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There are two kinds of keys in the ODM: internal and external. Internal keys are used to designate entities within the model, and to allow cross-references between entities within (and between) ODM files. Internal keys are not for human use, and are assumed to be unchanging. Internal keys include subject keys, element OIDs, and repeat keys. To fully identify a clinical data entity, the following internal keys are needed:
form | above plus FormOID and FormRepeatKey |
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A StudyOID uniquely identifies a study. A SubjectKey uniquely identifies a subject within a study. SubjectKeys cannot 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 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 FormRepeatKey.
Each item group in clinical data belongs to a form, and can be identified (within that form) by an ItemGroupOID (which gives its type) and an ItemGroupRepeatKey.
Other items groups are reference data, and can be identified solely by an ItemGroupOID and an ItemGroupRepeatKey.
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