amia now! session one

Standards Influenced Research Information Systems

Interoperability

Session One: Information Modeling

AbdulMalik Shakir, Information Management StrategistCity of Hope, Duarte, CA

Standards Influenced Research Information Systems Interoperability Slied: 2 of 29

About Me

Abdul-Malik Shakir

• Information Management Strategist with City of Hope• Principal Consultant with Shakir Consulting• HL7 Member since 1991

– Co-Chair of the HL7 Education Workgroup– Member of the HL7:

• Architectural Review Board• Public Health and Emergency Response Workgroup• Regulated Clinical Research Information Management Workgroup• Modeling and Methodology Workgroup

• Member of the BRIDG Board of Directors since January 2010• Modeling Facilitator for CTR&R, SAP, STDM, and caEHR

May 2010


Research Informatics Systems Engineering

Research Informatics Systems Engineering

Systems Analysis and

Quality Assurance

Solutions Architecture and

Standards

Database Administration and

Inter-system Interface

Solutions Engineering and

Support

Research Informatics Cores

· Biomedical Research Informatics

· Translational Research Informatics

· Clinical Research Informatics

Research Admin/Operations

· Clinical Research Information Mgt

· Clinical Trial Operations

· Cancer Registry

External Research Entities

City of Hope Research

Community

External Research

Community

· National Comprehensive Cancer Network

· National Center for Research Resources

· American Society of Clinical Oncology

Information Technology

Services

Standards Development Organizations

May 2010


Session Overview• Domain Analysis Modeling

– The Value of Modeling– What is a Domain Analysis Model (DAM)– What is the Unified Modeling Language (UML)– Biomedical Research Integrated Domain Group (BRIDG – Domain Analysis Model)

• HL7 Clinical Trail Registration & Results DAM– Requirements Gathering– BRIDG DAM Mapping– BRIDG Subset Definition

• COH Semantic Interoperability Infrastructure– Metadata Services– Terminology Services– Ontology Services– Rule Services

May 2010


Domain Analysis Modeling

TEST RESULTAmountAmount Unit CodeCodeDateDescriptionDescription Code

PARTY

LOCATIONAddressIdentification NumberNameSetting CodeType Code

SPECIMENCollection DateDescriptionIdentification NumberNameSource CodeType Code

HEALTH RELATED ACTIVITYBegin Date TimeDisposition Date TimeDisposition DescriptionEnd DateIdentification NumberNotification IndicatorPriority CodeSource Type Code

Type Code

HEALTH STATUS INQUIRYAmountAmount Unit CodeBegin DateDescriptionDescription CodeDurationDuration Unit CodeEnd DateLive Births NumberManufacturer Lot NumberManufacturer NameReason TextResult DateResult TextStatus CodeStatus DateTravel Country NameType Code

DIAGNOSISClassification Scheme Code

Disease CodeDiagnosis CodeDiagnosis DateSource CodeSource Text

PUBLIC HEALTH NOTIFICATIONBegin DateEnd DateIdentification NumberReason Code

INTERVENTIONAmountAmount NumberAmount Unit CodeDescriptionDurationDuration Unit CodeEnrollment CodeEnrollment Type CodeManufacturer Lot NumberManufacturer NameNameRoute CodeStatus CodeStatus Date

REFERRALReferral Basis CodeReferral Type NameReferral Acceptance Code

BILLING ACCOUNT

PARTY TO PARTY ASSOCIATIONBegin DateCodeEnd Date

CASE DEFINITIONBegin DateCategory Code

DescriptionEnd DateName

PARTY CONDITIONBegin DateDescriptionEnd DateNameName Status TextStatus Date

PARTY NOTIFICATIONBegin DateEnd DateNotification Receiver Identification NumberNotification Sender Identification Number

