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Refresher: What is a DAM?
• Domain Analysis Model (DAM)
• An implementation-independent view of domain of interest
• Represents a shared understanding of concepts
• Uses domain terminology and is readable by domain experts
• Has unambiguous definitions
• Uses complex data types designed specifically for healthcare concepts
• Follows good modeling practices
• Enables interoperability when systems share a common understanding
• Is built by analysts and subject matter experts who develop consensus
1
Major Concepts/Areas in BRIDG
Documents
Study Design
Study Subjects,
People &
Roles
Protocol
Organizations
& Roles Study Activities,
Observations &
Results
Specimens
Specimen
Collection
Products &
Study Agents
2
Layered Models
Domain Analysis Model
Project Analysis Model
MAKE NO MISTAKE
Information Model
The primary goal is
to get here
Implementable/Functional Model
Platform Model Platform Model Platform Model
Implementation Implementation Implementation
s ms i n a hc e Mtc at n oc- l edo M si syl anA R P 3C s s al c
rot agit s e vnIydut S noit ailiffApuorGrot agit s e vnI eti S
m sin ah c e Mt c atnoC puorGrot agit s e vnI
*.. 0 no sr e P
etaD. l it u. av a j : et aD d n e - em i T et a d : et aD d n e -
Activity/Act
gn irt S. g n a l. av a j : e pyt -
1
gn irt S. g na l. av a j : e m aNtsr if - gn irt S. l it u. av a j : e d oC e l or - em i T et a d : et aDtr ats - *.. 0 1 g n irts :tx e T n o it p ircs e d -
gn irt S. gn a l. av a j : e u l av - na e l o o b :r ot ac i d nI er ut a n g is - em i T et a d : et aD d n e -
BRIDG/ RIM
gn irt S. g n a l. av a j : e m aNts a l -
gn irt S. lit u. av a j :tx e T er ut a n g is - s r ot a g its e v nIy d uts- g n irts : e m a n -
gn irt S. gn a l. av aj : e m aN n e d i a m - *.. 0 sn o it a i l iff A p u orGrot a g its ev nI et is-
etaD. l it u. av a j : et aDtr ats - em i T et a d : et aDtr ats -
+units
gn irt S. g n a l.av a j : e m aNe l d d i m - rot a g its ev nI et i S er ac ht l a e h-
g n irt S. g n a l. av a j : e d oCs ut ats - 1 rot a g its ev nI et i S er ac ht l a e h-
date: j ava.uti l .Date - date: j ava.uti l .Date -
*.. 0
4
*.. 0
rot agit s e vnI s r ot a g its e v nIy d uts-
1
1.. 0 *.. 0
BRIDG/ RIM Participation
1 rot agit s e vnI eti S er a chtl a eH Canceled name: j ava.l ang.Stri ng -
na ic isy h P g n it a ert-
Occurred Scheduled
gn irt S. gn a l. av a j :r e if it n e dI ic n - r ot a g its ev n i- DC : e d oCs ut a ts - 1
rot a g its ev nI et i S er ac ht l a e h- scheduledev entstate::
cit at S -- 1. 1. 1 e s a el eR GDIRB e m i T et a d : et aDs ut ats -
scheduledev entstate:: scheduledev entstate:: displayName: String +
mr Ad elud eh c S:: s e s s alC ss e r d d a-
Activ ityType +labTestId
1 1 *.. 0 cit at S -- 1. 1. 1 e s a el eR GDIRB BRIDG/ RIM Role
f f at Sh cr a e s eRl a cinilC e ti S er aChtl a eH:: s e s s alC
codeSystemVersion: String +
T S : n o it p ircs e d +
s s erddA
TS : e m a n + gn irts :r e if it n e dI ic n - *.. 0 1 II :r e if it n e d i +
codeSystemName: String +
et i Sy d uts-
+type 1 commentsFromInvestigator: String +
TS :t h g i eW no it az i m o d n ar + gn irt S. g n a l. av a j :yt ic - eti S er ac ht l a e h- D A :ss er d d A l ats o p +
0..* 1
1 1 f f at S hcr a es er-
materialType
gn irt S. g n a l. av a j : e d oCyrt n u oc - 1..* commentsFromLaboratory: String + codeSystem: String + BRIDG/RIM Entity
gn irt S. g n a l. av a j : e d oC l ats o p - et i Sy d uts-
eti S ydut S 1
gn irt S. g n a l. av a j : e d oC et ats -
uni ts: j ava.l ang.Stri ng - condition: String code: String +
*.. 0 l e n n osr e Py d uts-
+specimenCollection +
*.. 0
+materialType
g n irt S. g n a l. av a j :ss er d d At e erts - etaD. l it u. av a j : et aD d n e - id: Integer +
*.. 0
quanti ty: j ava.l ang.Integer -
l enno sr e P ydut S
accessionNumber: String +
etaD. l it u. ava j : et aD lav or p p A br i -
1 ss e r d d a-
gn irt S. g n a l. ava j : e d oC e l or -
units
et i Sy d uts- em i T et a d : et aD d n e -
name: j ava.l ang.Stri ng -
1
identifier: String +
gn irt S. l it u. av a j : et aDtr ats -
reason: j ava.l ang.Stri ng -
t n i : e d oC e l or -
Duration
ro snop SgnidnuF ydut S tn i :r e b m uNl a urcc At e gr at
ConceptDescriptorDataType
