RPSR3ProjectPlanv1-0

8/10/2019 RPSR3ProjectPlanv1-0

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Document Version Control

Version Date Author Change Description

0.1 4.Feb.2010 Geoff Williams Initial version

0.2 8.Feb.2010 Geoff Williams Comments from Joe Cipollina, MartiVelezis

0. 1.Mar.2010 Geoff Williams Comments from !ir!"lation to #$% #

Wor&in' Gro"p (Mar& Gra), *a&"Watanabe+

0.4 1.Mar.2010 Geoff Williams Comments from #$% # $ro-e!t

ea/ersip *eam

0. 0.Mar.2010 Geoff Williams Comments from #$% # Wor&in' Gro"p

1.0 1.Mar.2010 Geoff Williams Minor !an'es an/ release

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Table of Contents

1. $#J3C* V3#VI3W..............................................................................................

1.1 o!"ment r'anization.............................................................................

2. 5J3C*IV3%, %C$3, %6CC3%% C#I*3#I7........................................................

2.1 $ro-e!t b-e!tives......................................................................................

2.1.1 #e'ionalomain b-e!tives.....................................................................

2.2 $ro-e!t %!ope.............................................................................................

2.2.1 In %!ope.....................................................................................................

2.2.2 "t of %!ope..............................................................................................

2. Completion an/ %"!!ess Criteria...............................................................

. $#J3C* $79%C:363.................................................................................

4. $#J3C* 3IV3#753%....................................................................................

. 3$3939CI3%, C9%*#7I9*% 79 7%%6M$*I9%..................................

.1 epen/en!ies...........................................................................................

.1.1 Wor& on #$% #2.....................................................................................

.1.2 Common $ro/"!t Mo/el.........................................................................

.1. 5#IG :armonization............................................................................

.2 Constraints...............................................................................................

.2.1 eliver) of #e'ional or omain #e;"irements......................................

.2.2 I% 5allot $ro!ess...................................................................................

. 7ss"mptions..............................................................................................1 %*6 Version of #$% #2 7vailable.......................................................


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8. $#J3C* C9*#% 79 CMM69IC7*I9%.............................................

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GLOSSARY OF TERMS

Acronym Term

7/vaMe/ 7/van!e/ Me/i!al *e!nolo') 7sso!iation

5#IG 5iome/i!al #esear! Inte'rate/ omain Gro"pC39 Comit@ 3"rop@en /e 9ormalisation (3"ropean Committee for

%tan/ar/isation+

CM3* Common Messa'e 3lement *)pe

C$M Common $ro/"!t Mo/elC*7 Clini!al *rial 7ppli!ation

%*6 raft %tan/ar/ for *rial 6se

eC* ele!troni! Common *e!ni!al o!"ment3F$I7 3"ropean Fe/eration of $arma!e"ti!al In/"stries an/ 7sso!iations

36 3"ropean 6nion

F7 Foo/ an/ r"' 7/ministration

: :ealt evel :M :ierar!i!al Messa'e efinition

IC: International Conferen!e on :armonisation of *e!ni!al #e;"irements for#e'istration of $arma!e"ti!als for :"man 6se

I% International r'anization for %tan/ar/ization

I*% Implementable *e!nolo') %pe!ifi!ation

JIC Joint Initiative Co"n!ilM77 Mar&etin' 7"torisation 7ppli!ation

97 9eA r"' 7ppli!ation

9MV 9e?t Ma-or Version$6F7 $res!ription r"' 6ser Fee 7!t

$#M7 $arma!e"ti!al #esear! an/ Man"fa!t"rers of 7meri!a$M7 $arma!e"ti!als an/ Me/i!al evi!es 7'en!)#BMIM #efine/ Messa'e Information Mo/el

#$% #e'"late/ $ro/"!t %"bmission

#C#IM #e'"late/ Clini!al #esear! Information Mana'ement

%*3 %"mmar) *e!ni!al o!"ment

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1. RO!ECTOVERV"E#

*e : V #e'"late/ $ro/"!t %"bmission (#$%+ stan/ar/, #elease 1 (#1+ be!ame a

9ormative %tan/ar/ in 200

b-e!tives, %!ope an/ %"!!ess Criteria

$ro-e!t $lan%!e/"le

epen/en!ies, Constraints an/ 7ss"mptions

$ro-e!t #is&s

$ro-e!t r'anization an/ Governan!e $ro-e!t Controls an/ Comm"ni!ations

&. O'!ECT"VES( SCOE( S)CCESSCR"TER"A

*e overall ob-e!tives an/ s!ope b"il/ on te previo"s #$% #1 an/ #2 Aor&.

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&.1 ro*ect Ob*ecti+es

*e ob-e!tives for te #$% # pro-e!t are>

eliver) of te #$% # 9ormative %tan/ar/ meetin' te re;"irements of te

parti!ipatin' sta&eol/ers

7n : implementation '"i/e for te stan/ar/

7li'ne/ vo!ab"laries for te implementation of te stan/ar/ b) te vario"s

sta&eol/ers

7 ballot an/ a!!eptan!e of te #$% # omain 7nal)sis Mo/el

7 plan for movin' te : stan/ar/ to an I% stan/ar/.

&.1.1 Re$ional,Domain Ob*ecti+es

It so"l/ be note/ tat te re'ional an/ /omain elements of te #$% # stan/ar/ ma) be

;"ite i', so in/ivi/"al re'ions/omains ave also in/entifie/ a//itional ob-e!tives to

ens"re tat te) !an implement te stan/ar/. *e pro-e!t Aill tra!& tese ob-e!tives an/

see& to ens"re tat all intereste/ parties !an implement te stan/ar/ Aito"t te nee/ fora//itional Aor& on te spe!ifi!ation.

