BIG Health Enterprise Service Portfolio NCI Clinical Trials Reporting Program ca- AERS PSCC3PRC3D caBIG ® Clinical Trials Suite caGrid R Registration Ae

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


• 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•


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•


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


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

”


• CBM


• CBM







• Management• Query


Credentialing Management allows the

credentials of a given investigator to be

enumerated and validated by a trusted third

party

• Management• Tracking


TP will provide the core specification for

treatment plan management from both the


regardless of the nature of the plan itself,

the intersection with other clinical systems,

and so on

• Schedule• Query


The Schedule Service provides the

capabilities associated with scheduling a

particular appointment for a particular

encounter.

• 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


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.)



Organization Service establishes a central

service of record for the Organization

information type



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


The Disease Service establishes a central

service of record for information about

various diseases found in trials



The Agent Service establishes a central

service of record for information about

various agents found in trials



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



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


• Register – Registers a Protocol for a topic

within a jurisdiction

• Query – Assembles information associated

with particular states in the Protocol Lifecycle• 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.


• 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


• 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



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


• 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


• 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.


• 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


• 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


• 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


• 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



• Tracking

• Management

• Reporting

• Common Bio-Repository Model


• CBM


• CBM







Specimen Management Service

• Credentialing Management allows the credentials

of a given investigator to be enumerated and

validated by a trusted third party


• 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


• Management

• Tracking• Management• Tracking


TP will provide the core specification for

treatment plan management from both the


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.


• 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


• Order Reporting

• Track

• Manage

• Query• Order Management• Track• Manage • Query

• Order Management• Track• Manage • Query

Drug Management Service includes the


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


• Order Reporting

• Track

• Manage

• Query



Lab Management Service includes the


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


• Order Reporting

• Track

• Manage

• Query• Order Reporting• Manage• Query


Imaging Management Service includes the

ability to order, track, and manage imaging

orders, including intersections with order

reporting

Documents

BIG Health Enterprise Service Portfolio NCI Clinical Trials Reporting Program ca- AERS PSCC3PRC3D caBIG ® Clinical Trials Suite caGrid R Registration Ae