1 - 1 descri pti on: j ava.l ang.Stri ng -
*.. 0 em i T et a d : et aDtr ats
labTestId
n oit azin agrO -
id: Integer +
et Sy s u
*.. 0 1 s e t i Syid utd- ts- g n i rts : e d oCs ut ats -
l e n n osr e Py d uts-
scheduledeventstate::ScheduledEventState
: : s e s s alC cit at S -- 1. 1. 1 e s a el eR GDIRB gn irt S. g n a l. av a j :tx e Tn o it p ircs e d -
mr Ad enn al P gn irt S. g n a l.av a j : e m a n -
1 +durati on Activ ity Specimen 1 +race 1 +gender HealthCareSite
gn irt S. g n a l. av a j : e d oC et ut its nI ic n -
T S : n o it p ircs e d + : : s e s s alC cit at S -- 1. 1. 1 e s a el eR GDIRB
1 no it az i n a gr o- t n em uc o D
+states
TS : e m a n + y dut Sd enn al P {ordered}
cit at S -- 1. 1. 1 e s a el eR GDIRB
1
TS :t h g i eW no it az i m o d n ar +
s i / f o n o is iv i d a s i TS : n o it ar uDn o it n evr et nItce j b u S d e n n a l p +
+acti vi ty
lo cotor P ydut S:: s e s s alC
+specimen 1 +specimenCollection 1..*
TNI : l a urcc At e gr at +
1..* 1 +healthCareSite
otn i d e d iv i d *.. 0 s n o it az i n a grOy d uts- TS : n o it ar uD n oit a p ic itra Ptc e j b uS d e n n a l p +
* .. 1 1
TNI : l a urcc At e gr at + LB :r ot ac i d nI d e d n i l b + 1
noit azin agrO ydut S l oc ot or Py d ut S:: DC : a m e hcS g n i d n i l b + +labResultCollection 0..*
LB :r ot ac i d nI d e d n i l b + DC :yt i l a it n e d if n oc + +pl annedEvent
DC : a m e hcS g n i d n i l b + DC : es a es i d +
1.. 0 t n api citr a P DC :yt i l a it n e d if n oc + DC :t n et n i + race gender
DC : es a es i d + DC :r ot i n o m +
day: i nt - referenceFlag: String +
-- 1. 1. 1 e s a el eR GDIRB gn irt S. g n a l. av a j : e doCr e d n eG evit arts i n i m d a - 1..1 +specimenCollection
a s i / f o d es ir p m oc s i : : s e s s alC cit at S etaD. l it u. av aj : et aD htr i b - DC :t n et n i + LB :r ot aci d nI n o it ut its nI it l u m +
typeModifier: String +
*.. 0 s n o it az i n a grOy d uts- sr et n eC g n it a n i dr o oCy d uts-
f o t n e n o p m oc DC :r ot i n o m + DC : e s a h p + y d u ts-
testPerformedDateTime: Date +
h cop Ed enn al P gn irt S. l it u. av a j : e d l oC p uorGc i n ht e - r etn eCgnit anidrooC ydut S +subjectAssignmentCollection 0..* +studySiteCollection
LB :r ot aci d nI n o it ut its nI it l u m + s
TS : n o it p irc eD n o it a l u p o p +
PlannedEv ent plannedIndicator: Boolean +
gn irt S. g n a l.av a j : e d oCsut at S l at ir a m - 1
notes: j ava.l ang.Stri ng -
d et a n i dr o oc s i *.. 0 DC : e d oCyt i l i b is n o ps er -
reportedResultStatus: String +
T S : n o it p ircs e d + DC : e s a h p + LB :r ot ac i d nI d ez i m o d n ar +
method: String +
* .. 1 gn irt S. g n a l. av a j : e d oC ec ar - / yb
L B :r ot ac i d nI hc o p Etsr if + s
TS : n o it p irc eD n o it a l u p o p + DC : e py Ttc e j b us +
i deal Date: j ava.uti l .Date - reason: String + 0..* 1
s e t a n i dr o oc
startDay: j ava.l ang.Integer - referenceTextList: String +
/ f o t n e n o p m oc a s i TS : e m a n + LB :r ot ac i d nI d ez i m o d n ar + t n em uc o D ::
fastingStatus: String +
1 r
tn a p ic it1a p-
+ studySubjectIdentifier: String
-- 1. 1. 1 e s a el eR GDIRB 1..* +pl annedEvents +labTest 0..* +labTestCollection 0..*
f o d es ir p m oc s i DC : e pyt + y d u ts- y d u ts- DC : e py Ttc e j b us + TS : n o it p ircs eD d e l i at e d +
plannedTimeElapsedDescription: String + + id: Integer
: : s e s s alC cit at S * .. 1 1 1
repeti ti ons: i nt - referenceRangeComments: String +
t n em uc o D :: >II< T E S :r e if it n e d i +
subjectAgeAtCollectionUnits: String +
1
ScheduledEv ent + type: String
ll eC ydut Sd enn al P
TS : n o it p ircs eD d e l i at e d + DC : e g a u g n a l +
name: j ava.l ang.Stri ng - referenceRangeHigh: Integer + plannedTimeElapsed: String 0..* + 1 +studySite
TS : n o it p ircs eD d e d n i l b + >II< T E S :r e if it n e d i + T S : n o is iv er +
studyScheduledIndicator: Boolean + subjectAgeAtCollection: Integer + + id: Integer
y dut S
+peri od StudySite
TS : e m a n + DC : e g a u g n a l + DC :s ut a ts + referenceRangeLow: Integer + actualEndDateTime: Date +
+schedul edEvents 1..*
g n irt S. g n a l. av a j : n o isr e Vt n es n oc -
studyDefinedIndicator: Boolean + id: Integer +