FDA> *e f"ll /efinition an/ in!l"sion of te international re;"irements bro"'t forAar/

b) te IC: as part of te /evelopment of te eC* 9e?t Ma-or Version for s"bmissions

in te "man parma!e"ti!als area an/ te in!l"sion of me/i!al /evi!e re;"irements.

F7 e?pe!ts to "se te #$% # messa'e, in!orporatin' F7 re'ional re;"irements an/

te res"lts of te #$% #2 %*6 testin', in investi'ational an/ mar&etin'

appli!ationss"bmissions. Meetin' tis ob-e!tive Aill enable F7 to move forAar/, in

!ollaboration Ait o"r international partners, Ait te implementation an/ a!!eptan!e of

#$% base/ s"bmissions.

EFPIA/EU> *e #$% # spe!ifi!ation m"st s"pport te !"rrent s!ope of teimplementation of te IC: eC* in 3"rope for M77s an/ relate/ s"bmission t)pes for

all re'"lator) revieA pro!e/"res. In a//ition, te # release so"l/ intro/"!e te

f"n!tionalit) i/entifie/ in te IC: re;"irements for te eC* 9e?t Ma-or Version an/

a//itional 36 spe!ifi! re;"irements i/entifie/ to te pro-e!t team (to in!l"/e, b"t not

limite/ to, te i/entifi!ation of re'"lator) approval stat"s+.*is ma) also in!l"/e te

s"pport for a//itional s"bmission t)pes (e.'., te 3"ropean Clini!al *rial 7ppli!ation+,

to"' te initial implementation pase mi't not in!l"/e te f"ll /efinition of tese

s"bmission t)pes.

3F$I7 is also &een to see te # stan/ar/ /evelope/ to s"pport te !"rrent s!ope of

eC* implementation in %Aitzerlan/.

PMDA> eliver) of #$% # te!ni!al spe!ifi!ation tat is (partiall) or Aoll)+

implementable in Japan as an IC: eC* messa'e spe!ifi!ation for 97.

HealthCanaa> :ealt Cana/a inten/s to "se #$% # to s"pport re'"lator) s"bmission

a!ross te /ifferent pro/"!t lines re'"late/ b) te a'en!). *is Ao"l/ in!l"/e te

pro/"!ts in!l"/e/ Aitin te s!ope of IC:, "man parma!e"ti!al an/ biolo'i!s, b"t also

me/i!al /evi!es an/ /r"'s for veterinar) "se.

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A!aMe> efine 'lobal re;"irements for #$% tat Aill alloA te me/i!al /evi!e

in/"str) to implement an ele!troni! version of te %*3.

&.& ro*ect Sco-e

*e pro-e!t s!ope is mainl) /efine/ in terms of te f"n!tionalit) re;"irements to be

/evelope/ to s"pport te "se b) te sta&eol/er 'ro"ps.&.&.1 "n Sco-e

*e folloAin' areas ave been i/entifie/ for /evelopment in #$% # Aitin te stan/ar/>

1. *AoBAa) !omm"ni!ations (in!l"/in' intera'en!) (m"ltiBre'"lator+ !omm"ni!ations,

an/ e?pansion of !"rrent tAoBAa) !omm"ni!ation a!tivities+ D *is in!l"/es

Etrea/e/ /is!"ssions, /ivi/in' an/ tra!&in' re'"lator information re;"ests an/ te

responses into in/ivi/"al items.

2. #eferen!in' (e.'., appli!ation to appli!ation, s"bmission to s"bmission, et!.+ D *is

Aill in!l"/e re;"irements for referen!in' appli!ationss"bmissions not EoAne/ b)

te s"bmitter (e.'., Master Files+.

. ife!)!le mana'ement, in!l"/in' te !omple? relationsips of /o!"ments in 3"ropeanre'"lator) pro!esses (mana'ement of te M"t"al #e!o'nition $ro!e/"re an/ te neA

Variation re'"lation tat alloAs sin'le s"bmission "nits to be s"bmitte/ tat !ontain

!an'es for m"ltiple pro/"!ts+ an/ oter re;"irements bro"'t forAar/ b)

sta&eol/ers.

4. 7//itional information abo"t te s"bmission (e.'., pro/"!t, sen/erre!ipient,

/o!"mentelementleaf meta/ata+, b"il/in' on te #2 set b) aimin' to a!ieve an

ali'ne/ information set tat !an be "se/ on an international basis. *is Aill in!l"/e a

revieA of te Common $ro/"!t Mo/el (C$M+ elements tat mi't be "se/ in an #$%

messa'e.

a+ 7 f"ll) /evelope/ version of te Common $ro/"!t Mo/el an/ asso!iate/

Common Messa'e 3lement *)pes (CM3*s+, an/ spe!ifi!all)#$ro/"!t#eportable, Aere "se/ to meet te #$% #2 pro/"!t re;"irements.

F"rter /evelopment Aor& is envisa'e/ to /etermine te /efa"lt an/ re'ional

C$M re;"irements tat Aill be nee/e/ in te #$% # stan/ar/.