PARTY ACTIVITY ROLEBegin DateEnd DateRole Code

DISEASE CAUSING AGENTAgent Type Code

Agent Name

PARTY CASE ROLEBegin DateEnd DateRole Code

PARTY CASE DEFINITION ROLEBegin DateEnd DateRole Code

PARTY LOCATION ROLEBegin DateEnd DateRole CodeStatus CodeStatus Date

TEST

DISEASE ASSOCIATIONDisease CodeDisease Imported CodeEtiologic Status CodeEtiologic Status DateExposure Begin DateExposure End DateInfection (or Illness) Type Code(s)

SPECIMEN LOCATIONBegin DateEnd Date

PERSON NAMEDegree NameFirst NameLast NameMiddle NamePrefix NameSuffix NameType Code

PATIENT COVERAGEProvider Code

VEHICLEDescriptionName(Implication) Status CodeStatus DateType Code

CASEBegin DateConfirmation Method Code

CountCount Type CodeDetection Method CodeEnd DateIdentification NumberTransmission Mode CodeStatus CodeStatus Date

ADDRESSBegin DateCity NameCountry NameCounty NameEnd DatePostal CodeStatus DateState CodeStreet Address Text

Type Code

TELEPHONETelephone Type Code

Area CodeNumber

CODECodeDescriptionCoding System Name

ORGANIZATIONAlias NameNameType Code

EntityNameType

INDIVIDUAL

PERSONBirth DateDeath DateEthnicity CodeRace CodeSex CodeSoundex TextOccupation Name

NON PERSON LIVING ORGANISMGenus NameSpecies Name

INFORMAL ORGANIZATION Formal OrganizationIndustry Code

PARTY IDENTIFICATION NUMBERIdentification NumberIssuing Authority NameIssue Begin DateIssue End DateType Code

TEST REFERENCE TABLEMethod CodeName

Samples Required NumberSamples Required Unit Code

Type Code

PARTY SPECIMEN ROLEBegin DateEnd DateRole Code

PARTY VEHICLE ROLEBegin DateEnd DateRole Code

OUTBREAK STATISTICAmountCategory CodeType Code

VEHICLE CONDITIONDescriptionDescription Status CodeStatus Date

OutbreakBegin DateEnd DateExtent CodePeak Date

May 2010


Why Model

• To aid in understanding relevant functions and information needs of a particular domain

• To communicate the modeler’s understanding of the domain and allow that understanding to be assessed by others

• To aid in reconciling multiple perspectives of a domain by combining varying perspectives into a single specification

• To document a solution design (existing or planned) so that the design may be evaluated

May 2010


Revealing assumptions is an essential component of effective communication.Data models are an effective means of documenting our assumptions

about a domain

Yes, I doplay

football.

Do youplay

football?

Reveal Assumptions

May 2010


Modeling provides a language that allows us to unambiguously express our understanding and assumptions about the actions and information of

interest in a particular domain

Reduce AmbiguityA

C

B

0..*

0..*

0..* 1

May 2010


Sharing models provides an opportunity to identify and reconcile conflicts in our understanding

and to validate our assumptions.

Reconcile ConflictsA

C

B

0..*

0..*

0..* 1 X

C

B

0..*

0..*

0..* 1

May 2010


Sharing models also provides an opportunity to identify gaps in our understanding.

No one of individual has the complete view of domain of interest.

Expand UnderstandingA

C

B

0..*

0..*

0..* 1

D

A B0..* 0..*

0..*

1

May 2010


Consolidate Ideas

Model I Model II Model III

B

X F

E

C A D

G

1

0..*

0..* 1 0..* 1

0..* 0..1 0..*1

A

C

B

0..*

0..*

0..* 1 X

C

B

0..*

0..*

0..* 1

D

A B0..* 0..*

0..*

1

May 2010


Value of Modeling

• Reveal Assumptions

• Reduce Ambiguity

• Reconcile Conflicts

• Expand Understanding

• Consolidate Ideas

May 2010

Standards Influenced Research Information Systems Interoperability

What is a Domain Analysis Model

• A Domain Analysis Model (DAM) is a conceptual model used to depict the behavioral and static semantics of a domain of interest.

• A DAM provides an opportunity for subject matter experts (SMEs) within a particular domain to integrate and harmonize their perspectives regarding the use cases, activities, and information needs of their shared domain.

