies its type) definition and an ItemGroupRepeatKey which identifies a data collection instance. Other items groups are reference data, and can be identified solely by an ItemGroupOID and an ItemGroupRepeatKey.
Within the ODM ReferenceData element, ItemGroupData does not relate to a study subject.
Each item belongs to an item group. However an item may be referenced only once within an item group. ThusBeginning with ODM v2.0, item groups can contain other item groups, Within an ItemGroupData instance, however, there may be only 1 instance of an ItemOID. That is, only the ItemOID is needed to uniquely identify an item within its item group.
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External keys are any keys used by clinical personnel. These include subject randomization codes, site codes, and so on. In the ODM, external keys are represented as if they were clinical data - i.e. using one of the currently defined ItemData types. Thus external keys can be changed as needed, and are subject to normal auditing processesFor clinical data collected in support of submissions to regulatory authorities where CDISC data standards are required, the CDISC Study Data Tabulation Model (SDTM) and SDTM Implementation Guide detail the requirements for variables used to identify study subjects, study events, and timing and other data elements used in processing the clinical data. |
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