. :)perlin&in' iss"es tat ave been i/entifie/. *is in!l"/es te iss"e tat as arisen

from eC* e?perien!e &noAn as te E5ro&en in& iss"e, b"t is reall) asso!iate/

Ait te fa!t tat a!tive lin&s betAeen /o!"ments e?ist even after te tar'et /o!"ment

as been remove/ or repla!e/. It is a!&noAle/'e/ tat tis iss"e ma) not be resolve/

b) a p"rel) te!ni!al sol"tion Aitin te #$% messa'e b"t be an artefa!t of te "se of

$F files Aitin te messa'e. :oAever, te intent is to provi/e a better resol"tion to

tis iss"e tro"' te!ni!al an/or pro!ess means tat !an be implemente/ on a

'lobal basis. ter lin&in' or information relation re;"irements ma) also be

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a+ *e IC: re;"irements (v1.0+ Aere forAar/e/ to te #$% pro-e!t in late 200 for

an initial revieA. F"ll /eliver) of tese re;"irements, pl"s an) oters tat arise

/"rin' te # pro-e!t re;"irements /evelopment, Aill !ome from tis pro-e!t

"nless oterAise a'ree/ b) te IC: representatives.

. #e'ional re;"irements tat are nee/e/ to s"pport te 'lobal a/option of te stan/ar/

b) in/"str) /omains, parti!"larl) relatin' to te eC* 9MV.a+ For e?ample, te 36 Aants to in!l"/e information abo"t te stat"s of a re'"lator)

a!tivit) in te messa'e to s"pport te life!)!le vieAin' of te pro/"!t s"bmission.

*e) also ave re;"irements tat Aill elp s"pport te m"lti pro/"!t s"bmission

t)pes nee/e/ to s"pport te lo!al variation re'"lation.

b+ It is e?pe!te/ tat oter IC: re'ions an/ observers Aill brin' re'ional

re;"irements to te #$% # pro-e!t. *is seems li&el) base/ on te Aa)s in

Ai! tese re'ions ave implemente/ te e?istin' IC: eC* spe!ifi!ation to

meet teir re'ional re;"irements.

8. *e "p/ate to te Implementable *e!nolo') %pe!ifi!ation (i.e., mi'ration from I*% 1

to I*% 2+

. It is e?pe!te/ tat te implementation of te #$% #2 %*6 stan/ar/ ma) i/entif)f"rter !an'es to te basi! #$% information mo/el tat so"l/ be in!l"/e/ in te

#$% # release.

*Ao items to be /elivere/ as part of te s!ope are>

1. *e #$% # omain 7nal)sis Mo/el Aill also be ballote/ as an Informative ballot

pa!&a'e an/ Aill be in armonization Ait te 5#IG v.? mo/el. *is is part of te

on'oin' effort a!ross all #C#IM sponsore/ stan/ar/s to ens"re tat te) are

!ompliant Ait te 5#IG omain 7nal)sis Mo/el.

2. 7 plan for te f"rter pro'ression from te : #$% # 9ormative %tan/ar/ to an

I% (an/ C39+ stan/ar/. *e IC: /evelopment Aor& is /epen/ent on te finalstan/ar/ for teir implementation p"rposes to be an I% an/ C39 stan/ar/. ter

sta&eol/ers rel) on te I% to formall) a/opt an/ implement stan/ar/s an/ ma) also

benefit from te pro'ression from : to I% stan/ar/, to"' it is also re!o'nise/

tat te) ma) Aor& Ait oter te!ni!al !ommittees Aitin I%.

&.&.& Out of Sco-e

*e folloAin' items are !onsi/ere/ to be o"t of s!ope>

1. #e'ional or /omain implementation '"i/es an/ pro!esses. For e?ample, te IC:

eC* 9MV Aor& Aill /evelop an implementation '"i/e an/ te re'ions an/ observer

!o"ntries Aill also nee/ to /evelop lo!al implementation pro!esses an/ '"i/an!e/o!"ments. o!al implementation ma) also in!l"/e an) lo!al vo!ab"lar) lists nee/e/

to s"pport te lo!al implementation.

&. Com-letion an/ Success Criteria

*e s"!!ess of tis pro-e!t Aill be meas"re/ b) te !ompletion of a stan/ar/ tat refle!ts

te !ommon international an/ re'ional re;"irements o"tline/ in te s!ope of tis pro-e!t.

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. RO!ECTLA0,SCED)LE

Timeline/Date

"ange

Project #tage/ Milestone Comments

Project #etup

JanBMar 2010 $ro-e!t %et"p

"e$uirements %athering an De!elopment

Mar! 2010 D

J"ne 2010

%tart of stan/ar/s /evelopment

pro!ess

*e pro-e!t Aill be'in Ait te

in!orporation of IC:

re;"irements an/ /is!"ssion, as

nee/e/, to "n/erstan/ an/ f"ll)

/o!"ment tese re;"irements.

Mar! 2010 D

J"l) 2010

Colle!tion of te re'ional

/omain re;"irements

3a! re'ion/omain Aill be

responsible for !olle!tin' teiroAn re;"irements.

*o en/ of

!tober 2010

Inte'ration of re'ional/omain

re;"irements into pro-e!t

re;"irements set

#e'ional/omain re;"irements

Aill be /is!"sse/ an/ inte'rate/

into te f"ll set of pro-e!t

re;"irements. %ome re'ional

re;"irements !o"l/ be a/opte/ as

!onsens"s re;"irements for te

entire pro-e!t, Aile oters Aill

remain re'ional in nat"re.

3n/ of!tober, 2010

7ll re;"irements sall bes"bmitte/ to te /evelopment

team

#peci&ication Design

9ovember,

2010

Creation of /raft spe!ifi!ation

/o!"ments

e!ember,

2010B Jan"ar)

2011

#evieA of /o!"mentation b)

team

In te #2 pro-e!t tis pase Aas

not "n/erta&en an/ it Aas

observe/ tat tere Aere more

iss"es raise/ /"rin' te %*6ballot perio/ as a res"lt.