• A DAM is particularly useful when used in a domain with broad interests and a diverse population of SMEs.

13May 2010


Domain Analysis Model Use

• A domain analysis model is used as reference material in development of information system interoperability specifications as well as design specifications of information system components

• The DAM is a requirement specification and is the primary artifact from which information system design specifications are derived.

• The preferred language for expression of a domain analysis model is UML.

14May 2010


Unified Modeling Language (UML)

• UML is a standardized general-purpose modeling language in the field of software engineering.

• UML is not a development method; however, it was designed to be compatible with the leading object-oriented software development methods.

• UML includes a set of graphical notation techniques to create visual models of software-intensive systems.

15May 2010


UML Diagram TypesDiagram Description Classification

Activity Diagram Depicts high-level business processes, including data flow, or to model the logic of complex logic within a system.

Behavior

Class Diagram Shows a collection of static model elements such as classes and types, their contents, and their relationships.

Structure

Communication Diagram Shows instances of classes, their interrelationships, and the message flow between them. Communication diagrams typically focus on the structural organization of objects that send and receive messages.

Interaction

Component Diagram Depicts the components that compose an application, system, or enterprise. The components, their interrelationships, interactions, and their public interfaces are depicted.

Structure

Composite Structure Diagram Depicts the internal structure of a classifier (such as a class, component, or use case), including the interaction points of the classifier to other parts of the system.

Structure

Deployment Diagram Shows the execution architecture of systems. This includes nodes, either hardware or software execution environments, as well as the middleware connecting them.

Structure

Interaction Overview Diagram A variant of an activity diagram which overviews the control flow within a system or business process. Each node/activity within the diagram can represent another interaction diagram.

Interaction

Object Diagram Depicts objects and their relationships at a point in time, typically a special case of either a class diagram or a communication diagram.

Structure

Package Diagram Shows how model elements are organized into packages as well as the dependencies between packages.

Structure

Sequence Diagram Models the sequential logic, in effect the time ordering of messages between classifiers. Interaction

State Machine Diagram Describes the states an object or interaction may be in, as well as the transitions between states.

Behavior

Timing Diagram Depicts the change in state or condition of a classifier instance or role over time. Typically used to show the change in state of an object over time in response to external events.

Interaction

Use Case Diagram Shows use cases, actors, and their interrelationships. Behavior

May 2010


Domain Analysis Model Diagrams

17

UC0001 Clinical Trial Registration

UC0002 Clinical Trial Registration Solicited

Update

UC0003 Clinical Trial Registration Unsolicited

Update

UC0004 Clinical Trial Registration Status

Request

UC0006 Secondary Clinical Trial Registration

UC0005 Collaborativ e Clinical Trial Registration

UA0004 Additional Registration Authority

UA0006 Delegated Organization

UA0001 Sponsoring Organization

UA0002 Registration Authority

UA0005 Public Trial Registry

Name:Package:Version:Author:

Use CasesUse Cases1.0AbdulMalik Shakir

UA0001 Sponsoring Organization

UA0002 Registration Authority

UA0005 Public Trial Registry

UA0003 Initial Registration Authority

UA0004 Additional Registration Authority

UA0006 Delegated Organization


Use Case ActorsUse Case Actors1.0AShakir

Clinical Trial Registration Activ ities

+ A01: Send completed clinical trial registration information

+ A02: Receive clinical trial registration information

+ A04: Assign a registry identifier to the clinical trial

+ A05: Send clinical trial registration acceptance notice

+ A08: Send clinical trial registration rejection notice

+ A09: Receive clinical trial registration rejection notice

+ A10: Send clincal trial registration rejection notice acknowledgement

+ A03: Review clinical trail registration information

+ A06: Receive clinical trial registration acceptance notice

+ A07: Send clinical trial registration acceptance notice aknowledgement

(from Use Cases)

UC0001 Clinical Trial Registration

Sponsoring Organization:UA0001 Sponsoring Organization Registration Authority (RA):UA0002 Registration Authority

