KNOWLEDGE MANAGEMENT SYSTEMS IN CLINICAL TRIALS

David Parrish Director, Biomedical Informatics Immune Tolerance Network

TRANSLATIO

NAL IN

FORM

ATICS AT THE ITN

The ITN: At the crossroads of Clinical and Translational Science

An international research consortium designed to accelerate the clinical development of immune tolerance therapies.

ITN Mission:• To advance the clinical application of immune tolerance by performing high

quality clinical trials of emerging therapeutics integrated with mechanism-based research.

• In particular, we aim to:– establish new tolerance therapeutics– develop a better understanding of the mechanisms of immune function and disease

pathogenesis– identify new biomarkers of tolerance and disease

Each ITN clinical trial incorporates a series of “mechanistic” investigations that complement the clinical study and provide biological insight into disease pathogenesis, immunological effects of therapy, etc.

INFO

RMATIO

NAL M

ANAG

EMEN

T CHALLEN

GES

(just) Two Key Dichotomies

1. Adaptability verses Reusability (standardization) – We encourage and support innovative and diverse design

approaches – While needing shared systems and uniform methods for

managing the implementation of studies and evaluating results

2. Evolving technologies verses Data Longevity (annotation)– We include mechanistic assay technologies that are rapidly

evolving or being developed as the study progress ..or do not yet exist

– While expecting the data to be useful in 5 -10 years

DISCIPLIN

ES OF IN

FORM

ION

MAN

AGEM

ENT

Data Operations vs. Knowledge Management

Clean

Structure

Store

Collect

Dat

a C

lean

ing

Knowledge Representation

Knowledge Acquisition

Knowledge Delivery

Master Data Management

Transactional Systems

Data Annotation

Reporting

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Reference ontology –OWL/ BRIDG

Implementation Model -EF

Local Library

PR

OT

EG

EWe have built the Epoch ontologies using Protégé OWL editor

Ontologies

Epoch

Reference

Protégé Plug-In

ITN KN

OW

LEDG

E MAN

AGEM

ENT SYSTEM

Trial Designer (Trial Wiz)

Act: Activities

Org: Organization

Assay: Assay

Con: Constraint

Mes: Measurement

Lab: labware

CTO: Clinical Trials

Tmp: Temporal

Swrl: Swrl

Epoch– Owl Files Elements and

Relationships Required to Described the Study

Relational Data Store

Trial Designer

Specialized OWL file

Common Data Structure

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Reference Model -BRIDG

Implementation Model -EFM

Static Library A

ctiv

itie

s

Groups Timings

COM

PON

ENTS O

F THE APPLICATIO

N

User interface Components

1

2

3

Specifying Trial Design in the knowledge system – TrialWiz DesignerA U

SER INTERFACE FO

R THE CLIN

ICAL RESEARCH

ER

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Reference Model -BRIDG

Implementation Model -EFM

Static Library A

ctiv

itie

s

Groups Timings

IMM

UN

OTRAK

ImmunoTrak Specimen Tracking

ITN PVT APPLICATIO

N

Patient visits

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Data Representation

Data Value Set Specification

Act

iviti

es

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Data Representation

Data Value Set Specification

Act

iviti

es

Data ElementConcept

Conceptual Domain

Data Element Value Domain

Concepts

Data

0..* 1..1

0..* 1..1

0..

*

1

..1

0..

*

1

..1

More on metadata mgmt

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Data Representation

Data Value Set Specification CaDSR Metadata Repository

Local Metadata Repository

BRIDG

Implementation Model -EF

Local Library

Knowledge Acquisition Data

Concepts Structure

Content

DIA PRESEN

TATION

2009

Knowledge Acquisition

Expert

KnowledgeSpecification

Data Value Set Specification

CaDSR

Local M

etadata

BRIDG

Implem

entation Model -EF

Local Library O

DM

/CDASH

++

DIA PRESEN

TATION

2009

Knowledge Representation

Knowledge Acquisition

Expert

KnowledgeSpecification

Data

Data Representation

Data Value Set Specification

Concepts Structure

Content

USE CASE FO

R TOD

AY Patient Tracking and Specimen Collection and Processing

• Transactional systems , Workflow aware: allow the information in the system to support process automation, the more general the specification of activities, the less detailed the annotation.

