CDISC ODM defines the
following entities to represent clinical trials (study) data:
describes an individual
study item, such as a single blood pressure reading.
describes a closely
related set of study items that are usually analyzed together.
describes logically
or temporally related information. Forms can contain multiple item
groups.
describes a data collection
event such as a patient visit. A series of forms might be collected
as part of a study event. A study event is associated with a specific
patient in the study.
CDISC ODM defines the
following metadata to describe the types of study events, forms, item
groups, and items that are allowed in the study:
describes a particular
instance of a study event.
describes a particular
instance of a form.
describes a particular
instance of an item.
describes a particular
instance of an item group.
defines a discrete
set of permitted values for an item or a more human-readable description
of an encoded value.
Metadata contains internal
and external attributes that identify the entity for which information
is provided. The internal attributes designate entities within the
model and allow cross-references to be defined between entities, both
within and between CDISC ODM XML documents. Internal attributes include
an object instance identifier (OID), a subject key, and repeat keys.
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An OID uniquely identifies each
entity. For example, a StudyOID is assigned to uniquely identify each
study, a StudyEventOID is assigned to uniquely identify each StudyEventDef
within a study, a FormOID is assigned to uniquely identify each form
used in a StudyEventDef, and so on.
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The subject key identifies a subject
within a study.
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The repeat key identifies an entity
as one of a series. For example, there can be several study events
of a particular type for a particular subject. The repeat key temporarily
relates the distinct study events to each other.
The external attributes
are used by clinical personnel to specify information that is unique
to the entity. These attributes include subject randomization codes,
site codes, and so on. Within CDISC ODM, the attributes are treated
as part of the clinical trials data.
The set of attributes
that are required to reference a single entity is referred to as a
KeySet. For more information about the CDISC ODM KeySet, see
CDISC ODM KeySet Members.