A06: Receiv e clinical trialregistration acceptance

notice

A07: Send clinical trialregistration acceptance notice

aknowledgement

A03: Rev iew clinical trailregistration information

«message»MT140001 Clinical Trial Registration Information

«message»MT140002 Clinical Trial

Registration Rejection Notice

«message»MT140003 Rejection Notice

Acknowledgement


Registration Acceptance Notice


Registration Acceptance Notice Acknowledgement

A01: Send completedclinical trial registration

information

A02: Receiv e clinical trialregistration information

A04: Assign a registryidentifier to the clinical trial

A05: Send clinical trialregistration acceptance

notice

A08: Send clinical trialregistration rejection

notice

A09: Receiv e clinical trialregistration rejection notice

A10: Send clincal trialregistration rejection

notice acknowledgement

«flow»

[Rejected]

[Accepted]

«flow»

«flow»

«flow»

«flow»

«flow»

«flow»

«flow»

Clinical Trial Registion Interactions

+ Registration Authority

+ Sponsoring Organization



+ A02: Receive clinical trial registration information

+ A04: Assign a registry identifier to the clinical trial

+ A05: Send clinical trial registration acceptance notice

+ A08: Send clinical trial registration rejection notice

+ A09: Receive clinical trial registration rejection notice

+ A10: Send clincal trial registration rejection notice acknowledgement


+ A06: Receive clinical trial registration acceptance notice

+ A07: Send clinical trial registration acceptance notice aknowledgement

(from CTRR DAM Activity Specifications)

«trace»

Sponsoring Organization:UA0001 Sponsoring

Organization

Registration Authority:UA0002 Registration

Authority

MT140001 Clinical Trial Registration Information

«message»

MT140002 Clinical Trial Registration Rejection Notice

«message»

MT140003 Rejection Notice Acknowledgement

«message»

MT140004 Clinical Trial Registration Acceptance Notice

«message»

MT140005 Acceptance Notice Acknowledgement

«message»


Clinical Trial Registion InteractionsClinical Trial Registion Interactions1.0ashakir

Documents

+ Document

+ DocumentIdentifier

+ RegulatoryApplication

+ StudyProtocolDocument

+ Submission

+ SubmissionUnit

Activ ities

+ Activity

+ Performer

+ Defined Activity

+ Performed Activity

+ Planned Activity

Materials

+ BiologicSpecimen

+ Material

+ Product

Organizations

+ Organization

+ OversightAuthority

+ OversightCommittee

+ Registry

+ RegulatoryAuthority

+ ResourceProvider

+ StudySite

Persons

+ BiologicEntity

+ HealthcareProvider

+ Person

+ StudyContact

+ StudyInvestigator

+ StudySiteContact

+ StudySiteInvestigator

Studies

+ ExpandedAccessStudy

+ InterventionalStudy

+ ObservationalStudy

+ Study

+ StudyAgent

+ StudyLegalSponsor

+ StudyObjective

+ StudyOutcomeMeasure

+ StudyOverallStatus

+ StudyRecruitmentStatus

+ StudyReference


CTRR DAM Class PackagesCTRR DAM Classes1.0AShakir

Study{root}

- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

ExpandedAccessStudy{leaf}

::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Interv entionalStudy{leaf}

- acceptsHealthyVolunteersIndicator: BL- al locationCode: CD- blindedRoleCode: SET<CD>- blindingSchemaCode: CD- controlConcurrencyTypeCode: CD- controlTypeCode: CD- interventionDescription: ST::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Observ ationalStudy{leaf}

- timePerspectiveCode: CD- samplingMethodCode: CD::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Activity

Planned Activity::PlannedActivity

StudyAgent

- functionCode: CD

PerformedActivity

Performed Activ ity::PerformedProcedure{leaf}

Material

Materials::Product{leaf}

StudyLegalSponsor

Organizations::Organization

Persons::HealthcareProv ider

StudyObjectiv e

- description: ST- primaryIndicator: BL

StudyOutcomeMeasure

- name: ST- primaryIndicator: BL- timeFrameText: ST- typeCode: SET<CD>

StudyOv erallStatus

- anticipatedIndicator: BL- statusCode: CD- statusDate: TS.DATETIME- studyStoppedReasonCode: CD