– PVT– ImmunoTrak

DISCIPLIN

ES OF IN

FORM

ION

MAN

AGEM

ENT

Data Operations vs. Knowledge Management

Clean

Structure

Store

Collect

Dat

a C

lean

ing

Knowledge Representation

Knowledge Acquisition

Knowledge Delivery

Master Data Management

Transactional Systems Configuration

Data Annotation

Reporting

USE CASE

Clinical Data Integration

BRIDG Study Design

class View 2 - Study Design

Arm

+ description: ST+ name: ST+ randomizationWeightText: ST+ typeCode: CD

notesA path through the study which describes what activities the subject will be involved in as they pass through the study.

For example, a study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment, then Oral treatment.

NOTE: The group of subjects assigned to an Arm is often called a treatment group.

PlannedArm

+ targetAccrualNumber: INT

notesAn arm for which subjects have not yet been identified.

PerformedArm

notesAn arm which has had subjects identified and has already occurred.

StudyCell

+ blindedDescription: ST+ name: ST

notesThe association of a particular arm and epoch. It describes the activities the subject will be involved in for a particular epoch in a particular arm. The design of a study can be visualized as cells in a matrix whose columns are epochs and whose rows are arms; each cell of such a matrix is a study cell.

For example, in a crossover trial with two treatment epochs and three arms, there are six "treatment" study cells, one for each of the 2 treatment epochs in each of the 3 arms.

PlannedEpoch

notesAn epoch defined for a specific study but for which no subjects have been identified.

Epoch

+ description: ST+ firstEpochIndicator: BL+ name: ST+ typeCode: CD

notesA series of states that a subject passed through in their course of their participation in a study. Each Epoch serves a purpose in the trial as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Epoch-specific (state) transition rulescontrol the subject's movement from one Epoch to another.

For example, a study designed to assess the effects of treatments might have 3 epochs, a Screening epoch in which subjects' eligibility is determined and baseline measurements are made, a Treatment epoch during which treatments are given and effects of treatment are assessed, and a Follow-up epoch during which post-treatment assessments are conducted.

ScheduledEpoch

+ scheduledStartDate: TS

notesAn epoch defined for a specific study and subjects have been identified, but it has not yet occurred.

PerformedEpoch

notesAn epoch defined for a specific study in which subjects have been identified and has already occurred.

«StudyRelationship»EpochRule

notesRule that governs the transition between two epochs.

For example, if a subject experiences a serious adverse event while in the first treatment epoch, move to follow-up epoch.

For example, if there were entry and exit criteria that applied to all arms of a study.

«StudyRelationship»StudySegmentStudyCellRule

notesSpecifies how a study cell is related to one of the study segments instances it contains.

For example, if the plan for the Surgery Arm/Treatment Epoch studycell is that subjects should go through the three StudySegments, Pre-Op, Surgery, and Post-Op in that order, then that sequence is defined using StudySegment StudyCell Relationship instances.

For example, A StudyCell "Arm A/Treatment Epoch" may have StudySegments "A1", "A2", etc.. The sequence in which the different StudySegments will occur in StudyCell "Arm A/Treatment Epoch" will be defined by the semantics of the StudySegmentStudyCellRule class.

For example, go from surgery StudySegment to post-op StudySegment in StudyCell "Surgery Arm/Treatment Epoch".

PlannedStudySegment

+ plannedDuration: PQ

notesA study segment for which subjects have not yet been identified.

PerformedStudySegment

notesA study segment for which subjects have been identified and has already occurred.

StudySegment

+ description: ST+ firstStudySegmentIndicator: BL+ name: ST

notesA sub-state of an epoch that a subject passes through in the course of a study. They involve some intervention (possibly "no treatment") and an instance of a study segment serves all or part of the purpose of an epoch. Study segments never cross epoch boundaries; when a subject transitions from one epoch to another they must also transition from one study segment to another.

For example, the purpose of a treatment epoch might be accomplished by means of a single study segment (e.g., one which involves administering drug daily for 6 weeks) or by a complex pattern of study segments (e.g., a subject is to pass through study segment A, whichinvolves daily self-administration of drug X, then study segment B, which involves a single infusion of Drug Y, then study segment C, a 3-week "rest" period; the ABC sequence is repeated until disease progression or Serious Adverse Event X occurs. If X occurs, B is dropped and AC is repeated until disease progression).