Febr"ar) 2011 6p/ate an/ finalisation of final

spe!ifi!ation /o!"ments

D#TU 'allot

Feb 2011 $reparation of %*6 5allot Form sall be s"bmitte/ via te

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Timeline/Date

"ange

Project #tage/ Milestone Comments

Materials an/ 9otifi!ation of

Intent to 5allot

#C#IM Wor&in' Gro"p.

Content to be ballote/ in!l"/e>

#$% # %*6 an/ omain7nal)sis Mo/el Informative

5allot

ea/line is Febr"ar), 2011

Initial Content ea/line ea/line is Febr"ar), 2011

Final Content ea/line ea/line is Mar!, 2011

7pr 2011 B

Ma) 2011

%*6 5allot #evieA an/

#e!on!iliation

5allot #evieA Aill be el/

betAeen 9ovember 2, 2010 D

Jan"ar) , 2011.5allot #e!on!iliation Aill be'in

te Aee& of Jan"ar) 10, 2011

"ntil all !omments are a//resse/.

D#TU Testing

Febr"ar) 2011

D Jan"ar)

2012

%*6 *estin' %"bmit %*6 7pproval re;"est>

http://www.hl7.org/library/committee

s/tsc/DS!"#$blicatio%"&e'$est"

emplate.(oc

$reparation of 9ormative%tan/ar/ 5allot Materials an/

9otifi!ation of Intent to 5allot

(ormati!e #tanar 'allot

Ma) 2012 9ormative 5allot

$ro-e!t Completion

2. RO!ECTDEL"VERA'LES$ro-e!t /eliverables ave been /efine/ for ea! pase of te pro-e!t, as /es!ribe/ in te

$ro-e!t $lan%!e/"le se!tion above. *ese Aill in!l"/e, b"t are not ne!essaril) limite/

to, te folloAin'>

Phase Deli!era)le*s+

$ro-e!t %et"p $ro-e!t %!ope %tatement

$ro-e!t $lan

11
http://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.dochttp://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.dochttp://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.dochttp://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.dochttp://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.dochttp://www.hl7.org/library/committees/tsc/DSTU_Publication_Request_Template.doc


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#is& lo'

#e;"irements Gaterin' an/

evelopment

6se Case 7nal)sis

%tor) boar/sGlossar)

Information Mo/el (Con!ept"al+5"siness *ri''er 7nal)sis$ro!ess FloAs

ptions for I% pro!ess

#e'ional/omain stor)boar/s an/ /o!"mentation

%pe!ifi!ation esi'n Information Mo/el (esi'n+

#IM :armonization #e;"ests%tate transitions

7ppli!ation #oles

%)stem Intera!tions

%*6 5allot %*6 stan/ar/omain 7nal)sis Mo/el for ballot

#BMIM an/ /erive/ :M an/ s!ema

5allot re!on!iliation /o!"mentation

%*6 *estin' *estin' plan

*estin' s!ripts*est res"lts

*est report

9ormative %tan/ar/ ballot 9ormative %tan/ar/

$ro-e!t !ompletion $ro-e!t !ompletion report

In a//ition, all 'ro"p an/ s"bB'ro"p meetin's so"l/ pro/"!e meetin' a'en/as an/

min"tes.

*e : Wi&i for te #$% # Aill be "se/ to mana'e te /o!"ment /eliverables

i/entifie/.

3. DEE0DE0C"ES( CO0STRA"0TSA0DASS)MT"O0S

*is se!tion provi/es te &noAn /epen/en!ies, !onstraints an/ ass"mptions at te start of

te pro-e!t, all s"bse;"ent a//itions sall be mana'e/ Aitin pro-e!t artefa!ts (e.'., ris&

matri?, pro-e!t s!e/"le, et!.+

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3.1 De-en/encies

*e folloAin' se!tion spe!ifies !omplete/, on'oin' or f"t"re pro-e!ts or te lin&a'es to

establise/ pro'rams, on Ai! tis pro-e!t /epen/s in or/er to be s"!!essf"l, or Ai!

are /epen/ent on tis pro-e!t.

3.1.1 #or4 on RS R$% #2 Aas ballote/ for %*6 in Jan"ar) 2010. 7 perio/ of %*6 testin' Aill ta&e

pla!e in 2010 an/ is tar'ete/ (base/ on te !"rrent #C#IM pro-e!t roa/map+ to be

ballote/ as a 9ormative stan/ar/ in Jan"ar) 2011.

#$% # as been a!!epte/ as a pro-e!t for /evelopment in Jan"ar) 2010. *e

/evelopment of te #$% # stan/ar/ Aill "se te #$% #2 %*6 stan/ar/ as te baseline

from Ai! f"rter Aor& Aill start.

Clearl), fin/in's from te #$% #2 %*6 testin' so"l/ be fe/ into te /evelopment of

te #$% # stan/ar/. *e !"rrent plannin' for te %*6 testin' is to test in a b"siness

settin' a n"mber of te f"n!tionalities in!orporate/ into te #1 an/ #2 stan/ar/s tat

ave not been "se/ in /etail. It is ver) li&el) tat tis t)pe of testin' Aill "n!over!an'esimprovements to te #$% #2 #BMIM an/or refinements in an) of te stan/ar/Hs

artefa!ts. 7 me!anism for !omm"ni!ation betAeen te #$% # team an/ te #2 %*6

testin' team(s+ m"st be i/entifie/.