StudyRecruitmentStatus

- statusCode: CD

StudyReference

- citationDescription: ST- publicationIdentifier: II- publicationName: ST- universalResourceLocator: URL

0..*

describes

{is describedby}

1

1..*

describes

{is describedby}

1

0..*

uses

{is usedduring}

0..*

0..1

is a function performed by {functions as}

0..1

1..*

refersto{is referenced by} 0..*

1..*

measures

{is measured by} 1..*

0..*

is responsiblefor{is the responsibil i ty of}1

0..*

is a function performed by{functions as}

0..1

0..*

is evaluated by

{is evaluating} 1

1..*

is an aim of {aims to achieve}

1

0..*

is a function performed by {functions as}

1


StudyStudies1.0AShakir

Planned Activity::Arm{root}

- description: ST- name: ST- typeCode: CD

Documents::Document{root}

- keywordText: SET<ST>- officialTitle: ST

Documents::DocumentIdentifier

- identifier: II- typeCode: CD

Studies::ExpandedAccessStudy{leaf}

::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Persons::HealthcareProvider

Studies::InterventionalStudy{leaf}

- acceptsHealthyVolunteersIndicator: BL- allocationCode: CD- blindedRoleCode: SET<CD>- blindingSchemaCode: CD- controlConcurrencyTypeCode: CD- controlTypeCode: CD- interventionDescription: ST::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Studies::ObservationalStudy{leaf}

- timePerspectiveCode: CD- samplingMethodCode: CD::Study- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Organizations::Organization

- name: SET<ON>- typeCode: CD

Organizations::OversightCommittee{leaf}

- typeCode: CD

Performed Activity::PerformedAdministrativeActivity{leaf}

::Activity- identifier: II- statusCode: CD

Performed Activity::PerformedProcedure{leaf}


Persons::Person{leaf}

- name: PN- telecomAddress: BAG<TEL>

Organizations::Registry

- acronym: ST- name: ST

Documents::RegulatoryApplication

- identifier: II- typeCode: CD

Organizations::RegulatoryAuthority{leaf}

- jurisdictionCode: CD

Organizations::ResourceProvider{root}

Planned Activity::ScheduledActivity{leaf}


Studies::StudyAgent

- functionCode: CD

Persons::StudyContact{root}

- roleCode: CD

Persons::StudyInvestigator{leaf}

::StudyContact- roleCode: CD

Studies::StudyLegalSponsor

Studies::StudyObjective

- description: ST- primaryIndicator: BL

Studies::StudyOutcomeMeasure

- name: ST- primaryIndicator: BL- timeFrameText: ST- typeCode: SET<CD>

Studies::StudyOverallStatus

- anticipatedIndicator: BL- statusCode: CD- statusDate: TS.DATETIME- studyStoppedReasonCode: CD

Documents::StudyProtocolDocument

{leaf}

- publicDescription: ST- publicTitle: ST

Studies::StudyRecruitmentStatus

- statusCode: CD

Organizations::StudySite

- accrualStatusCode: CD- targetAccrualNumber: INT

Persons::StudySiteInvestigator{leaf}

::StudySiteContact- postalAddress: AD

Organizations::OversightAuthority

{root}

Planned Activity::PlannedActivity

Documents::Submission

Documents::SubmissionUnit

Persons::BiologicEntity{root}

Performed Activity::PerformedActivity{leaf}


Activities::Activity{root}

- identifier: II- statusCode: CD

Studies::Study{root}

- acronym: ST- designConfigurationCode: CD- diseaseCode: SET<CD>- participatingCountryCode: SET<CD>- phaseCode: CD- plannedStudySubjectExperience: ST- populationDescription: ST- primaryPurposeCode: CD- purposeStatement: ST- studySchematic: ED- targetAccrualNumberRange: URG<INT>