T S : n o is iv er + > S T< L VI : e g n aR et aDs ut ats +
Period +subjectAssignment
h cop E gn irt S. g n a l. av a j :tx e Tn o it p ircs e d - 1. 1. 1 e s a el eR GDIRB
actualStartDateTime: Date +activityCollection +
DC :s ut a ts + >DC< T E S : e pyt b us +
SubjectAssignment
:: s e s s alC cit at S --
textResult: String + comments: String +
tn i : gn i l i eCl a urcc a - gn irt S. g n a l. av a j :tx eT e lt iT g n o l - > S T< L VI : e g n aR et aDs ut ats + TS : n o it p ircs eDyr a m m us +
0..* 0..*
ro snop S ydut S
1 identifier: String +
g n irts :tx e Ts ic er p >DC< T E S : e pyt b us + T S :s is p o nys +
SpecimenCollection
na e l o o b :r ot ac i d nI l a urcc a - - yd ut S n o i n a p m oc- si
numericPrecision: Integer 0..1 +
mrA
1..* additionalTestDescription: String +
n a e l o o b :r ot ac i d nIt n es n oc - DC : e d oC e d o Mn o it az i m o d n ar - TS : n o it p ircs eDyr a m m us + TS :e lt it + d e r os n o ps DC : e pyt +
1
id: Integer + +studySiteCollection
g n irts :tx e T n o it p ircs e d - g n irts :tx e T n o it p ircs e d - gn irt S.g n a l. av a j :tx e T e lti Ttr o hs - 1 T S :s is p o nys + DC : e pyt + 1 / yb * .. 1 +peri ods numericResult: Integer + status: String + +subjectAssignment 0..1 +studySiteCollection
gn irt S. g n a l.av a j : e m a n - * .. 1 1 na e l o o b :r ot ac i d nIt n e m l l or n e - g n irt S. g n a l. av a j : e d oCr os n o ps - TS :e lt it + s r os n o ps
1 +schedul edArm 1 +arm +labResult
DC : e pyt +
0..*
tn i :r e b m uNl a urcc At e gr at - t n i :r e drO hc o p e -
name: j ava.l ang.Stri ng - id: Integer + id: Integer +
1 1 -
t n er a p1 y d u ts-
Activity
gn irt S. g n a l.av a j : e m a n -
1
1..* 1
na e l o o b :r ot aci d nI d ez i m o d n ar - 1 +labTest +specimenCollection
1 n a e l o o b :r ot ac i d nI n o it avr es er - de if it n e d i
Epoch LabResult
*.. 0 st n e m d n e m Ay d uts-
LabTest
na e l o o b :rot ac i d nI n oit ac if it arts - / n i s et a p ic itr a p e s a e siD ydut S
name: j ava.l ang.Stri ng 1 -
s e if it n e d i/y b +epoch
+arms
na e l o o b :r ot ac i d nIt n e mt a ert - n o it a p ic itr a p s a h s es a es iDy d u ts-
sre if it n e d i-
startDate: j ava.uti l .Date -
fo n a e l o o b : es a es iD d a e l -
*.. 0 *.. 0 sre if it n e d i-
tn emdn em Aydut S
+arm
1
1..* +epochs
* .. 1 * .. 1
Arm 0..* +labResultCollection +labTestCollection 0..* +labTest 1
1 1 etaD. l it u. av a j : et aDt n e m d n e m a -
ScheduledArm 1 +study
s n o it a ic oss Ay d ut S n o i n a p m oc- : : s e s s alC cit at S -- 1. 1. 1 e s a el eR GDIRB 1.. 0 es a es iD y d uts- 1 y r o g et aC es a es i d-
s
gn irt S. g n a l. av a j : n o i r e Vt n e m d n e m a - r eifitn edI
+investigatorCollection
*.. 0
1.. 0 no it az im o d n ar- gn irt S. g n a l. av a j :st n e m m oc - 1 t c e jbu Sydut S +participant 1
na e l o o b :yr a m ir Ps i -
0..*
1
g n irts : e pyt - LB :r ot ac i d nItc e j b u S l a utc a + *.. 0 s e ir o g et aC d l i hc-
+schedul edArms 1..*
noit ai co s s Aydut Snoin apmoC
+ assigningAuthority: String
>II< T E S :r e if it n e d i +
+pl annedSchedul e
n oit azimodn aR g n irts : e u l av -
na e l o o b :r ot ac i d nIyr ot a d n a m - T S : et ats + y rog et aC e s a e siD
airet irCyt i li bi g il e-
+ name: String
*.. 0
DC :s ut a ts +
1.. + name: String
gn irt S. g n a l.av a j : e m a n -
1 +schedul edCal endar
*.. 0 > S T< L VI : e g n aR et aDs ut ats +
+ identifier: String
r eifitn edId engi s s Am et sy S yr o g et aCt n er a p-
+ identifier: String
DC : p u o r g b us +
noir etirC ytilibigil E 1.. 0
+ id: Integer
g n irts : e m aN m etsys -
1 1 yr o g et ac-
de if it n e d i
na e l o o b :rot ac i d nI e lb ac i l p p At o n -
+performingLaboratory 0..1 0..1 +centralLab
s e if it n e d i/y b
Participant Investigator
DC :r e b m uN n o its e u q -
1 1
r eifitn edId engi s s Anoit azin agrO y rot siH e s a e siD
compl ete: bool ean - Study
noit azimodn aR kooB
name: j ava.l ang.Stri ng -
gn irt S. g n a l. av aj :tx e T n o its e u q - *.. 0 s tc e j b u Sy d uts-
n oit azimodn aRll aC enoh P
gn irt S. g n a l. av a j : e doC es a es iDyr a m ir Pr e ht o -
in this phase
1 y r ots iH es a es i d-
personId: j ava.l ang.Stri ng -
