BIG Health Enterprise Service Portfolio
NCI ClinicalTrials
ReportingProgram
ca-AERS
PSC C3PR C3D
caBIG® Clinical Trials Suite
caGrid
RRegistration
AeAdverse
Event
PtProtocol
caTissue caEHR
“BU
SIN
ES
S”
“CO
RE
”
PLTFirebird
“CA
PA
BIL
ITY
”
SSpecimen
ScScheduling
TxTranslation
AuAudit
RaReferral andAuthorization
HxHx and Physical
VaValidation
EvEnterpriseVocabulary
OOrganization
PPerson
AAgent
DDisease
CCorrelation
PaProtocol
Abstraction
DnDischarge
Note
CqClinical
Research Qry
TpTreatment
Plan
DsDecisionSupport
IImage
LLab
RxPrescription
“Inf
ra /
UT
ILIT
Y”
CmContract
Management
MpMaster
Problem List
AyAllergy
SdSDTM
EEligibility
KmKnowledge
Management
CrCredentialing
OcStudy
Outcomes
QrData
Query
IdId
Management
TrTrust
Management
AaAuthorization Authentication
PyPolicy
OoOrders
Observations
Enterprise Service Portfolio Explanation
• The table has 6 layers
1. User applications
2. The Grid as the glue and preferred deployment environment
3. Layers of Services 1. Business Services – Services focused on states of business processes and transactions
that blend well with human processes
2. Capability Services – Services focused on coherent management of key domain structures (for example, Schedules, Specimens, and Images)
3. Core Services – Core Services focus on the management of information structures that are central to BIG Health
4. Utility / Infrastructure Services – Represent reusable pieces of functionality that leverage healthcare IT practices for dealing with rich semantics and interoperability in the clinical and research areas (for example, Enterprise Vocabulary Services, Security Services, and Knowledge Management)
Enterprise Service PortfolioExplanation (cont’d)• The scope of this portfolio is BIG Health, of which NCI is a
“customer” as well as a “contributor”• Business, Capability, and Core Services are more central to clinical
research activities on the left, clinical practice on the right• Utility / Infrastructure Services are applicable across the board• Outlines …
• Solid outlines indicate services that are in production in some way.• Dashed lines indicate services that require specification.• Dashed red lines indicate services that are currently being specified
under a project within CBIIT.• Colored boxes indicate families of services (from an architectural
perspective, not a business perspective)• Service Titles may encompass more than one aspect of a given topic
• For example, Specimen Management deals both with tracking specimen in transit as well as freezer-level management
Enterprise Service PortfolioKey Architectural Patterns
IImage
LLab
RxPharmacy
• Images, Labs, and Pharmacy all exhibit common patterns of Orders and Observations
OOrganization
PPerson
AAgent
DDisease
CCorrelation
PaProtocol
Abstraction
• These core information structures are handled as semantic entities, and relationships between them conform to HL7 RIM semantics via the Correlation Service
IdId
Management
TrTrust
Management
AaAuthorization Authentication
PyPolicy
• These Infrastructure and Utility Services are part of an extensible security Infrastructure. These pieces use other services to implement security (for example, the Correlation Service)
QrData
Query
• The Query, Locate, and Retrieve pattern is a parameterized service pattern for exposing data consistently. Silver Compatible Data Services are one type of Qr object.
Enterprise Service PortfolioComposing Services
• Composing Services• Promotes reuse and
agility• Offers flexible
deployment options• Federates and
Centralizes as needed
• Tracking• Management• Reporting
• CBM
• Tracking• Management• Reporting
• CBM
SMS will provide the core specification for
specimen management from both the
clinical and research perspectives
regardless of the nature of specimen
transactions that occur or the type of
specimens involved in the transaction.
OOrganization
DDisease
CCorrelation
PaProtocol
Abstraction
•Subject Management
•Subject Management
•Specimen Collection Protocol
•Specimen Collection Protocol
Enterprise Service PortfolioDetails on Business Services (“more” trial-based)
“BU
SIN
ES
S”
• Evaluate Subject • Evaluate Subject
Eligibility provides the capabilities
associated with establishing eligibility for a
patient to receive a procedure or set of
procedures based on financial or individual
permission
• Evaluate Patient• Evaluate for Inclusion•
• Evaluate Patient• Evaluate for Inclusion•
Clinical Research Query is based on HL7’s
Clinical Research Functional Query
specification, It provides an interface to an
algorithm to run rules based on clinical
research inclusion and exclusion criiteria
• Query• Query
Study Outcomes establishes a set of
reporting patterns for collecting data and
validating it in order to report on a particular
study’s outcomes.