7t te time of Aritin', te /evelopment pat for #$% #2 after te %*6 perio/ is

!omplete/ is not !lear. *e main /e!ision to be ma/e is Aeter te #2 stan/ar/ sall

pro'ress to a 9ormative %tan/ar/ or Aeter all f"rter /evelopment Aill transition to te

#$% # %*6. $ro'ression to a 9ormative %tan/ar/ e?ten/s te perio/ Aere

/epen/en!e betAeen te tAo stan/ar/s Aill be an iss"e an/ 'reatl) in!reases te

ali'nment b"r/en betAeen te tAo pro-e!ts. :oAever, tere ma) be a b"siness !ase to be

ma/e for te #2 stan/ar/ to be pro'resse/ to a 9ormative %tan/ar/.

7 tas& to !larif) tis position Aill be i/entifie/ for te # pro-e!t Aor&. It is possible tat

a /e!ision !o"l/ be ta&en as late as %eptemberB!tober 2010, Aen assembl) of te

information pa!&a'e to s"pport te # %*6 pase be'ins. It is a!&noAle/'e/ tat a

;"i!&er /e!ision Ao"l/ re/"!e te overall amo"nt of Aor& to be "n/erta&en on ali'nment

betAeen te tAo stan/ar/s.

3.1.& Common ro/uct Mo/el

*e #$% #2 %*6 stan/ar/ as a basi! pla!e ol/er to lin& to te Common $ro/"!t

Mo/el CM3*. F"rter /evelopment of te C$M stan/ar/ so"l/ alloA better /efinition

of te !ontent to be in!l"/e/ in te #$% # stan/ar/.

*e #$% #2 re;"irements in!l"/e a limite/ set of pro/"!t attrib"tes an/ /"rin' te #$%

#2 ballot re!on!iliation tere Aas /is!"ssion on te nee/ for a #$% Common $ro/"!t

CM3*. #C#IM a'ree/ to move forAar/ Ait te CM3* an/ to ma&e a /e!ision /"rin'

te #$% # pro-e!t on te !ontin"e/ "se of te CM3* or to in!l"/e te spe!ifi! pro/"!t

attrib"tes in te #$% mo/el. *is /e!ision Aill be base/ on te n"mber of pro/"!t

attrib"tes tat Aill be in!l"/e/ in te #$% messa'e.

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3.1. 'R"DG armoni%ation

*e #$% # omain 7nal)sis Mo/el Aill be /evelope/ from te e?istin' #$% #2

omain 7nal)sis Mo/el (Ai! overlaps Ait te 5#IG release base mo/el+. *e

armonisation a!tivities Aill be !oor/inate/ Ait te 5#IG %emanti! Coor/ination

Committee (%CC+ an/ prioritize/ in teir s!e/"le base/ on te priorities of te &e)

sta&eol/ers (9CI, F7, CI%C an/ :+ via te 5#IG 5oar/ of ire!tors.

*e ballotin' of #$% # !ontent Aill be in!orporate/ into te 5#IG a!!or/in' to te

5#IG pro-e!t s!e/"le.

3.& Constraints

*is se!tion spe!ifies an) limitations Ai! are o"tsi/e te !ontrol of te pro-e!t an/

aro"n/ Ai! te pro-e!t m"st be mana'e/.

3.&.1 Deli+er5 of Re$ional or Domain Re6uirements

%"!!essf"l implementation of te #$% stan/ar/ Aill onl) be possible if te re'ional

an/or /omain re;"irements for te stan/ar/ ave been f"ll) i/entifie/ an/ bro"'t into

te /evelopment pro!ess. *is inp"t is /epen/ent on te parti!ipation of in/ivi/"als from

tese sta&eol/er 'ro"ps Ao are empoAere/ to i/entif) an/ a'ree tese re;"irements.

*e #$% # pro-e!t Aill Aor& to i/entif) te in/ivi/"als representin' te

re'ional/omain e?perts an/ see& to brin' tem into te pro-e!t at an earl) sta'e. *e)

so"l/ be briefe/ abo"t te timelines for te pro-e!t an/ "n/erstan/ te impa!ts. Fail"re

to /eliver te inp"ts !o"l/ !reate /ela)s in te pro-e!t timeline, fail"re to /eliver a

stan/ar/ tat meets teir re;"irements as e?pe!te/, an/or removal of teir re;"irements

from te s!ope of te pro-e!t.

3.&.& "SO 'allot rocess

C"rrentl) tere is a &noAn iss"e Ait oA to ta&e te #$% # !ontent into te I%!omm"nit) for ballot. 7t tis point in time, te e?a!t pro!ess tat Aill be e?e!"te/ is

"n/etermine/.

ptions ma) be in pla!e to "se te e?istin' : to I% Fast *ra!& pro!ess.

7lternativel), a f"ll pro!ess to ta&e te stan/ar/ to I% mi't be emplo)e/. It is also

possible tat te JIC ma) be "se/ to pro'ress te stan/ar/ tro"' to an I% stan/ar/.

*e #$% # pro-e!t Aill i/entif) an/ !onta!t te &e) in/ivi/"als Aitin : an/ I% to

/etermine te options available. *e sta&eol/ers, tro"' te $ro-e!t ea/ersip *eam

Aill ten /e!i/e on te most appropriate ro"te to re!ommen/ for te : #$% 9ormative

%tan/ar/ to be!ome an/ I% stan/ar/.

3. Assum-tions

*e folloAin' se!tion spe!ifies an) !ir!"mstan!es or events Ai! m"st be tr"e or m"st

o!!"r for te pro-e!t to be s"!!essf"l.