g n o l :r e b m uN e n o h p - gn irt S. g n a l. av aj : e d oC et i S es aes iDyr a m ir Pr e ht o -
e
+pl annedSchedul+study PlannedCalendar
air et irCn o it ac if it arts- no ir etirCyt il i bi g il e- t c e jbu Sydut S
ScheduledCalendar Study
1 1.. 0
l astName: j ava.l ang.Stri ng - implementing it
s
em i T et a d : et aD d e n g i St n e n oC d e mr of n i -
+personCollection +personCollection
*.. 0 1 s mr et-
CentralLaboratory
1 1.. 0 et i S es a es i d- * .. 1
gender: j ava.l ang.Stri ng - PerformingLaboratory
1.. 0 g n irts : n o isr e Vt n es n oC d e mr of n i -
we are not
em i T et a d : et aDy d ut Sff o -
+study 1
s tc e j b u Sy d uts-
fi rstName: j ava.l ang.Stri ng - 0..* 0..*
n oir etirCnoit a cifit art S g n i rts :tx e T n os a eRy d ut Sff o - eti S cimot anA mr e T e s a e siD
removed since
se irt n E n o it az i m o d n aRk o o b- em i T et a d : et aDtr ats -
*. -
stce j b u Sy d ut S d l i hc. 0
bi rthDate: j ava.uti l .Date -
DC :tx e T n o its e u q - gn irt S. g n a l. av a j :yr o g et ac - gn irt S. g na l. av a j : mr e T p etc -
class has been
*.. 0 * .. 1 *.. 0 tn i :r e b m uN p u orG m ut arts -
noir etirC ytilibigil Enoi sul c x E noir etirC ytilibigil Enoi sul cnI gn irt S. g n a l.av a j : e m a n - gn irt S. g n a l. ava j : e d oC ar d e m -
gn irt S. g na l. av a j :r e if it ne dIt n a p ic itr a Py d uts - 1 +studyParti ci pantAssi gnment + initials: String
r e w snAytilibigil Et c e jbu S gn irt S. gn a l. av aj : mr et -
Interpretation
yrtn Enoit azimodn aR kooB gn irt S. g na l. av a j : n a ic isy hP g n it a ert - Participant
no ir et irC n o it acif it arts-
1
1 + dateOfBirth: Date
gn irt S. g n a l. av a j :tx e Tr ews n a - s hc o p Et n e mt a er T d e l u d e hcs-
t n i : n o it is o p - 1 tc e j b u Sy d ut St n er a p-
NOTE:
1
name: java.lang.String -
1 + id: Integer
h cop Ed elud eh c S
srews n Ayt i li b i g i l Etc e j b us- *.. 0
+parti ci pant
yrt n E n ot az i m o d n aRk o o b- *.. 0
*.. 0 1 t n i : n o it is o Pt n err uc - studyParti ci pantIdenti fi er: j ava.l ang.Stri ng -
1 gn irt S. g n a l. av a j :txe T n os a eR l av or p p as i d -
1..* Person
na e l oo b :r ot aci d nIyt i l i bi g i l e -
startDate: j ava.uti l .Date -
p u orG m ut arts- r e w snAnoit a cifit art St c e jbu S sr ews n A n o it ac if it art Stc e j b us- s r ews n A e l bss i mr e p- gn irt S. l it u. av a j :tx e Tn os a eRr ev iaWyt i l ib i g i l e -
1 *.. 0 s p u o rG m ut arts- *.. 0
+studyParti ci pantAssi gnments
*.. 2 1 etaD. l it u. av a j : et aDtr ats -
*.. 0 StudyParticipantAssignment
p uorGmut art S rews n A n o ir et irCn o it ac if it arts- 1
t n i : n o it is o Pt nr err uc - 1 1 r e w snA elbi s simr e Pnoir etirCnoit a cifit art S
Study
tn i :r e b m uN p u orG m ut arts - gn irt S. g n a l. av a j :r ews n A e l b iss i mr e p -
1..* 11/20/2006 4:37:35 PM + name: String Updated:
mr Ad elud eh c S 1 8/8/2006 2:03:19 PM + identifier: String Created:
1
1 na e l oo b :r ot aci d nIyt i l i bi g i l e - + id: Integer
gn irt S.g n a l. ava j : nos a eRr ev i aWyt i li b i g i l e -
1.0 Version:
s mr A d e l u d e hcs-
no it a n i bm oCr ews n An o ir et irC n o it acif it arts- gn irt S. g n al. av a j :r e b m uNt ik - 1..*
etaD. l it u. av a j : et aDtr ats
ScenPro, Inc. Author:
- *.. 0 1.. 0..* Organization
* .. 1 * .. 1
name: j ava.l ang.Stri ng - Lab Model Name:
+studysi tes
noit anibmoCr e w snAnoir etirCnoit a cifit art S
+si
+studySi teCol l ecti on te
Site
*.. 0
StudySite
cd Lab Model
cd PSC
cd Patient Study Calendar
C3PR Patient Study Calendar Lab Model/caXchange
sponsorCode: java.lang.String - assigningAuthority: String +
shortTitleText: java.lang.String - name: String +
randomizationModeCode: CD - identifier: String +
Implementation Specific Models
precisText: string - id: Integer +
longTitleText: java.lang.String -
descriptionText: java.lang.String - Study
consentVersion: java.lang.String -
Study cd Lab Model -DRAFT
class C3PR Analysis Model
targetConditionCode: BRIDGCodedConcept +
0 ..1
P e rformingLa bora tory
0 ..1
subjectType: BRIDGCodedConcept +
0 ..1
Ce ntra lLa bora tory
E x a mina tion Othe rFindings La bRe s ult
0 ..1
status: BRIDGStatus +
V ita lS ign
Inte rpre te dRe s ults
Te stIn te rp re ta ti o n
S DTM Finding
e q u i va l e n t.
