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For ODM Version 2, there are two forms of the clinical data hierarchy. The full hierarchy is typical of usage within data collection tools such as EDC systems. The dataset hierarchy 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, are used to designate entities within the model, and to allow cross-references between entities within and between ODM files. Internal keys are not optimized for human use but are assumed to be unchanging. 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. |
The ODM allows for both internal and external keys. Internal keys, known as OIDs, are used to designate entities within the model, and to allow cross-references between entities within and between ODM files. Internal keys are not optimized for human use but are assumed to be unchanging. External keys are typically represented in ODM metadata by Name attributes or Description child elements. They are intended to be useful for data review and interpretation.
| 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 are not intended to be used to identify a subject across studies.
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