BIG Health Enterprise Service Portfolio NCI Clinical Trials Reporting Program ca- AERS PSCC3PRC3D caBIG ® Clinical Trials Suite caGrid R Registration Ae Adverse Event Pt Protocol caTissuecaEHR “B USINESS ” “ C ORE ” PLTFirebird “C APABILITY ” S Specimen Sc Scheduling Tx Translation Au Audit Ra Referral and Authorization Hx Hx and Physical Va Validation Ev Enterprise Vocabulary O Organization P Person A Agent D Disease C Correlation Pa Protocol Abstraction Dn Discharge Note Cq Clinical Research Qry Tp Treatment Plan Ds Decision Support I Image L Lab Rx Prescription “Infra / U TILITY ” Cm Contract Management Mp Master Problem List Ay Allergy Sd SDTM E Eligibility Km Knowledge Management Cr Credentialing Oc Study Outcomes Qr Data Query Id Management Tr Trust Management Aa Authorization Authentication Py Policy Oo Orders 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 Portfolio Explanation (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 Portfolio Key Architectural Patterns I Image L Lab Rx Pharmacy Images, Labs, and Pharmacy all exhibit common patterns of Orders and Observations O Organization P Person A Agent D Disease C Correlation Pa Protocol Abstraction These core information structures are handled as semantic entities, and relationships between them conform to HL7 RIM semantics via the Correlation Service Id Management Tr Trust Management Aa Authorization Authentication Py Policy 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) Qr Data 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 Portfolio Composing Services Composing Services Promotes reuse and agility Offers flexible deployment options Federates and Centralizes as needed ESST S Specimen Management Service N/D 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. O Organization D Disease C Correlation Pa Protocol Abstraction Subject Management Subject Management Specimen Collection Protocol Specimen Collection Protocol

Enterprise Service Portfolio Details on Business Services (“more” trial-based) “ B USINESS ” CTMS E Eligibility Service N/D 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 CTMS Cq Clinical Research Query N/D Evaluate Patient Evaluate for Inclusion Evaluate Patient Evaluate for Inclusion Clinical Research Query is based on HL7’s Clinical Research Functional Query specification, I t provides an interface to an algorithm to run rules based on clinical research inclusion and exclusion criiteria CTMS Oc Study Outcomes Service N/D 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. CTMS Pt Protocol Service N/D Register Query Register Query Provides a cohesive capability for managing information associated with a Protocol and the processes around it CTMS Ae Adverse Event Service N/D The Adverse Event service manages, queries, reports adverse events and the workflows around them CTMS R Registration Service N/D Register for Jurisdiction The Registration Service provides a means to establish a subject on a trial

Enterprise Service Portfolio Details on Business Services (“more” clinical ) “ B USINESS ” caEHR Ra Referral and Authorization Service N/D 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 ESST Oo Order and Observation Service N/D 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. CTMS Hx History and Physical Service N/D Query Provides access to a patient’s History and Physical document caEHR Dn Discharge Note Service N/D Query Provides access to a patient’s Discharge Notes for a given encounter

Enterprise Service Portfolio Details on Capability Services “C APABILITY ” ESST S Specimen Management Service N/D 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. CTMS Cr Credentialing Management Service N/D Management Query Management Query Credentialing Management allows the credentials of a given investigator to be enumerated and validated by a trusted third party caEHR Tp Treatment Plan Management Service N/D 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 caEHR Sc Schedule Service N/D Schedule Query Schedule Query The Schedule Service provides the capabilities associated with scheduling a particular appointment for a particular encounter. CTMS I Imaging Management Service N/D 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 CTMS L Lab Management Service N/D 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 CTMS Rx Prescription Management Service N/D 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 Portfolio Details on Core Services “ C ORE ” ESST Sd SDTM Service N/D Query Query SDTM Represents a key data structure that is reused in regulatory reporting.. CTMS C Correlation Management Service N/D 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.) caEHR O Organization Service N/D Management Query Management Query Organization Service establishes a central service of record for the Organization information type caEHR P Person Service N/D Management Query Management Query Person Service establishes a central service of record for the Person Information. CTMS Pa Protocol Abstraction Core Service N/D 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 CTMS D Disease Core Service N/D Query Management Query Management The Disease Service establishes a central service of record for information about various diseases found in trials CTMS A Agent Core Service N/D Query Management Query Management The Agent Service establishes a central service of record for information about various agents found in trials CTMS Ay Allergy Core Service N/D Management Query Management Query Allergy Service establishes a central service of record for the Allergies tied to patients CTMS Mp Master Problem Core Service N/D Query Management Query Management Master Problem Service establishes a central service of record for lists of master problems tied to a patient

Enterprise Service Portfolio Details on Core Services (using QRL Pattern) “ C ORE ” CTMS Qe Query By Example Core Service N/D QBE Locate Retrieve QBE Locate Retrieve Blah blah CTMS Qa Array Query Core Service N/D Retrieve Locate QBE Retrieve Locate QBE Blah blah

Enterprise Service Portfolio Details on Utility / Infrastructure Services “ C ORE ” caBIG v2 Cm Contract Management Service N/D 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 caBIG v1 Ev Enterprise Vocabulary Service N/D 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 CTMS Va Validation Service Check for Compatibility Check Conformance Check for Compatibility Check Conformance The Validation Service verifies structural and semantic consistency across messages used in interoperability scenarios CTMS Tx Translation Service N/D Translate Translate The Translation Serviice provides a functional end point to manage and enact mappings between syntactically disparate information types. caBIG v2 Km Knowledge Management Service N/D 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 “ U TIL / I NFRA ”

Enterprise Service Portfolio Details on Utility / Infrastructure Services CTMS Aa Authorization and Authentication Service N/D 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 CTMS Tr Trust Management Service N/D Query Management Query Management Trust Management establishes verifiable and explicit relationships between technology endpoints in the deployed architecture CTMS Id Identity Management Service N/D Query Management Query Management Identity Management deals with identities of specific entities of interest to the organization CTMS Au Auditing Service N/D Audit Trace Query Audit Trace Query The Auditing Service provides an interface that captures auditing information around the access to sensitive data CTMS Py Policy Management Service N/D 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 “ U TIL / I NFRA ” caEHR Ds Decision Support Service N/D Provides an algorithmically-neutral way to manage decision support services for patients

CTMS R Registration Service N/D 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 CTMS Pt Protocol Service N/D 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 CTMS Oc Study Outcomes Service N/D 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 CTMS Cq Clinical Research Query N/D Evaluate Patient Evaluate for Inclusion Evaluate Patient Evaluate for Inclusion Clinical Research Query is based on HL7’s Clinical Research Functional Query specification, I t 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 CTMS E Eligibility Service N/D 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 CTMS Ae Adverse Event Service N/D 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 ESST Oo Order and Observation Service N/D 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 CTMS Hx History and Physical Service N/D 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 caEHR Dn Discharge Note Service N/D 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 caEHR Ra Referral and Authorization Service N/D 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 ESST S Specimen Management Service N/D 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 CTMS Cr Credentialing Management Service N/D 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 caEHR Tp Treatment Plan Management Service N/D 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 caEHR Sc Schedule Service N/D 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 CTMS Rx Prescription Management Service N/D 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 CTMS L Lab Management Service N/D 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 CTMS I Imaging Management Service N/D 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