Ob s e rva ti o n -- th e y a re se m a n ti ca l l y
S DT M Fi n d i n g ca n b e re p l a ce d b y
sponsorCode: BRIDGCodedConcept +
Qua ntita tiv e M e a s ure me nt
1 ..*
S pe c ime n Inte rpre ta tion
Obs e rv a tion 0 ..1
1
randomizedIndicator: boolean +
1 1 ..1
0 ..* 1
1
S pe c ime nColle c tion 1
As s e s s me nt
La bTest 0 ..*
populationDescription: BRIDGDescription +
0 ..* 1
0 ..*
As s e s s me ntRe la tions hip
P roc e dure
multiInstitutionIndicator: boolean +
0 ..* 1
Clinic a lRe s ult
S c he dule dArm
a cre a te to descri p ti o n +i f
o s used su b j e ct-sp e ci fi c +i s a P la nne dArm
1 ..* 0 ..*
monitorCode: BRIDGCodedConcept + +co n ta i n
0 ..* 1
of descri p ti o n cre ae ct-s
su b j te a p e ci fi c e d to
+i s u s +i s a
1 P la nne dE v e nt
P e rforme dObs e rv a tion E ve n t wi th i n co n ta i n e d +a re
1 of co m p o sed +a re
intentCode: BRIDGCodedConcept +
1
0 ..* +co m p o se
+so u rce
0 ..* De v ic e Drug
S c he dule dE v e nt The ra pe utic Age nt
1
E ve n t Re gis tryS te w a rd::
Obs e rv a tionRe la tions hip S tudyDe s ignE poc h
+h a ve
blindedIndicator: boolean +
to a ttri b u te d
0 ..*
S c he dule dCa le nda r +a re
in used +a re
a cre a te to +i s u sed M a te ria lRole +h a ve M a te ria l
1 1 1
0 ..* +d e scri b e s +wri te
+ta rg e t Doc ume nt La bora tory
type: BRIDGCodedConcept +
S tudy Doc ume nt
P la nne dS tudy
0 ..* 1 by +i s d e scri b e d of descri p ti o n su b j e ct-sp e ci fi c +i s a
1 ..1 1
P e rforme dS ubj e c tAc tiv ity
S c he dule dE v e ntAc tiv ityRe la tions hip +ta rg e t +so u rce by +i s d e scri b e d 1 FundingS pons or
He a lthCa re S ite
S c he dule dAc tiv ity
by +i s o p e ra ti o n a l i ze d
P la nne dCa le nda r
phaseCode: BRIDGCodedConcept +
0 ..* 0 ..*
0 ..1 1
1 1 0 ..*
to a ttri b u te d
a cre a te to +i s u sed
+a re
1 S tudyAge nt
1
+h a ve
Orga niza tionRole Orga niza tion
description: BRIDGDescription +
S ubj e c tAs s ignme nt 0 ..1 1
1
0 ..1 by +i s o p e ra ti o n a l i ze d s
+a s i g n 0 ..*
+s s
tu d yP a rti ci p a n tA s i g n m e n t
S tudyS ubj e c t P a rtic ipa nt
Per fo r med Stu d y
longTitle: string +
of descri p ti o n su b j e ct-sp e ci fi c +i s a by as i gned
s +a re
P e rforme dAc tiv ity
1 0 ..*
1 ..1 1 by +i s d e scri b e d by wri tte n +a re
1 1
0 ..* 0 ..*
P la nne dObs e rv a tion S tudyAuthor Inv e s tiga tor to a ttri b u te d
P la nne dAc tiv ity +a re
altTitle: string +
1
1 in 1 ..*
+p a rti ci p a te 0 ..* 1
S tudyS ite P e rs onRole +h a ve
P e rforme dAc tiv ityRe la tions hip at p e rfo rm e d +a re
S tudy P e rs on
CTOMA cti vi tyA cti vi tyRe l a ti o n sh i p th e ro l e
* by p e rfo rm e d +a re by +i s fu l fi l e d
in +p a rti ci p a te 0 ..*
S tudyInv e s tiga tor 1
id: BRIDGID +
a cti vi ty +so u rce
as +p a rti ci p a te Role
has a
* Ac tiv ity
1 1 ..*
1 ..*
a cti vi ty +ta rg e t has a
Conc e ptRe la tions hip P a rtic ipa tion Role Role Re la tions hip
Cla s s -only dia gra m Compre he ns iv e cd
Participation::Study
Clinical Research Activ ities and
Implementation Independent Domain Analysis Model --BRIDG
cd Comprehensiv e Class and attribute diagram
What is a BAM?
• A UML model (primarily use case diagrams) that represents the
processes that occur in a domain of interest
• Uses domain terminology to represent processes that occur, shows the
decomposition of those processes, often in a logical sequence to help
both understanding of processes captured and facilitate identification of
missing elements
• Includes a brief description, a storyboard narrative, pre- and post-
conditions and actors who participate in the process
• Built using a iterative, top down approach to create a framework for the
domain of biomedical research facilitated by analysts who work with
subject matter experts to harmonize content provided by the community
• Allows the community to have a shared view of the processes that
comprise the domain of interest and to identify the context of particular
activities
Biomedical Research Business
Analysis Model (BAM)
Conduct Study > Manage Subjects > Manage Subject Study Registration
Obtain Initial
Review Informed
Subject's Consent
Medical Record Subj ect
«include» Intermediary
«include» Obtain Consent Authorized
for an Representativ e
Amendment to
the Informed
Obtain Informed «include»
Consent
Consent
Identify Subject
Study Subj ect
Enrolling Physician
Gather
Subject's
«include» Registration
«include»
Information Clinical Research
«include»
Associate (CRA)
«include»
Collect
Manage Manage Subject Demography
«include»
Conduct Study Study Data
«include» Subjects «include»
Registration
Collect
Registration
Data
«include» «include»
«include»
Legend
Released
Request Ensure
CTMS Workspace Reviewed Subject Awareness of Screen for
In CTMS Workspace Review Registration Funding Sources Eligibility
Draft / CTMS Working Group «include»
Placeholder Collect
Eligibility Data
Site Registrar /
Registration Requestor
Financial Representativ e
6
How is a DAM related to BAM?