Persons::StudySiteContact{root}

- postalAddress: AD

Studies::StudyReference

- citationDescription: ST- publicationIdentifier: II- publicationName: ST- universalResourceLocator: URL

Planned Activity::PlannedContingentOnRelationship

- evaluableExpression: ED

Defined Activity::DefinedActivity{leaf}

- nameCode: CD::Activity- identifier: II- statusCode: CD

Defined Activity::DefinedSubstanceAdministration{leaf}

- doseRegimen: ST- routeOfAdministrationCode: CD::DefinedActivity- nameCode: CD::Activity- identifier: II- statusCode: CD

Defined Activity::DefinedProcedure{leaf}

::DefinedActivity- nameCode: CD::Activity- identifier: II- statusCode: CD

Materials::Product{leaf}

- nameCode: CD::Material- name: SET<TN>

Activities::Performer

Performed Activity::PerformedStudyAdministrativeActivity

{leaf}


Materials::Material{root}

- name: SET<TN>

Materials::BiologicSpecimen{leaf}

::Material- name: SET<TN>

0..*

is evaluatedby

1

0..*

is a functionperformed by

0..1

0..*

isresponsiblefor

1

0..*

is theexecutionof

1

0..1


1

0..1

is outcome of

«ADDED»{assigns}

0..1

0..*

oversees

0..*

0..* isperformedat

0..1

0..*

handlescommunicationsfor

1

0..*

executes

1

0..*

is afunctionperformedby

0..1

1..*

measures

1..*

0..*

includes

1..*

0..*

instantiates

0..1

0..*

isissuedby

0..1

0..*

identifies

1

1..*isgroupedby

1

1..*is anaimof

1

0..*isgroupedinto

0..1

0..*

is a function performed by

1

0..*

occurs inthecontext of

0..1

0..*

has as subject

{is the subject for}1

1..*

refersto

0..*

0..1is afunctionperformedby

0..1 0..1


0..1

0..*

instantiates

0..1

0..*

instantiates

1

1..*

handlescommunicationsfor

1

0..*

describes

1

0..*

isdefinedby

0..1

0..*

performs

1..*

1..*

describes

1

1..*

occursin

1..*

0..*


0..1

0..*


0..1

0..1


0..1

0..*

is afunctionperformedby

1

0..*

iscontingentupon

0..1

0..*

is aconditionfor

1

0..* is managed by

1

0..*

is adivisionof

1

0..*

uses

0..*

0..*


0..1

0..*

is issued by

0..1


CTRR DAM ClassesCTRR DAM Classes1.0AbdulMalik Shakir

«message»MT140005 Clinical Trial Registration

Acceptance Notice Acknow ledgement


Acceptance Notice


Information


Rejection Notice

«message»MT140003 Rejection Notice

Acknow ledgement


Clinical Trial Registration ObjectsClinical Trial Registration Objects1.0AbdulMalik Shakir

Clinical Trial Registration Objects

+ MT140001 Clinical Trial Registration Information

+ MT140002 Clinical Trial Registration Rejection Notice

+ MT140003 Rejection Notice Acknowledgement

+ MT140004 Clinical Trial Registration Acceptance Notice

+ MT140005 Clinical Trial Registration Acceptance Notice Acknowledgement



+ A02: Receive cl inical trial registration information

+ A04: Assign a registry identifier to the cl inical trial

+ A05: Send cl inical trial registration acceptance notice

+ A08: Send cl inical trial registration rejection notice

+ A09: Receive cl inical trial registration rejection notice

+ A10: Send cl incal trial registration rejection notice acknowledgement


+ A06: Receive cl inical trial registration acceptance notice

+ A07: Send cl inical trial registration acceptance notice aknowledgement

(from CTRR DAM Activity Specifications)

CTRR DAM Classes

+ Documents

+ Activities

+ Materials

+ Organizations

+ Persons

+ Studies

(from CTRR DAM Information Requirements Specification)