3..1 DST) Version of RS R& A+ailable

*ere is an ass"mption tat te #$% #2 %*6 !ontent Aill be "se/ to e?ten/ te e?istin'

s!ope of te pro-e!t. *e pro-e!t Aill !ommen!e before te resol"tion of #$% #2 ballot

14


15/21

!omments. 7t s"! time tat te re;"irements are rea/) for in!orporation into te #$%

#2 #efine/ Messa'e Information Mo/el (#BMIM+, te mo/el sall refle!t all !an'es

ne!essar) to resolve #$% #2 ballot !omments so tat tere Aill not be an) !omments

!arrie/ into te #$% # #BMIM.

7. RO!ECTR"S8S

9o spe!ifi! ris&s to te pro-e!t Aere i/entifie/ /"rin' te %et"p pase. 7ll f"t"re ris&s

Aill be /o!"mente/ an/ mana'e/ in te pro-e!t ris& lo'. 7n e?ample lo' is soAn beloA,

alon' Ait te meto/ for /eterminin' te overall ris& ratin'. 7ll :i' level ris&s m"st

ave a miti'ation strate') /evelope/ an/ an oAner assi'ne/ an/ be monitore/ on an

on'oin' basis b) te $ro-e!t ea/ersip team. 7ppropriate a!tions so"l/ be ta&en an/

on'oin' strate') /e!isions "p/ate/ as te sit"ation is monitore/. 7ll !an'es m"st be

"p/ate/ on te #is& o' an/ final a!tions so"l/ be !lose/ before te pro-e!t is

!omplete/.

7ll Me/i"m level ris&s so"l/ also ave a miti'ation strate') /evelope/ an/ an oAnerassi'ne/, oAever, revieA ma) ta&e pla!e on a less fre;"ent basis. 7!tions so"l/ be

monitore/ an/ "p/ate/ an/ !lose/ before te en/ of te pro-e!t. #is&s rate/ oA level

/o not ne!essaril) nee/ a miti'ation strate') to be /evelope/. 7 re'"lar revieA nee/ not

be !arrie/ o"t b"t a final assessment m"st be ma/e before te pro-e!t !an be !lose/.

ID "is, Description Pro)a)ility

*A+

Impact

*'+

"ating

*A - '+

Mitigation .ner

robabilit5 9A:;0 *+ery $%li,ely- 5- 1 *$%li,ely- betwee% 5 a%( 20- 2 *li,ely- 2060- 3 *+ery li,ely-60

"m-act 9':;0 *%o epecte( impact- 1 *mi%or: b$(get o+err$% 10 a%( sche($le o+err$% 10 - 2*me(i$m- 3 *maor- b$(get o+err$% 30 a%(/or sche($le 30

Ris4 ratin$ 9A < ':;e+el o serio$s%ess. 0 2 ow- 3 5 e(i$m- 6 9 igh

15


16/21

=. RO!ECTORGA0"SAT"O0A0DGOVER0A0CE

=.1 Or$anisation

=.& Go+ernance

*e #$% $ro-e!t is sponsore/ Aitin : b) te #C#IM Wor&in' Gro"p. #C#IM as a

e!ision Ma&in' $ra!ti!e tat is /o!"mente/ at> Insert 6# an/ sall be a/ere/

to Aen it !omes to ma&in' /e!isions on te pro-e!t team, "nless te sit"ation is not

a//resse/ Aitin te /o!"ment or Aen te pro-e!t mana'ement /etermines te iss"e

so"l/ be a//resse/ "n/er te folloAin' '"i/elines>

9eA %!ope sall 'o tro"' a formal /e!ision ma&in' pro!ess, an/ re;"ire a neA

pro-e!t proposal approval

$rioritization of s!ope items, in te !ase Aere te entire # s!ope !annot be

a//resse/ in te time allo!ate/, te pro-e!t lea/ersip Aill Aor& Ait te pro-e!t

team to /etermine Aeter to !an'e te timeline or re/"!e te s!ope for te

%*6 ballot

7n) oter reasons to e?e!"te a /e!ision ma&in' pro!essK D Ae /onHt nee/ to name

ever) instan!e tat !o"l/ appen D -"st te ones Ae &noA abo"t.

=.&.1 General Go+ernance

7!!or/in' to : Aor&in' r"les, te atten/an!e at all meetin's so"l/ be open to all

intereste/ parties, Ait information abo"t meetin' times an/ !onne!tion /etails !ir!"late/

on an open basis. :oAever, a'ainst tis ba!&'ro"n/ it is important tat te #$% $ro-e!t

/efine smaller 'ro"ps Ait i/entifie/ members Ao Aill ta&e on responsibilities for

parti!"lar s"btas&s. *e i/entifie/ membersip of ea! 'ro"p so"l/ be present an/

!ons"lte/ Aen /e!isions Aitin te remit of te 'ro"p are ma/e. *e vieAs of oter

atten/ees an/ te Ai/er $ro-e!t Wor&in' Gro"p so"l/ be ta&en into !onsi/eration.

16


17/21

Wen nee/e/, in/ivi/"al s"b'ro"ps !an es!alate iss"es to te $ro-e!t ea/ersip *eam

for resol"tion.

=.&.& ro*ect Lea/ers>i- Team

*is team is responsible for settin' te overall ob-e!tives, s!ope an/ timelines for te

pro-e!t an/ for or'anisin' reso"r!es to !arr) o"t te Aor&. *e team is responsible forens"rin' tat in/ivi/"al s"b teams are set "p an/ reso"r!e/ to !omplete s"btas&s an/ for

a!tin' as an arbitration 'ro"p to resolve iss"es tat arise Aitin te $ro-e!t.