• A DAM represents the data (static semantics) involved in the processes
represented in the BAM
• When a use case in a BAM is drilled down into an activity diagram, it may
include references to data exchanged, updated, etc. during the process –
the data should be static semantics represented in the DAM
• Both represent shared semantics
• Both are developed in a collaborative, consensus-building process
Gather
Subject's
Conduct Study > Manage Subjects > Manage Subject Study Registration
Use Case Model «include»
«include» Registration Review
Subject's
Medical Record
Obtain Initial
Informed
Consent
Subj ect
Information
(BAM) Clinical Research
«include» Intermediary
«include» Obtain Consent
«include»
Authorized
for an Representativ e
Amendment to
Obtain Informed
Consent
«include»
the Informed
Consent
Associate (CRA)
Identify Subject
«include» Enrolling Physician
Study Subj ect
«include»
Gather
Subject's
Registration
Collect
«include»
Information
Demography
Clinical Research
«include»
Associate (CRA)
Manage Manage Subject Manage «include» Manage Subject
«include»
«include»
Collect
Demography
Data
Conduct Study Study Data
«include» Subjects «include»
clude» Subjects «include»
Study Registration
Collect
Registration
Registration «include» «include»
«include»
Data
Legend
Released
Request Ensure
CTMS Workspace Reviewed Subject Awareness of Screen for
In CTMS Workspace Review Registration Funding Sources Eligibility
Draft / CTMS Working Group «include»
Placeholder Collect
Site Registrar /
Collect Eligibility Data
Registration Requestor
Registration Financial Representativ e
Data
«include» «include»
Storyboards in use case define the work flow and
«include»
Activity data flow that identify the pre- and post-conditions
Diagram CRA Investigator Registrar CRA Investigator Registrar Work Flow
Request Ensure
Subject Awareness of Screen for
Registration Funding Sources Eligibility Data Flow
«include»
Collect Actors
Registration Eligibility Data
Static
CRF
Site Registrar /
Registration Requestor
Elements
class C3PR Analysis Model class C3PR Analysis Model
class Lab Model
BRIDG-Based
BRIDG Release 1.0 -- Static BRIDG Release 1.0 -- Static
Classes::StudyInv estigator Classes::StudyInv estigator
Financial Representativ e
StudyDiseaseSite Documentation
+ role: CD
StudyDiseaseSite Documentation
+ role: CD
Name: Lab Model
BRIDG Release 1.0 -- Static Classes: BRIDG Release 1.0 -- Static Classes:: BRIDG Release 1.0 -- Static Classes: BRIDG Release 1.0 -- Static Classes::
:Organization
-
-
primaryDiseaseSiteIndicator: boolean
name: CD
StudyProtocol
+
+
startDate: dateTime
endDate: dateTime :Organization
-
-
primaryDiseaseSiteIndicator: boolean
name: CD
StudyProtocol
+
+
startDate: dateTime
endDate: dateTime
Author: ScenPro, Inc.
is conducted by / is conducted by /
+ organizationIdentifier: II + disease: CD
1
participates in
+
1..* +
status: CD
statusStartDate: dateTime
+ organizationIdentifier: II + disease: CD
1
participates in
+
1..* +
status: CD
statusStartDate: dateTime
Version: 1.0
+ name: string + phase: CD + name: string + phase: CD
+ description: string + intent: CD + statusEndDate: dateTime
StudyDisease
CalendarCell
+ description: string + intent: CD + statusEndDate: dateTime
StudyDisease
CalendarCell Created: 8/8/2006 2:03:19 PM
+ postalAddress: string + populationDescription: string + signatureText: string BRIDG Release 1.0 -- + postalAddress: string + populationDescription: string + signatureText: string BRIDG Release 1.0 -- Organization
+ telecomAddressType: string
BRIDG Release 1.0 -- Static
Classes::HealthCareSite
+ subjectType: CD
- primaryDiseaseIndicator: boolean
Static Classes:: + telecomAddressType: string
BRIDG Release 1.0 -- Static
Classes::HealthCareSite
+ subjectType: CD
- primaryDiseaseIndicator: boolean
Static Classes:: Updated: 5/3/2007 6:23:44 PM
+ telecomAddressUsage: string plays / is played + blindedIndicator: boolean PlannedCalendarCell + telecomAddressUsage: string plays / is played + blindedIndicator: boolean PlannedCalendarCell
1 - name: CD 1 - name: CD
+ blindingSchema: CD + blindingSchema: CD
+
+
telecomAddressValue: string by
status: CD
1 0..* + healthcareSiteIdentifier: II + multiInstitutionIndicator: boolean 1 1..* ::CalendarCell
+
+
telecomAddressValue: string by
status: CD
1 0..* + healthcareSiteIdentifier: II + multiInstitutionIndicator: boolean 1 1..* ::CalendarCell + id: Integer
+ postalAddress: string + note: string + postalAddress: string + note: string
+ randomizedIndicator: boolean + randomizedIndicator: boolean
+ statusStartDate: dateTime
+ confidentiality: CD
+ statusStartDate: dateTime
+ confidentiality: CD
+ identifier: String
+ statusEndDate: dateTime 1..* + statusEndDate: dateTime 1..*
defines a / for a defines a / for a
functions as / is
1 + monitor: CD
::Documentation 1 Calendar 1
1..* functions as / is
1 + monitor: CD
::Documentation 1 Calendar 1
1..* + name: String
1 1 represented by 1 BRIDG Release 1.0 -- Static Classes: 1 1 represented by 1 BRIDG Release 1.0 -- Static Classes:
+ identifier: II BRIDG Release 1.0 -- Static Classes:: + identifier: II BRIDG Release 1.0 -- Static Classes::
0..* 0..*
+ title: string :PlannedCalendar is the timing for / + title: string :PlannedCalendar is the timing for /
Class Diagrams
PlannedStudy PlannedStudy
+ detailedDescription: string occurs according + detailedDescription: string occurs according
BRIDG Release 1.0 -- Static + effectiveDateTime: dateTime BRIDG Release 1.0 -- Static + effectiveDateTime: dateTime
+ summaryDescription: string + targetAccrualNumber: int to BRIDG Release 1.0 -- Static Classes::Arm + summaryDescription: string + targetAccrualNumber: int to BRIDG Release 1.0 -- Static Classes::Arm
