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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.
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Each item belongs to an item group. Beginning with ODM Version 2.0, Item Groups can contain other item groups, Within an ItemGroupData instance, however, there may be only one 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. For clinical data collected in support of submissions to regulatory authorities where CDISC Data Standards are required, the CDISC SDTM and SDTMIG standards 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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