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From the beginning,
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NCI
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CBIIT
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has
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played
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an
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instrumental
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role
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in
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supporting
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the
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clinical
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trial
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process
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within
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NCI,
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with
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other
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agencies
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and
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groups
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in
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NIH
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and
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with
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other
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collaborating
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organizations
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and
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companies.
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A
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significant
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part
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of
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this
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role
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is
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in
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providing
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a
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foundational
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basis
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for
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these
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stakeholders
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to
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leverage
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standard
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terminologies
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and
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metadata,
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and
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a
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standards-based
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framework,
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in
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defining
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semantic
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entities
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related
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to
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clinical
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trials
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such
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as
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forms,
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protocols,
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and
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eligibility
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criteria.
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The
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Semantic
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Infrastructure
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2.0
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will
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expand
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on
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these
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use
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cases,
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in
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order
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to
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both
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facilitate
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data
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collection
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within
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clinical
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trials,
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and
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enable
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the
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information
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collected
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to
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interoperate
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with
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other
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modalities
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in
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caBIG®
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such
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as
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the
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life
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sciences
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domain,
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to
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advance
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knowledge
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in
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disease
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processes
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and
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treatments.
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NCI
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CBIIT
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also
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plays
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a
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leading
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role
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in
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the
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BRIDG
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project,
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which
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will
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form
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a
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significant
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basis
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for
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the
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layered
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approach
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to
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metadata
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and
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terminology
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we
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will
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adopt
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in
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the
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Semantic
...
Infrastructure
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2.0.
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As
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a
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starting
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point,
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requirements
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specific
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to
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the
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clinical
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trials
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domain
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will
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be
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collected
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from
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the
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recent
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Semantic
...
Infrastructure
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Requirements
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Elicitation
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effort,
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from
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the
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NCI
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CBIIT
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in-house
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terminology
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and
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metadata
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curation
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teams,
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and
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from
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related
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projects
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at
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NCI
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CBIIT
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such
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as
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the
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CTRP,
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caBIG®
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Clinical
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Information
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Suite,
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caBIG®
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Clinical
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Trial
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Suite,
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Janus,
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and
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other
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projects.
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Requirements
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are
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also
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being
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collected
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from
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external
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stakeholders
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including
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government
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agencies,
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standard
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development
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organizations
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(SDOs),
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organizations
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and
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companies
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such
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as
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CDISC
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(especially
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the
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SHARE
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project),
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and
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HL7.
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Community
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input
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based
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on
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this
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roadmap
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document,
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and
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the
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forms
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and
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modeling
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workgroup
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in
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the
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Semantic
...
Infrastructure
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2.0
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Inception
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effort,
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will
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form
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another
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significant
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source
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of
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requirements
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from
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the
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clinical
...
trials
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domain.
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