plays/ is played Classes::StudySite + referenceTimePoint: string plays/ is played Classes::StudySite + referenceTimePoint: string
+ synopsis: string + plannedSubjectParticipationDuration: string + synopsis: string + plannedSubjectParticipationDuration: string
by + plannedSubjectInterventionDuration: string 1 + armName: CD by + plannedSubjectInterventionDuration: string 1 + armName: CD
+ documentationType: CD + documentationType: CD
+
+
role: CD
accrualStatus: CD + subtype: SET CD ::StudyProtocol CalendarTS
::PlannedCalendarTS
+
+
role: CD
accrualStatus: CD + subtype: SET CD ::StudyProtocol CalendarTS
::PlannedCalendarTS Person
executes/ is + disease: CD 1 + plannedCalendarDateTime: dateTime executes/ is + disease: CD 1 + plannedCalendarDateTime: dateTime
+ targetAccrualNumber: int + revision: string + targetAccrualNumber: int + revision: string
executed at BRIDG Release 1.0 -- Static Classes:: executed at BRIDG Release 1.0 -- Static Classes::
+ irbApprovalDate: dateTime 0..* 1 + language: CD + phase: CD ::CalendarTS + irbApprovalDate: dateTime 0..* 1 + language: CD + phase: CD ::CalendarTS
0..*
+ startDate: dateTime + status: CD + intent: CD
PlannedCalendarTS
+ descriptiveName: string 0..*
+ startDate: dateTime + status: CD + intent: CD
PlannedCalendarTS
+ descriptiveName: string + id: Integer
+ endDate: dateTime + statusStartDate: dateTime + populationDescription: string + plannedCalendarDateTime: dateTime + timeOffset: int + endDate: dateTime + statusStartDate: dateTime + populationDescription: string + plannedCalendarDateTime: dateTime + timeOffset: int
plays/ is played BRIDG Release 1.0 --
+ status: CD
1
+ statusEndDate: dateTime + subjectType: CD + timeOffsetUnit: string plays/ is played BRIDG Release 1.0 --
+ status: CD
1
+ statusEndDate: dateTime + subjectType: CD + timeOffsetUnit: string + dateOfBirth: Date
by Static Classes:: 1 + blindedIndicator: boolean + rangeOfRepetitions: string by Static Classes:: 1 + blindedIndicator: boolean + rangeOfRepetitions: string
+ statusStartDate: dateTime + statusStartDate: dateTime
FundingSource
+ statusEndDate: dateTime + blindingSchema: CD
treated by/treats
+ timeOffsetReferencePoint: string FundingSource
+ statusEndDate: dateTime + blindingSchema: CD
treated by/treats
+ timeOffsetReferencePoint: string + initials: String
+ multiInstitutionIndicator: boolean + additionalDurationDescription: string + multiInstitutionIndicator: boolean + additionalDurationDescription: string
+ fundingIdentifier: II + fundingIdentifier: II
+ randomizedIndicator: boolean + randomizedIndicator: boolean
1 is sponsored by / 1 is sponsored by /
sponsors
BRIDG Release 1.0 -- Static Classes:: + confidentiality: CD
sponsors
BRIDG Release 1.0 -- Static Classes:: + confidentiality: CD 0..* 0..*
1 StudySubj ect + monitor: CD 1 StudySubj ect + monitor: CD
::Documentation BRIDG Release 1.0 -- ::Documentation BRIDG Release 1.0 --
CentralLaboratory PerformingLaboratory
BRIDG Release 1.0 -- + studySubjectIdentifier: II + identifier: II Static Classes::Epoch 1..*
1 BRIDG Release 1.0 -- + studySubjectIdentifier: II + identifier: II Static Classes::Epoch 1..*
1 +personCollection +personCollection
Static Classes:: + subgroup: CD + title: string Static Classes:: + subgroup: CD + title: string
0..* 0..*
operates as / StudySponsor is the treatment
is coordinated by / coordinates + informedConsentSignatureText: string + epochName: CD BRIDG Release 1.0 -- Static operates as / StudySponsor is the treatment
is coordinated by / coordinates + informedConsentSignatureText: string + epochName: CD BRIDG Release 1.0 -- Static
+ detailedDescription: string + detailedDescription: string
represented by location for / is + studySubjectState: string Classes::ArmSegment represented by location for / is + studySubjectState: string Classes::ArmSegment
0..* + summaryDescription: string 0..* + summaryDescription: string
+ sponsorType: CD assigned to + status: string 1 1..* + sponsorType: CD assigned to + status: string 1 1..*
+ statusStartDate: dateTime
+ synopsis: string
+ documentationType: CD
+ armSegmentName: CD + statusStartDate: dateTime
+ synopsis: string
+ documentationType: CD
+ armSegmentName: CD Study
1..*
+ statusEndDate: dateTime + subtype: SET CD
1..*
+ statusEndDate: dateTime + subtype: SET CD
Investigator Participant +centralLab 0..1 +performingLaboratory 0..1
+ revision: string 1..* + revision: string 1..*
0..* 0..*
1 + language: CD 0..* 0..*
1 + language: CD + id: Integer
+ status: CD NonTreatmentEpoch + status: CD NonTreatmentEpoch + identifier: String
+ identifier: String
The data elements that
CoordinatingCenter + statusStartDate: dateTime TreatmentEpoch CoordinatingCenter + statusStartDate: dateTime TreatmentEpoch
+ statusEndDate: dateTime
- accrualCieling: int
+ statusEndDate: dateTime
- accrualCieling: int + name: String
operates as / represented byStudyCoordinatingCenter - accrualIndicator: boolean 1
operates as / represented byStudyCoordinatingCenter - accrualIndicator: boolean 1 + name: String
StudySubj ect - enrollmentIndicator: boolean StudySubj ect - enrollmentIndicator: boolean
1 0..* 1 0..*
0..1
- reservationIndicator: boolean
0..1
- reservationIndicator: boolean + assigningAuthority: String
- informedConsentSignedDate: dateTime
1
- informedConsentSignedDate: dateTime
1
0..* +participant 1
participates as / has/is
1 1
participates as / has/is
1 1 +investigatorCollection
is fulfilled by
0..1
0..* for is fulfilled by
0..1
0..* for +study 1
BRIDG Release 1.0 -- Static 1 BRIDG Release 1.0 -- Static 1 +labTest 1 +labTestCollection 0..* +labResultCollection 0..*
Classes::Person Classes::Person
DiseaseHistory DiseaseHistory