Activity

+ categoryCode: CD+ comment: ST+ identifier: II+ nameCode: CD+ reasonCode: SET<CD>+ statusCode: CD+ statusDateRange: IVL<TS>+ subcategoryCode: CD+ textDescription: ST

notesAny action that can, in the context of a study, be planned, scheduled or performed.

For example, a surgical procedure, a laboratory test, or the administration of the drug.

NOTE: An activity may be related to other activities in arbitrarily complex ways using instances of ActivityRelationship.

ArmSoA

+ referenceTimePointText: ST

notesA portion of the schedule of activities (SOA) that is applicable to subjects in a particular arm. If a study has multiple arms, the arm-specific SOAs may be nearly identical (e.g., in a blinded controlled trial) or may be quite different (e.g., in a study that compares different modes of treatment).

NOTE: One could have other subsets of the SOA that are applicable to other groups of subjects. Some examples: Subjects who are or are not part of a correlative study, male subjects/female subjects, subjects in different strata if thestratum membership affects the SOA.

For example, most studies contain one ormore SOAs, (i.e. one SOA for each treatment arm) each in the form of a matrix of time (horizontal axis) and activities (vertical axis). (This matrix is therefore made up of individual cells anda SOA is defined by checking a cell, thereby associating a specific activity to a specific time).

«StudyRelationship»Activ ityStudySegmentRule

notesA rule that governs the transition to a new study segment based on the results of an activity in the current study segment.

For example, start the radiation study segment 2-4 weeks after surgery.

NOTE: If a subject is not in StudySegment A, then receiving a dose of Study Drug A is the activity that marks/defines their transition into StudySegment A.

StudySubject

+ actualSubjectIndicator: BL+ confidentialityIndicator: BL+ identifier: SET<II>+ paymentMethodCode: CD+ statusCode: CD+ statusDateRange: IVL<TS>+ subgroupCode: CD::Subject+ state: ST

notesAn individual who participates in a study either as a recipient of the investigational product or as a control. May also include individuals who are being screened for studies, or individuals participating in observational or other studies.

SoACell

notesRelates an activity to a particular encounter with a subject. The design of an encounter can be visualized as cells in a matrix whose columns are time points and whose rows are activities; each cell of such a matrix is an SOA cell; and an X in a particular cell indicates that an activity (row) is to takeplace at point in time (column).

For example, a CBC is to occur during the week 2 encounter.

SubjectStudyEncounter

+ name: ST+ typeCode: CD

notesA period of time (of non-zero duration) which is identified in the study protocol as a time during which a common grouping of activities are to take place.

For example, Clinic visit, Hospital admission, Telephone contact, Period of time during which a subject is to regularly self-administer medication, Period of time during which a subject is to "monitor Adverse Events", i.e., to note changes in their health status for reporting to the study investigator.

NOTE: Subject Study Encounters (SSE) may overlap. For example: A subject might be fitted with a Holter monitoring device during one clinic visit, then return to theclinic the next day to have the device removed. Each clinic visit is a Subject Study Encounter, and the 24-hour period during which the Holter monitor records data is another Subject Study Encounter. The Holter monitoring SSE overlaps with the first clinic visit SSE and may overlap with the second clinic visit SSE.

NOTE: Subject study encounters maybe nested within each other.

PlannedSubjectStudyEncounter

notesA subject study encounter for which subjects have not yet been identified.

ScheduledSubjectStudyEncounter

+ scheduledTiming: IVL<TS>

notesA subject study encounter for which subjects have been identified but it has not yet occurred.

PerformedSubjectStudyEncounter

+ performedTiming: IVL<TS>

notesA subject study encounter for which subjects have been identified and it has already occurred.

«StudyRelationship»SubjectStudyEncounterRule

notesSpecifies how to transition between subject study encounters.

For example, if the result of activity Aat Visit 2 is observation X, then the subject should return to the clinic three days after Visit 2 for a repeat ofactivity A.

For example, Visit 4 should take place 5-9 days after Visit 3.