• Register • Query•
• Register • Query•
Provides a cohesive capability for
managing information associated with a
Protocol and the processes around it
•
•
The Adverse Event service manages,
queries, reports adverse events and the
workflows around them
• Register for Jurisdiction• Register for Jurisdiction
The Registration Service provides a
means to establish a subject on a trial
Enterprise Service PortfolioDetails on Business Services (“more” clinical)
“BU
SIN
ES
S”
• Submit Referral •Query Referral
• Submit Referral •Query Referral
Referral and Authorization provides an
integration point for cross-organization
healthcare teams to coordinate workflow
around patient care
•Submit Order•Submit Observation•Query
•Submit Order•Submit Observation•Query
provides a set of caOrders and
Observations pabilities that .focus on the
submission of orders and the return of their
expected results.
• Query• Query
Provides access to a patient’s History and
Physical document
• Query• Query
Provides access to a patient’s Discharge Notes for a given encounter
Enterprise Service PortfolioDetails on Capability Services
“CA
PA
BIL
ITY
”
• Tracking• Management• Reporting
• CBM
• Tracking• Management• Reporting
• CBM
SMS will provide the core specification for
specimen management from both the
clinical and research perspectives
regardless of the nature of specimen
transactions that occur or the type of
specimens involved in the transaction.
• Management• Query
• Management• Query
Credentialing Management allows the
credentials of a given investigator to be
enumerated and validated by a trusted third
party
• Management• Tracking
• Management• Tracking
TP will provide the core specification for
treatment plan management from both the
clinical and research perspectives
regardless of the nature of the plan itself,
the intersection with other clinical systems,
and so on
• Schedule• Query
• Schedule• Query
The Schedule Service provides the
capabilities associated with scheduling a
particular appointment for a particular
encounter.
• Order Reporting• Manage• Query
• Order Reporting• Manage• Query
Imaging Management Service includes the
ability to order, track, and manage imaging
orders, including intersections with order
reporting
• Order Reporting• Track• Manage• Query
• Order Reporting• Track• Manage• Query
Lab Management Service includes the
ability to order, track, and manage
laboratory orders from a clinical perspective,
including intersections with specimen
management and pathology reporting
• Order Reporting• Track• Manage •Query
• Order Reporting• Track• Manage •Query
Prescription Management Service includes
the ability to order, track, and manage
prescriptions from a clinical perspective
Enterprise Service PortfolioDetails on Core Services
“CO
RE
”
•Query
•Query
SDTM Represents a key data structure that is reused in regulatory reporting..
• Structural Role Management• Functional Role Management• Query
• Structural Role Management• Functional Role Management• Query
Correlation Service establishes a central
service of record for relationships between
core information components (Persons to
Organizations, etc.)
• Management• Query
• Management• Query
Organization Service establishes a central
service of record for the Organization
information type
• Management• Query
• Management• Query
Person Service establishes a central service
of record for the Person Information
.
• Specimen Collection • Study
• Specimen Collection • Study
The Protocol Abstraction Service
establishes a central service of record for
non-annotated, “flat” informatkion about
Protocols and their relation to trials
• Query• Management
• Query• Management
The Disease Service establishes a central
service of record for information about
various diseases found in trials
• Query• Management
• Query• Management
The Agent Service establishes a central
service of record for information about
various agents found in trials
• Management• Query
• Management• Query
Allergy Service establishes a central service
of record for the Allergies tied to patients
• Query • Management
• Query • Management
Master Problem Service establishes a
central service of record for lists of master
problems tied to a patient
Enterprise Service PortfolioDetails on Core Services (using QRL Pattern)
“CO
RE
”
• QBE• Locate• Retrieve
• QBE• Locate• Retrieve
Blah blah
• Retrieve• Locate• QBE
• Retrieve• Locate• QBE
Blah blah
Enterprise Service PortfolioDetails on Utility / Infrastructure Services
“CO
RE
”
• Check for Conformance• Query• Instantiate
• Check for Conformance• Query• Instantiate
Contract Management Service represents a
series of capabilities around the storage,
versioning, and expression of the contract
semantics supporting interoperability
• Management• Evaluate Code• Map Code Systems• Query
• Management• Evaluate Code• Map Code Systems• Query
Enterprise Vocabulary Services support the
management, storage, and mapping of
terminologies and value sets
• Check for Compatibility• Check Conformance
• Check for Compatibility• Check Conformance
The Validation Service verifies structural
and semantic consistency across messages
used in interoperability scenarios
• Translate
• Translate
The Translation Serviice provides a
functional end point to manage and enact
mappings between syntactically disparate
information types
.