+ name: string + name: string
+ initials: string - otherDiseaseName: CD + initials: string - otherDiseaseName: CD LabTest LabResult
+ postalAddress: string identifies events - otherDiseaseSite: CD + postalAddress: string identifies events - otherDiseaseSite: CD +specimenCollection +labTest
+ telecomAddressType: string for / has + telecomAddressType: string for / has
+ telecomAddressUsage: string 0..* + telecomAddressUsage: string 0..* Activity + id: Integer
+ telecomAddressValue: string
1 0..* + telecomAddressValue: string
1 0..* 0..* + id: Integer
+ birthDateTime: dateTime + birthDateTime: dateTime + status: String +labResult
+studySiteCollection +subjectAssignment 0..1 + numericResult: Integer
are exchanged in a data
StratificationFactor StratificationFactor
BRIDG Release 1.0 -- Static Classes:: BRIDG Release 1.0 -- Static Classes::
+ deathDateTime: dateTime
plays / is played Participant
EligibilityCriterion + deathDateTime: dateTime
plays / is played Participant
EligibilityCriterion
+studySiteCollection + id: Integer
+ educationLevel: CD - questionText: CD + educationLevel: CD - questionText: CD + additionalTestDescription: String
assigns/assigned + ethnicGroup: SET CD 1
by
0..* + participantIdentifier: II
-
-
notApplicableIndicator: boolean
questionText: CD
- displayOrder: int assigns/assigned + ethnicGroup: SET CD 1
by
0..* + participantIdentifier: II
-
-
notApplicableIndicator: boolean
questionText: CD
- displayOrder: int
0..* 0..* + identifier: String SpecimenCollection 1 0..1 + numericPrecision: Integer
by + gender: CD
+ confidentialityIndicator: boolean - displayOrder: int
by + gender: CD
+ confidentialityIndicator: boolean - displayOrder: int SubjectAssignment + comments: String + textResult: String
+ householdIncome: CD
+ paymentMethod: CD
+ householdIncome: CD
+ paymentMethod: CD +subjectAssignment +activityCollection + actualStartDateTime: Date
+ maritalStatus: CD + maritalStatus: CD + id: Integer + studyDefinedIndicator: Boolean + referenceRangeLow: Integer
+ race: SET CD
StratificationFactorValidAnsw er
+ race: SET CD
StratificationFactorValidAnsw er StudySite + actualEndDateTime: Date
+studySite + id: Integer + subjectAgeAtCollection: Integer + studyScheduledIndicator: Boolean + referenceRangeHigh: Integer
ExclusionEligibilityCriterion
- validAnswer: CD
ExclusionEligibilityCriterion
- validAnswer: CD 1 0..* + plannedTimeElapsed: String
CalendarCell CalendarCell
+ type: String + subjectAgeAtCollectionUnits: String + referenceRangeComments: String
+ id: Integer + plannedTimeElapsedDescription: String +labTestCollection 0..* +labTest 0..*
BRIDG Release 1.0 -- Static Calendar BRIDG Release 1.0 -- Static Calendar
+ studySubjectIdentifier: String + fastingStatus: String + referenceTextList: String
Classes:: BRIDG Release 1.0 -- Classes:: BRIDG Release 1.0 -- 1 0..* + reason: String
ScheduledCalendarCell Static Classes:: 1 ScheduledCalendarCell Static Classes:: 1 + method: String + reportedResultStatus: String
ScheduledCalendar is used to create ScheduledCalendar is used to create
+studySiteCollection 0..* + plannedIndicator: Boolean
::CalendarCell 1..* 1
0..*
a / is a subject- ::CalendarCell 1..* 1
0..*
a / is a subject- +subjectAssignmentCollection + testPerformedDateTime: Date
+ note: string specific
description of
InclusionEligibilityCriterion
+ note: string specific
description of
InclusionEligibilityCriterion + typeModifier: String +specimenCollection 1..1
gender race + referenceFlag: String
flow are represented as
is the timing for / 1..* is the timing for / 1..*
occurs according 1 occurs according 1
to
CalendarTS
to
CalendarTS
+labResultCollection 0..*
BRIDG Release 1.0 -- Static Classes:: BRIDG Release 1.0 -- Static Classes::
ScheduledCalendarTS ScheduledEpoch ScheduledCalendarTS ScheduledEpoch
+healthCareSite 1 +specimenCollection 1..* +specimen 1
+ scheduledCalendarDateTime: dateTime + scheduledCalendarDateTime: dateTime
::CalendarTS ::CalendarTS
+ descriptiveName: string + descriptiveName: string
+ timeOffset: int + timeOffset: int HealthCareSite +gender 1 +race 1 Specimen
+ timeOffsetUnit: string + timeOffsetUnit: string
+ rangeOfRepetitions: string + rangeOfRepetitions: string
+ timeOffsetReferencePoint: string + timeOffsetReferencePoint: string + id: Integer labTestId
+ additionalDurationDescription: string ScheduledNonTreatmentEpoch + additionalDurationDescription: string ScheduledNonTreatmentEpoch ConceptDescriptorDataType
+ identifier: String
units
+ id: Integer + accessionNumber: String
class diagrams
EligibilityCriterionAnsw er EligibilityCriterionAnsw er
+ code: String +materialType +specimenCollection + condition: String
ScheduledTreatmentEpoch ScheduledTreatmentEpoch
ScheduledArmSegment - answer: string ScheduledArmSegment - answer: string
BRIDG/RIM Entity + codeSystem: String + commentsFromLaboratory: String
- armSegmentName: string - armSegmentName: string 1 materialType 0..*
+ codeSystemName: String + commentsFromInvestigator: String
BRIDG/ RIM Role + codeSystemVersion: String
+labTestId
+ displayName: String
identified identified
Identifier Identifier
by/identifies identified by/identifies identified BRIDG/ RIM Participation 1
- value: string by/identifies - value: string by/identifies
- type: string identified - type: string identified
by/identifies by/identifies +units
0..* 0..*
BRIDG/ RIM
OrganizationAssignedIdentifier SystemAssignedIdentifier StratificationFactorAnsw er OrganizationAssignedIdentifier SystemAssignedIdentifier StratificationFactorAnsw er
Activity/Act 1
- answer: string - answer: string
CDE Id’s
The activities in activity
diagrams could inform
the work flow and
functions of the
C3PR PSC applications Lab Viewer 8