Document

StudyProtocol

+ acceptsHealthyVolunteersIndicator: BL+ accrualReportingMethodCode: CD+ acronym: ST+ AECodingSystem: CD+ allocationCode: CD+ confidentialityCode: CD+ designConfigurationCode: CD+ diseaseCode: SET<CD>+/ multiInstitutionIndicator: BL+ participatingCountryCode: SET<CD>+ participatingOrganizationTypeCode: CD+ periodicTargetAccrualNumber: RTO<INT,PQ>+ phaseCode: CD+ plannedStudySubjectExperience: ST+ populationDescription: ST+ primaryPurposeCode: CD+ purposeStatement: ST+ responsiblePartyCode: CD+ studySchematic: ED+ subjectTypeCode: CD+ targetAccrualNumberRange: IVL<INT>+ targetAnatomicSiteCode: CD

notesAn action plan and execution of a pre-clinical or clinical study including all activities to test a particular hypothesis that is the basis of the study regarding the effectiveness of a particular treatment, drug, device, procedure, or care plan. This includes prevention, observational, therapeutic, and other types of studies that involvesubjects.

NOTE: The StudyProtocol class encapsulates the semantics of two 'views' of the single concept 'study.' The name 'StudyProtocol' was chosen to both disambiguate the somewhat overloaded term 'protocol,' as well as to emphasize that the class has two important relationships to the Document class, each of which emphasizes a different aspectof the overall semantics of the StudyProtocol class:1). StudyProtocol is a sub-class of the Document class:StudyProtocol is a sub-class of Document and, as such, inherits all of the basic characteristics of its parent. In particular, an instance can contain all of the definitions, specifications, and content of the various (logical) documents which collectively define a study, including (but not limited to) documents that describe the objective(s), background, and/or plan (including the design, methodology, statistical considerations, organization, or other supplemental materials that describe the required information of a Study.2). StudyProtocol is a collector for Document instances:StudyProtocol is a collector for all various artifacts (including the protocol itself) which collectively define a study, including (but not limited to) specifications of planned, scheduled, or performedActivities, ObservationResults, Assessments, Analyses and their various inter-relationships.

NOTE: A StudyProtocol can be either Primary or Correlative. A StudyProtocol is considered to be Primary if it has one or more Correlative studies associated with it. A Correlative study extends theobjectives or observations/conclusions of a Primarystudy, enrolling the same (or a subset of the same) subjects as were enrolled in the Primary study. (Correlative Studies are not modeled in BRIDG yet.)

NOTE: We are assuming that a document is a container, which may be physical or logical, with the six characteristics listed in the definition of theDocument class. This class is the container for thePlan.

NOTE: StudyProtocol describes the pre-study, study, and post-study portions of the plan.

ScheduledStudySegment

notesA study segment for which subjects have been identified but has not yet occurred.

HL7 RIM Entity

HL7 RIM Role

HL7 RIM Participation

HL7 RIM Act

HL7 RIM ActRelationship

Placeholder

Draft

Legend

RandomizationBookEntry

+ positionFilledIndicator: BL+ positionNumber: INT

notesAn item/element of a randomization book that can beused to assign a patient to a planned study cell of a study.

For example, an entry might be mapping Stratum Group to a Treatment Arm.

PlannedStudyCell

notesA study cell for which subjects have not yet been identified.

StratumGroup

+ groupNumber: INT

notesA designation used tosegregate study subjects into collections in order to balance the study for analysis. The stratum group is made up of a combination of stratification criterion answers, which ultimately is used to assign subjects to arms on a study.

«StudyRelationship»StratumGroupRelationship

notesAn individual membership of one criterion value in a stratum group.

For example, StratumGroup "Men" may be associated to PlannedStratificationCriterionPermissibleResult "Male" and also "18 and over" while StratumGroup "Boys" may be associated to PlannedStratificationCriterionPermissibleResult "Male" and also "under 18".

PlannedStratificationCriterion

+ criterionCode: CD

notesSelected pre-treatment factorsby which patients are segregated to assure balanceof these factors before randomization to the planned study cell of a study protocol.

PlannedStratificationCriterionPermissibleResult

notesAn allowable response to a stratification criterion.

For example, the stratification criterion for gender can have permissible answers of male and female.