• Metadata Management• Model Management• Query
• Metadata Management• Model Management• Query
Knowledge Management Service
represents a series of capabilities around
the storage, versioning, and expression of
the semantics supporting key capabilities
“UT
IL /
IN
FR
A”
Enterprise Service PortfolioDetails on Utility / Infrastructure Services
• Management • Query• Authorize• Authenticate
• Management • Query• Authorize• Authenticate
Authorization and Authentication provides a
means of testing an identity against a set of
credentials and explicit policy within a
deployed architecture
• Query• Management
• Query• Management
Trust Management establishes verifiable
and explicit relationships between
technology endpoints in the deployed
architecture
• Query•Management
• Query•Management
Identity Management deals with identities of
specific entities of interest to the
organization
• Audit• Trace• Query
• Audit• Trace• Query
The Auditing Service provides an interface
that captures auditing information around
the access to sensitive data
• Management • Query• Map Policies
• Management • Query• Map Policies
The Policy Service exposes elaborated,
well-formed policies and rules that manifest
the organization’s permissions, prohibitions,
and obligations
“UT
IL /
IN
FR
A”
•
•
Provides an algorithmically-neutral way to
manage decision support services for
patients
• Register for Jurisdiction• Register for Jurisdiction
The Registration Service provides a
means to establish a subject on a trial
Registration Service
• The Registration Service provides a means to establish a subject on a trial
• Functional Profile(s)
• Register for Jurisdiction
Protocol Service
• Provides a cohesive capability for managing
information associated with a Protocol and the
processes around it
• Functional Profile(s)
• Register – Registers a Protocol for a topic
within a jurisdiction
• Query – Assembles information associated
with particular states in the Protocol Lifecycle• Register • Query•
• Register • Query•
Provides a cohesive capability for
managing information associated with a
Protocol and the processes around it
Study Outcomes Service
• Study Outcomes establishes a set of reporting
patterns for collecting data and validating it in
order to report on a particular study’s outcomes.
• Functional Profile(s)
• Query
• Query• Query
Study Outcomes establishes a set of
reporting patterns for collecting data and
validating it in order to report on a particular
study’s outcomes.
Clinical Research Query Service
• Clinical Research Query is based on HL7’s Clinical
Research Functional Query specification. It provides
an interface to an algorithm to run rules based on
clinical research inclusion and exclusion criteria
• Functional Profile(s)
• Evaluate Patient – Given a set of proteomic and
genetic information, evaluates a patient for
inclusion in a category (for example, a study)
• Evaluate for Inclusion – Given a set of criteria,
evaluates a population for inclusion in a
category
• Evaluate Patient• Evaluate for Inclusion•
• Evaluate Patient• Evaluate for Inclusion•
Clinical Research Query is based on HL7’s
Clinical Research Functional Query
specification, It provides an interface to an
algorithm to run rules based on clinical
research inclusion and exclusion criiteria
Eligibility Service
• Eligibility provides the capabilities associated with
establishing eligibility for a patient to receive a
procedure or set of procedures based on financial
or individual permission
• Functional Profile(s)
• Evaluate Subject
• Evaluate Subject• Evaluate Subject
Eligibility provides the capabilities
associated with establishing eligibility for a
patient to receive a procedure or set of
procedures based on financial or individual
permission
Adverse Event Service
• The Adverse Event service manages, queries,
reports adverse events and the workflows around
them
• Functional Profile(s)
• Query
• Reporting
• Case Management
• AE Management
• Query• Reporting• Case Management• AE Management
• Query• Reporting• Case Management• AE Management
The Adverse Event service manages,
queries, reports adverse events and the
workflows around them
Orders and Observations Service
• Provides a set of Orders and Observations
capabilities that focus on the submission of orders
and the return of their expected results.