For e?ample, te pro-e!t plan Aill i/entif) te &e) tas&s an/ timelines for /eliver). *e

$ro-e!t ea/ersip *eam is responsible for i/entif)in' people to Aor& in s"bteams to

!omplete tas&s, for monitorin' pro'ress on te !ompletion of tas&s via te s"bteam

lea/erHs reports an/ for resolvin' iss"es tat mi't affe!t te ;"alit) or timeliness of te

!ompletion of a tas&.

*e *eam is !ompose/ of te Intereste/ $arties, te $ro-e!t Fa!ilitator an/ te lea/ers of

te in/ivi/"al s"bteams. It is note/ tat one person ma) ave more tan one role Aitin

te $ro-e!t an/ be present in tis team representin' more tan one role.

*e *eam so"l/ ele!t a !airperson to r"n teir meetin's. *e *eam so"l/ !reate

min"tes from teir meetin's i/entif)in' a!tions an/ /e!isions ta&en.

*e *eam so"l/ meet at least on!e a mont b) tele!onferen!e, alto"' it is re!o'nise/

tat /"rin' parti!"larl) b"s) perio/s for te pro-e!t a more fre;"ent s!e/"le of meetin's

ma) nee/ to be establise/.

=.&. ro*ect #or4in$ Grou-

*e $ro-e!t Wor&in' Gro"p is ma/e "p of all intereste/ parties in te #$% $ro-e!t. *e

$ro-e!t Wor&in' Gro"p Aill meet b) tele!onferen!e ever) tAo Aee&s. *e meetin's

serve a m"lti p"rpose role, in!l"/in'>

$rovi/in' "p/ates on te 'eneral pro'ress of te pro-e!t

$rovi/in' a pla!e for te sarin' of information betAeen te vario"s pro-e!t

s"b'ro"ps

$rovi/in' a /is!"ssion for"m for iss"es tat s"b'ro"ps Ais to raise to a Ai/er

a"/ien!e

7'en/as for te Wor&in' Gro"p meetin's so"l/ be !ir!"late/ at least 24 rs in a/van!e

an/ i/entif) topi!s for presentation an/ /is!"ssion. 9otes from ea! meetin', i/entif)in'

/e!isions an/ a!tions an/ &e) /is!"ssion points, so"l/ be !ir!"late/ Aitin 24 rs of te

!lose of te meetin'.

It is note/ tat te remit of te Wor&in' Gro"p is ;"ite broa/ an/ te main intent is to

provi/e a 'eneral level of information to all intereste/ parties. 7s a res"lt, it is also note/

tat Wor&in' Gro"p meetin's are not 'enerall) te best pla!e to ol/ in /ept an/

len't) /is!"ssions on spe!ifi! topi!s "nless te impa!t is one tat as te potential to

impa!t te Aole pro-e!t. *e lea/er of te Wor&in' Gro"p meetin' is en!o"ra'e/ to alt

17


18/21

/is!"ssions tat be!ome too len't), /etaile/ or move off topi! an/ as& smaller 'ro"ps to

folloA "p te /is!"ssions an/ report ba!& to te Aor&in' 'ro"p.

=.&.2 Sub$rou-s

*e $ro-e!t %"b'ro"ps are smaller teams set "p to a//ress parti!"lar tas&s i/entifie/ in

te pro-e!t plan. 7 feA of te main s"b'ro"ps tat are e?pe!te/ to be nee/e/ ave beeni/entifie/ beloA. :oAever, te Wor&in' Gro"p an/ ea/ersip *eam !an a"torise te

settin' "p of oter s"b'ro"ps as nee/e/ to a//ress spe!ifi! tas&s.

3a! s"b'ro"p so"l/ i/entif) a lea/er Ao !an report ba!& to te Wor&in' Gro"p an/

also be a member of te ea/ersip *eam Aile te s"b'ro"p is Aor&in'. n!e te tas&s

of a s"b'ro"p ave been !omplete/ te s"b'ro"p Aill be /isban/e/ an/ te lea/er Aill no

lon'er be a member of te ea/ersip *eam.

3a! s"b'ro"p is responsible for settin' teir oAn meetin' s!e/"les an/ or'anisin' te

Aor& assi'ne/ to tem. %"b'ro"ps ma) be able to "se te : /ial in n"mber for

tele!onferen!es or te) ma) ave to ma&e alternate arran'ements.

3a! s"b'ro"p is responsible for /o!"mentin' te Aor& tat te) /o to an appropriate

stan/ar/ for te pro-e!t as a Aole. *e $ro-e!t Fa!ilitator Aill Aor& Ait te s"b'ro"p

lea/er to ens"re tat timelines are a/ere/ to an/ /eliverables i/entifie/ an/ pro/"!e/.

%ome of te e?pe!te/ s"b'ro"ps are>

#e;"irements s"b'ro"p B #esponsible for /evelopin' an/ /eliverin' te

re;"irements for te stan/ar/ to te mo/ellin' 'ro"p.

Mo/ellin' s"b'ro"p B #esponsible for ta&in' te re;"irements an/ mo/ellin'

tem in te : stan/ar/.

#$% #2 %*6 *estin' s"b'ro"p D #esponsible for testin' te #$% #2 %*6

stan/ar/. *is 'ro"p Aill nee/ to report ba!& to te #$% # pro-e!t on te

pro'ress of teir testin' an/ it is propose/ tat te lea/er of tis s"b'ro"p so"l/

be invite/ to te #$% # ea/ersip *eam.