Clinical Trial Registion Interactions

+ Registration Authority

+ Sponsoring Organization

(from CTRR DAM Interaction Specifications)

«trace»

«trace»


CTRR DAM ObjectsCTRR DAM Objects1.0AShakir

May 2010


Biomedical Research Integrated Domain Group

18May 2010


From Data Requirements to HL7 Message

CT.GOV Data Requirements

WHO.CTR Data Requirements

EudraCT Data Requirements

CT.GOV BRIDG Mapping

WHO.CTR BRIDG Mapping

EudraCT BRIDG Mapping

text

Biomedical Research Integrated Domain Group (BRIDG) Model

Domain Analysis UML Layer HL7 RMIM Layer

CTRR Domain Analysis Model

CTRR HL7 Message

RMIM

CTRR HL7 Message

HMD

Health Level Seven Reference Information Model

CTRR HL7 Message

Schema

HL7 V3 Core Schema

HL7 V3 Message Wrapper Schema

text

CTRR Ballot Material

May 2010


Requirements Mapping to BRIDG







text


Domain Analysis UML Layer

Data Item Comment Class Attribute Comment1 Accepts on Healthy Volunteers? Indicate if persons who have not had

the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. Select Yes/No.

InterventionalStudy acceptsHealthyVolunteersIndicator

2 Acronym Definition: Acronym or initials used to identify this study, if applicable. Enter only the acronym. If supplied, the acronym is automatically displayed in parentheses following the brief title. Example: Brief Title: Women's Health Initiative Acronym: WHI Displayed on ClinicalTrials.gov as: Women's Health Initiative (WHI)

Study acronym

3 Allocation Participant assignment to intervention group (at least one of the following required: Intervention Model, Masking, Allocation. Allmay be required as part of Study Design under PL 110-85, Section 801)- N/A: single arm study- Randomized Controlled Trial: participants are assigned to intervention groups by chance- Nonrandomized Trial: participants are expressly assigned to intervention groups through a nonrandom method, such as physician choice

InterventionalStudy allocationCode

4 Arm Description (note: above data element definition incorrect?) (aka Group/cohort Description)

Brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.

Arm description

5 Arm Label (aka Group/Cohort Label) The short name used to identify the arm.Examples:- Metformin- Lifestyle counseling- Sugar pill

Arm name

6 Arm Type Select one- Experimental- Active Comparator- Placebo Comparator- Sham Comparator- No intervention- Other

Arm typeCode

CT.GOV Data RequirementID BRIDG Model Element

May 2010


BRIDG Subset to CTRR DAM




text


Domain Analysis UML Layer


Person{leaf}

+ deathIndicator: BL+ educationLevelCode: CD+ ethnicGroupCode: DSET<CD>+ initials: ST+ maritalStatusCode: CD+ occupationDateRange: IVL<TS.DATE>+ primaryOccupationCode: CD+ raceCode: DSET<CD>::BiologicEntity+ actualIndicator: BL+ administrativeGenderCode: CD+ birthCountryCode: CD+ birthOrder: INT+ birthDate: TS.DATETIME+ deathDate: TS.DATETIME

«CTRR»+ name: PN+ postalAddress: AD+ telecomAddress: BAG<TEL>

Materials::BiologicEntity{root}

Activ ities::Performer{root}

HealthcareProv ider

+ identifier: II+ certificateLicenseText: ST+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>Organizations::OrganizationalContact

ResearchStaff

+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>

Documents::RegulatoryApplicationSponsor

Study::StudyInv estigator

{leaf}

Organizations::StudySiteContact{root}

Study::StudyColleague{root}

Resources::ResourceProv ider{root}

0..*


0..10..*


0..1

0..1


0..*

0..*


0..1

0..*


1

0..*


0..1

0..1


0..1

0..*


0..1

0..*


1


PersonsPersons1.0AbdulMalik Shakir

May 2010


CTRR DAM to CTRR HL7 Message RMIM




CTRR HL7 Message

RMIMTargetedAccrual

classCode*: <= SPLYmoodCode*: <= INTcode: CD CWE [0..1] < ActCode ("Accural")quantity: INT [0..1] (Study.targetAccuralNumberRange; StudySite.targetAccuralNumber)