PlannedObservation

notesThe intended action of observing, monitoring, measuring or otherwise qualitatively or quantitatively gatheringdata or information about one or more aspects of a subject's physiologic or psychologic state.

PlannedActiv ity

+ actualIndicator: BL+ additionalDurationDescription: ST+ contingentIndicator: BL+ inStudySegmentPlannedActivityTypeCode: CD+ name: SET<ST>+ plannedRangeOfRepetitionsText: ST+ studyFocusIndicator: BL

notesAn activity that is anticipated to occur at some time in the future.

For example, pregnancy tests are planned for studysubjects who are females of childbearing potential. The pregnancy tests are in the future, and the particular women who will be tested have not beenidentified.

NOTE: A planned activity could also be thought of as an activity at a particular stage in the business process in which the activities occur, i.e., in the "planned" stage rather than the "scheduled" stage or the "performed" stage. An instance of a planned activity is not assigned to a particular study subject, but to a "kind of" study subject.

PlannedObservationResult

+ targetCodingSystem: CD

notesThe intention to obtain a result by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes.

ObservationResult

+ baselineIndicator: BL+ booleanResult: BL+ comment: SC+ confidentialityCode: CD+ numericResult: PQ+ reportedDate: TS+ resultCode: CD+ targetSiteCode: CD+ textResult: ST+ uncertaintyCode: CD

notesThe finding obtained by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes.

For example, in a clinical trial, observations can result from planned activities to address specific questions such as those observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires.

NOTE: Not all observationsare necessarily planned -- for example, some observations may be laboratory tests that are done in response to patient occurrences that are not planned but used to assess patient symptoms.

NOTE: An observation may be a symptom that a patientexperiences that, in the context of a particular clinical trial, will be assessed as adverse.

DefinedEpoch

notesAn epoch that frequently occurs in studies (e.g. more than one time in more than one arm) and therefore is called out as a reusable template, and is independentof any one study.

Subject

+ state: ST

notesAn entity of interest, either biological or otherwise.

For example, a human being who might be of interest because they are on a study, or asheep who might have experienced an adverse event.

NOTE: This is to support potential candidates for a study.

ScheduledArm

::Arm+ description: ST+ name: ST+ randomizationWeightText: ST+ typeCode: CD

notesA scheduled path through the study which describes, epoch by epoch, what activities the subject will be involved in as they pass through the study.

For example, a study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment, then Oral treatment.

NOTE: The group of subjects assigned to an Arm is often called a treatment group.

PlannedEligibilityCriterion

+ criterionCode: CD+ criterionName: ST+ displayOrder: INT+ operator: ST+ requiredResponse: ST+ value: ST::PlannedActivity+ actualIndicator: BL+ additionalDurationDescription: ST+ contingentIndicator: BL+ inStudySegmentPlannedActivityTypeCode: CD+ name: SET<ST>+ plannedRangeOfRepetitionsText: ST+ studyFocusIndicator: BL::Activity+ categoryCode: CD+ comment: ST+ identifier: II+ nameCode: CD+ reasonCode: SET<CD>+ statusCode: CD+ statusDateRange: IVL<TS>+ subcategoryCode: CD+ textDescription: ST

notesAn intended characteristic or requirement which helps determine whether a potential subject can beenrolled in a study.

PlannedExclusionCriterion

::PlannedEligibilityCriterion+ criterionCode: CD+ criterionName: ST+ displayOrder: INT+ operator: ST+ requiredResponse: ST+ value: ST::PlannedActivity+ actualIndicator: BL+ additionalDurationDescription: ST+ contingentIndicator: BL+ inStudySegmentPlannedActivityTypeCode: CD+ name: SET<ST>+ plannedRangeOfRepetitionsText: ST+ studyFocusIndicator: BL::Activity+ categoryCode: CD+ comment: ST+ identifier: II+ nameCode: CD+ reasonCode: SET<CD>+ statusCode: CD+ statusDateRange: IVL<TS>+ subcategoryCode: CD+ textDescription: ST

notesA characteristic or requirement intended to be applied to a potential subject to determine whetherthey may not participate in a study.

For example, pregnancy.