*estin' s"b'ro"p B #esponsible for !arr)in' o"t an) testin' i/entifie/ in te

pro-e!t plan on te # stan/ar/ as it is /evelope/.

ter s"b'ro"ps ma) be forme/ to a//ress items s"! as spe!ifi! re'ional re;"irements,

/evelopment of spe!ifi! /o!"ments an/ pro!ess '"i/es, et!.

=. "n/i+i/ual Roles an/ Res-onsibilities

*e #$% # $ro-e!t %!ope %tatement i/entifie/ te folloAin' roles

$ro-e!t fa!ilitator Geoff Williams (3F$I7+ D 'eoff.AilliamsLro!e.!om

ter intereste/ parties Joe Cipollina ($#M7+ BJosep.CipollinaLpfizer.!om

Gar) Gensin'er (F7+ D

18
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19/21

Gar).Gensin'erLf/a.s.'ov

Geoff Williams (3F$I736+ D'eoff.AilliamsLro!e.!om

%tan van 5el&"m (36 #e'"lators+ B !a.v.bel&"mL!b'B

meb.nl

*a&" Watanabe ($M7+ B AatanabeBta&"Lpm/a.'o.-po"is 5o"la) (:ealt Cana/a+ B o"is.5o"la)L!B

s!.'!.!a5ernie iebler (7/vaMe/+ D 5ieblerL7/vaMe/.or'

=arin %ailor (Me/troni!+ B

&arin.sailorLme/troni!.!om

Mo/ellin' fa!ilitator Jason #o!& B-ason.ro!&L'lobals"bmit.!om

$"blisin' fa!ilitator $e'') eizear Dpe'').leizearLf/a.s.'ov

omain 3?pert #epresentatives *o be i/entifie/ from te #$% # Wor&in' Gro"p, as

nee/e/

#e;"irements pro!ess fa!ilitator *o be i/entifie/

*e $ro-e!t %!ope %tatement also in!l"/e/ te folloAin' roles, b"t tese ave not been

i/entifie/ as &e) to te #$% # pro-e!t an/ ave not been fille/ for te start of te

pro-e!t> Vo!ab"lar) Fa!ilitator, ata 7nal)st Fa!ilitator, 5"siness #e;"irement 7nal)st

*e folloAin' se!tion /es!ribes te roles in more /etail

=..1 ro*ect Facilitator;

*e person in tis role so"l/ f"lfil te tas&s of a pro-e!t mana'er an/ is responsible for

mana'in' te /eliver) of te pro-e!t as /efine/ in tis plan an/ an) f"rter s"pportin'

/o!"ments, in!l"/in' te !ompletion of all tas&s an/ te /eliver) of all i/entifie/

/eliverables

*is role so"l/ ens"re tat s!e/"le/ meetin's ta&e pla!e a!!or/in' to a planne/

a'en/a an/ pro/"!e notes, a!tions an/ min"tes, as appropriate. 9ote> it is not ne!essar)

tat te $ro-e!t Fa!ilitator be personall) responsible for !reatin' an/ !ir!"latin' a'en/as,

nor so"l/ te) ne!essaril) ave to pro/"!e te notesmin"tesa!tions. :oAever, te)

so"l/ ens"re tat te person Ao is assi'ne/ tese tas&s !ompletes tem.

*is role so"l/ ave a Aor&in' &noAle/'e of : pro!e/"res to ens"re tat minim"m

stan/ar/s are a!ieve/ in te /eliver) of te pro-e!t.

*is role so"l/ ave some /omain e?pertise in te area of ele!troni! s"bmissions

!reation an/ mana'ement to assist in te mana'ement of te pro-e!t.

*is role ma) nee/ to !ommit B80 of teir time to te tas&s i/entifie/

=..& "ntereste/ arties

*e people i/entifie/ as Intereste/ $arties represent te &e) sponsor an/ sta&eol/er

'ro"ps parti!ipatin' in te pro-e!t. *e people in tis role Aill serve as te main

members of te $ro-e!t ea/ersip *eam an/ are 'enerall) responsible for representin' a

19
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20/21

sta&eol/er 'ro"pHs (re'"lator) a'en!), in/"str) tra/e asso!iation, in/"str) 'ro"p, et!.+

interests in te pro-e!t an/ so"l/ i/eall) ave been nominate/ b) tat 'ro"p.

=.. Mo/ellin$ Facilitator

*e Mo/ellin' Fa!ilitator so"l/ !air te Mo/ellin' s"b'ro"p an/ ta&e responsibilit)

for te /eliver) of tat s"b'ro"pHs tas&s.=..2 ublis>in$ Facilitator

*e $"blisin' Fa!ilitator assists te $ro-e!t ea/ersip *eam in mana'in' te

/o!"ments for p"bli!ation on te : Aebsite in s"pport of te ballot pa!&a'es.

=..3 Domain E


21/21

Communication/

Corresponence

"esponsi)le

Party

"ecei!ing

Party*ies+

Fre$uency Metho o&

Communication

Meetin' 7'en/a Meetin'

Fa!ilitator

7ll 24 o"rs

prior toMeetin' (K+

$oste/ to #$% #

Wi&i D Meetin'pa'e

Meetin' Min"tes Meetin'Fa!ilitator

7ll 24 o"rsafter te

Meetin' (K+

$oste/ to #$% #Wi&i D Meetin'

pa'e

#e;"irements

7rtefa!ts

#e;"irements

Fa!ilitator

7ll 7s /evelope/ $oste/ to #$% #

Wi&i D

#e;"irements

pa'e

#BMIM Mo/ellin'

Fa!ilitator

7ll 7s /evelope/ $oste/ to #$% #

Wi&i Development

pa'e

21

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