0..* targetedAccrual

typeCode*: <= COMPcomponent

0..* researchSubject

typeCode*: <= PRDproduct

0..1 subjectEnrolledSubjectKind

ResearchSubject

classCode*: <= RESBJ

EnrolledSubjectKind

classCode*: <= ENTdeterminerCode*: <= QUANTIFIED_KINDquantity: PQ [0..1] (StudySite.targetAccuralNumber)desc: ST [0..1] (Study.populationDescription)

0..1 locationCountry

SubjectLocation

0..* asSubjectLocation classCode*: <= LOCE

Country

classCode*: <= COUNTRYdeterminerCode*: <= INSTANCEcode: CD CWE [0..1] < EntityCode (Study.participatingCountryCode)

InformIntent

classCode*: <= INFRMmoodCode*: <= INTtext: ST [0..1]

0..* researchSubject

typeCode*: <= SBJsubject

0..* informIntent typeCode*: <= SUBJsubjectOf1

PlannedContingentOnRelationship

classCode*: <= OBSmoodCode*: <= EVN.CRTvalue: EXPR<BL> [0..1] (PlannedContingentOnRelationship.evaluableExpression)

0..* plannedContingentOnRelationship

typeCode*: <= PRCNprecondition

May 2010


CTRR HL7 Message RMIM to HMD


HL7 RMIM Layer

CTRR HL7 Message

RMIM

CTRR HL7 Message

HMD


May 2010


CTRR HL7 MESSAGE HMD TO CTRR.XSD

CTRR HL7 Message

HMD


CTRR HL7 Message

Schema

HL7 V3 Core Schema


text

May 2010


From Requirements to HL7 Message







text




CTRR HL7 Message

RMIM

CTRR HL7 Message

HMD


CTRR HL7 Message

Schema

HL7 V3 Core Schema


text

CTRR Ballot Material

May 2010


Domain Analysis Model

DAM

Domain Conceptual Model

DCM

HL7 Reference Information Model

RIM

Enterprise Reference Model

ERM

Enterprise Conceptual Model

ECMBiomedical

Research Integrated Domain Group

BRIDG

Domain Logical Model

DLM

Enterprise Logical Model

ELM

Domain Physical Model

DPM

Enterprise Physical Model

EPM

Reverse Engineered Model

REM

Transformation

Harmonization

Domain

Enterprise

External Reference

City of Hope Research Informatics Enterprise Architecture Framework

Family of Models

03/16/2010

LLogical

CConceptual

PPhysical

May 2010


Semantic Interoperability Infrastructure

Metadata Terminology Ontology

Metadata Services

Terminology Services

Ontology Services

Semantics: P11179Structure: SQL

Semantics: CTSStructure: SQL

Semantics: DLStructure: OWL

Information Models

Controlled Terminologies

Bio-Medical Ontologies

Binding

Binding

Rules

Rule Services

Semantics: SVBRStructure: RuleML

BusinessRules

Binding

Semantic Infrastructure

May 2010


Metadata RepositoryTerminology Repository

Ontology Repository

Business Rule Repository

Domain Information

Models

Constrained Information

ModelsHL7 CTS v2 Static Information Model

HL7 Reference Information Model

BRIDG Domain Analysis Model

ISO P11179-3

OWL DL

SVBR

Controlled Clinical

Terminologies

Bio-Medical Ontologies

Semantic Interoperability Infrastructure

May 2010


AbdulMalik ShakirInformation Management Strategist

City of Hope1500 E. Duarte Road

Duarte, CA 91010

Office: (626) 256-4673 x63160 Mobile: (626) 644-4491Email: [email protected]

May 2010

amia now! session one

Documents

information needs

domain analysis model

hl7 education workgroupmember

methodology workgroupmember

modeling facilitator

varying perspectives

multiple perspectives

solution design