PlannedInclusionCriterion

::PlannedEligibilityCriterion+ criterionCode: CD+ criterionName: ST+ displayOrder: INT+ operator: ST+ requiredResponse: ST+ value: ST::PlannedActivity+ actualIndicator: BL+ additionalDurationDescription: ST+ contingentIndicator: BL+ inStudySegmentPlannedActivityTypeCode: CD+ name: SET<ST>+ plannedRangeOfRepetitionsText: ST+ studyFocusIndicator: BL::Activity+ categoryCode: CD+ comment: ST+ identifier: II+ nameCode: CD+ reasonCode: SET<CD>+ statusCode: CD+ statusDateRange: IVL<TS>+ subcategoryCode: CD+ textDescription: ST

notesA characteristic or requirement intended to be applied to a potential subject to determine whetherthey may participate in a study.

For example, must be over the age of 18.

«StudyRelationship»Activ ityRelationship

notesThe semantic link between activities.

For example, measure blood pressure before taking a pharmacokinetics sample.

NOTE: An activity relationship might be sequential in that one activity precedes another activity. There may also be activities that have different priorities and this helps determine which activity to choose in the case of limited resources.

NOTE: Trial Design Model Activity Rule: A rule which controls when or whether an Activity is to be performed based on the performance or result of another Activity. For example, measure blood pressure before taking PK sample.

View Description:This View is a representation of the CDISC Trial Design Model (TDM) and NCI's Cancer Central Clinical Participant Registry (C3PR) Model. Because of the complexity (and importance) of this model - it is the basis for defining a computable representation of a study design - the THC has included several instance diagrams on the subject.

The different views of the design, the state-based view and the control-thread view, are described in the BRIDG Project Documentation and Release Notes for R1.1.

«StudyRelationship»ObservationResultRelationship

notesSpecifies the link between observation results.

For example, a particular test may be a component of a larger panel of tests, so the relationship between the individual test and the panel is that one is a component of the other.

0..*

may be thesource for /associatesfrom

1

1

contains theactivities for /is described by

1

0..1

identifies thetimeslot for / isplanned within

1

1..*

1

1..*

categorizes / iscategorized by

1

0..*

associates from /may be containedby

1

1

identifies eventsfor / has

0..*

1..*

groups / is groupedby

1

1..*

groups / is groupedby

0..1

1may be thecontainer of /associates to

0..*

1

associates from /may be thesource for

0..*

1..*

associates to / isa component of

1

1

is used to createa /subject-specificdescription of

0..*

0..*

may be the target for/ associates to

1

1

is fulfilled by /is theinstantiation of

0..1

1

is used to createa / is asubject-specificdescription of

0..*

1..*

is comprised of /is a componentof

0..1

1..*

is a component of/ is comprised of

1

1

is operationalized by /is described by

0..*

1..*

is a division of /is divided into 1

1..*

is comprised of /associates from1

0..*

associates from /may be the source for1

0..*

associates to /may be thetarget for1

0..*

associates from /may be the sourcefor

1

1

is operationalized by /is described by 0..1

0..1

participates in / isperformed for

0..*

0..1

is used to create a /is a study-specificdescription of

0..*

0..*

is defined by /defines

1

1

associates to /may be thetarget for

0..*

0..*

associates to / may be thetarget for

1

1

is defined by /defines

1..*

1

is defined by/defines

1..*

1

is randomized by /identifies a cell for

0..*0..*

is randomized by /randomizes

1

1

is fulfilled by / isthe fulfillment of

0..1

Name:Package:Version:Author:

View 2 - Study DesignBRIDG Release 2.1 -- Static Classes2.1BRIDG THC

Activity

Epoch

StudyCell

Arm

Arm SOA

Protocol

Subject

Subject Encounter

Segment

META

DATA

MAN

AGE

MEN

T –

ISO

1179

Data ElementConcept

Conceptual Domain

Data element Value Domain

Perception

Representation Concrete

Abstract

0..* 1..1

0..* 1..1

0..

*

1

..1

0..

*

1

..1

Data Element

Perception

Measure

Associated

or not Domain

Interventional S

tudy

Observational

Study

Expanded A

ccess S

tudy

Study P

rotocol

Study P

rotocol

National Institute of Allergy & Infectious Diseases

Funded by:

Juvenile Diabetes Research Foundation National Institute of Diabetes & Digestive & Kidney Diseases