• Functional Profile(s)
• Submit Order
• Submit Observation
• Query•Submit Order•Submit Observation•Query
•Submit Order•Submit Observation•Query
provides a set of caOrders and
Observations pabilities that .focus on the
submission of orders and the return of their
expected results.
History and Physical Service
• Provides access to a patient’s History and
Physical document
• Functional Profile(s)
• Query
• Query• Query
Provides access to a patient’s History and
Physical document
Discharge Note Service
• Provides access to a patient’s Discharge Notes for
a given encounter
• Functional Profile(s)
• Query
• Query• Query
Provides access to a patient’s Discharge Notes for a given encounter
Referral and Authorization Service
• Referral and Authorization provides an integration
point for cross-organization healthcare teams to
coordinate workflow around patient care
• Functional Profile(s)
• Submit Referral
• Query Referral
• Submit Referral•Query Referral
• Submit Referral•Query Referral
Referral and Authorization provides an
integration point for cross-organization
healthcare teams to coordinate workflow
around patient care
Specimen Management Service
• SMS will provide the core specification for
specimen management from both the clinical and
research perspectives regardless of the nature of
specimen transactions that occur or the type of
specimens involved in the transaction.
• Functional Profile(s)
• Tracking
• Management
• Reporting
• Common Bio-Repository Model
• Tracking• Management• Reporting
• CBM
• Tracking• Management• Reporting
• CBM
SMS will provide the core specification for
specimen management from both the
clinical and research perspectives
regardless of the nature of specimen
transactions that occur or the type of
specimens involved in the transaction.
Specimen Management Service
• Credentialing Management allows the credentials
of a given investigator to be enumerated and
validated by a trusted third party
• Functional Profile(s)
• Management
• Query
• Management• Query
• Management• Query
Credentialing Management allows the
credentials of a given investigator to be
enumerated and validated by a trusted third
party
Treatment Plan Management Service
• TP will provide the core specification for treatment
plan management from both the clinical and
research perspectives regardless of the nature of
the plan itself, the intersection with other clinical
systems, and so on
• Functional Profile(s)
• Management
• Tracking• Management• Tracking
• Management• Tracking
TP will provide the core specification for
treatment plan management from both the
clinical and research perspectives
regardless of the nature of the plan itself,
the intersection with other clinical systems,
and so on
Schedule Service
• The Schedule Service provides the capabilities
associated with scheduling a particular
appointment for a particular encounter.
• Functional Profile(s)
• Schedule
• Query
• Schedule• Query
• Schedule• Query
The Schedule Service provides the
capabilities associated with scheduling a
particular appointment for a particular
encounter.
Prescription Management Service
• Prescription Management Service includes the
ability to order, track, and manage prescriptions
from a clinical perspective
• Functional Profile(s)
• Order Reporting
• Track
• Manage
• Query• Order Management• Track• Manage • Query
• Order Management• Track• Manage • Query
Drug Management Service includes the
ability to order, track, and manage
prescriptions from a clinical perspective
Lab Management Service
• Lab Management Service includes the ability to
order, track, and manage laboratory orders from a
clinical perspective, including intersections with
specimen management and pathology reporting
• Functional Profile(s)
• Order Reporting
• Track
• Manage
• Query
• Order Reporting• Track• Manage• Query
• Order Reporting• Track• Manage• Query
Lab Management Service includes the
ability to order, track, and manage
laboratory orders from a clinical perspective,
including intersections with specimen
management and pathology reporting
Imaging Management Service
• Imaging Management Service includes the ability
to order, track, and manage imaging orders,
including intersections with order reporting
• Functional Profile(s)
• Order Reporting
• Track
• Manage
• Query• Order Reporting• Manage• Query
• Order Reporting• Manage• Query
Imaging Management Service includes the
ability to order, track, and manage imaging
orders, including intersections with order
reporting
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