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Investigator/Site Information Form

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INVESTIGATOR/SITE INFORMATION FORM
ATTENTION: Celeste Moreno
FAX NUMBER: N/A
EMAIL ADDRESS: celeste.moreno@!"nt"les.com
DATE: #$%M&'%(#)* NUMBER OF +AGES: ),
+le&se ret!rn com-lete. /orm to 0eleste Moreno 1"t2"n t1o 3(4 5!s"ness .&'s o/ rece"-t.
For your convenience, please use the first page of this form as your cover sheet)
STUD6 ): +rotocol )$7%)8%()#: A Phase 3b, Multi!enter, "an#omi$e#%ith#ra%al, Pla!ebo!ontrolle#, &ouble
blin#, Parallelgrou' (rial to Com'are the )ffi!a!* an# Safet* of (olva'tan +,PC-1./1, /. to 10. mg/#a*, s'lit #ose1
in Sub2e!ts %ith Chroni! 3i#ne* &isease bet%een 4ate Stage 0 to )arl* Stage - #ue to Autosomal &ominant
Pol*!*sti! 3i#ne* &isease5
STUD6 (: +rotocol )$7%)8%()): A Phase 3b, Multi!enter, ,'en4abel (rial to )valuate the 4ong(erm Safet* of
(itrate# Imme#iaterelease (olva'tan +,PC-1./1, 3. mg to 10. mg/#a*, s'lit #ose1 in Sub2e!ts %ith Autosomal
&ominant Pol*!*sti! 3i#ne* &isease5
T2e enrollment 9o&ls /or t2"s st!.' &re (750 patients overall, and an average of 5 patients per site over 6 months).
+le&se com-lete &ll sect"ons t2&t re!"re "n/orm&t"on &n. correct &n' "n&cc!r&te "n/orm&t"on t2&t 2&s &lre&.'
5een -o-!l&te. so t2&t 1e m&' !-.&te o!r .&t&5&se. 0om-let"on o/ t2"s s!r:e' .oes not 9!&r&ntee select"on
/or t2"s st!.'. Some !est"ons m&' not &--l' to 'o!r co!ntr'.
+6C5 InvP 6uestion 01
&r5 Mr5 Ms5
Professor Mrs5 Miss
Firstname
4astname
)mail
Phone
Fa7
+6C5 InvP 6uestion 31
Institution Name
Investigator A##ress1
Investigator A##ress0
Investigator A##ress3
Investigator Cit*
Investigator State/Provin!e
Investigator 8i'/Postal Co#e
Countr*: Argentina, Australia, 9elgium, 9ra$il, Cana#a, C$e!h "e'ubli!, Fran!e, :erman*, Ital*, Netherlan#s,
Nor%a*, Polan#, "omania, "ussia, S'ain, S%e#en, S%it$erlan#, (ur;e*, <nite# 3ing#om, <nite# States
+le&se "n."c&te 'o!r "nterest "n -&rt"c"-&t"n9 "n t2e st!.' ) 3+rotocol )$7%)8%()#4:
De/"n"tel' "ntereste. ; 1o!l. l"<e to -&rt"c"-&te
Uns!re "/ I 1o!l. -&rt"c"-&te
De/"n"tel' NOT "ntereste. ; 1o!l. not -&rt"c"-&te
De/"n"tel' "ntereste. ; 1o!l. l"<e to -&rt"c"-&te
Uns!re "/ I 1o!l. -&rt"c"-&te
De/"n"tel' NOT "ntereste. ; 1o!l. not -&rt"c"-&te
Please in#i!ate reason+s1 for being unintereste# belo%:
Proto!ol #esign !on!erns/issues +if 'roto!ol available1
in!lusion/e7!lusion 'roto!ol !onfli!ts %ith stan#ar# of !are
'roto!ol #esign stu#* too #iffi!ult
Investigator/Site Information Form
Page 0 of 7
Please 'rovi#e #etails if *ou have ti!;e# an* of the bo7es above

<nable to a!!ommo#ate
!om'eting stu#ies !hange of fa!ilities
la!; of staff/resour!es long ethi!s/"egulator* Authorit* timelines
la!; of sub2e!t 'o'ulation no !on#u!t of this stu#* t*'e
no longer #oing resear!h PI no longer at site
no time/not ta;ing stu#ies PI retire#
,ther +'lease s'e!if* =========================
If *ou have ti!;e# the bo7 PI no longer at site > 'lease 'rovi#e the name of re!ommen#e# PI for re'la!ement:

+le&se "n."c&te 'o!r "nterest "n -&rt"c"-&t"n9 "n t2e st!.' ( 3+rotocol )$7%)8%())4:
De/"n"tel' "ntereste. ; 1o!l. l"<e to -&rt"c"-&te
Uns!re "/ I 1o!l. -&rt"c"-&te
De/"n"tel' NOT "ntereste. ; 1o!l. not -&rt"c"-&te
De/"n"tel' "ntereste. ; 1o!l. l"<e to -&rt"c"-&te
Uns!re "/ I 1o!l. -&rt"c"-&te
De/"n"tel' NOT "ntereste. ; 1o!l. not -&rt"c"-&te
Please in#i!ate reason+s1 for being unintereste# belo%:
Proto!ol #esign !on!erns/issues +if 'roto!ol available1
in!lusion/e7!lusion 'roto!ol !onfli!ts %ith stan#ar# of !are
'roto!ol #esign stu#* too #iffi!ult
Please 'rovi#e #etails if *ou have ti!;e# an* of the bo7es above

<nable to a!!ommo#ate
!om'eting stu#ies !hange of fa!ilities
la!; of staff/resour!es long ethi!s/"egulator* Authorit* timelines
la!; of sub2e!t 'o'ulation no !on#u!t of this stu#* t*'e
no longer #oing resear!h PI no longer at site
no time/not ta;ing stu#ies PI retire#
,ther +'lease s'e!if* =========================
If *ou have ti!;e# the bo7 PI no longer at site > 'lease 'rovi#e the name of re!ommen#e# PI for re'la!ement:

+6C5 SP 6uestion ?.1
+le&se c2oose /rom t2e /ollo1"n9 to .escr"5e 'o!r s"te sett"n9. +le&se select &ll t2&t &--l':
Publi! @os'ital &e#i!ate# "esear!h Center
Private @os'ital Site Management ,rgani$ation +SM,1
<niversit* @os'ital/A!a#emi! Center ,ut'atient fa!ilit*
<niversit* Stu#ent @ealth Center In'atient fa!ilit*
Chil#renAs @os'ital (ertiar* Care Center
)mergen!* "oom B4argeB (ertiar* Care Center
<rgent Care Center B(ravel Clini!B that !aters to families
Private Clini! Militar*/CeteransD Affairs @os'ital
Private Pra!ti!e
Investigator/Site Information Form
Page 3 of 7
+6C5 InvP 6uestion 71
+r"m&r' S-ec"&lt'
Internal Me#i!ine Internal Me#i!ine
,ther > ,ther
Please s'e!if* Primar* S'e!ialt* if *ou have ti!;e# ,ther ,ther

++6C5 InvP 6uestion ?1
Secon.&r' S-ec"&lt'
Internal Me#i!ine > Ne'hrolog*
Bo&r. 0ert"/"e.=
Ees
No
Not A''li!able
+6C5 SP 6uestion F1
+le&se enter t2e M&ster 0ont&ct .et&"ls:
Master Site Conta!t First Name
Master Site Conta!t 4ast Name
Master Site Conta!t Phone Number
Master Site Conta!t )mail A##ress
G Master Contact is person who should be main point of contact for siteinvestigator
%% SITE EX+ERIEN0E AND >UALIFI0ATIONS ;
@as *our 'ra!ti!e/institution ever been ins'e!te#/au#ite# b* a "egulator* Authorit*H Ees No
If *es, 'lease s'e!if*: ===============================================
(If applicable and within your country laws and regulations, can you please provide a copy of the
inspection report (e.g., FDA Form 4!))=
@o% man* stu#ies in A<(,S,MA4 &,MINAN( P,4ECES(IC 3I&N)E &IS)AS) +A&P3&1 are *ou !on#u!ting
at 'resentH
a1 A''ro7imatel* ho% man* stu#ies have *ou %or;e# on in this thera'euti! areaH
b1 @o% long have *ou been !on#u!ting !lini!al trialsH
!1 @o% man* of *our !urrent stu#ies %oul# !om'ete for enrollment %ith this stu#*H
Please s'e!if* the stage an# number for ea!h:
Start<'
"e!ruitment
Maintenan!e
Close ,ut
+if none, s;i' Iuestion #1
#1 Provi#e estimate# #ate+s1 of enrollment !om'letion for !om'eting stu#ies +if a''li!able1:
===============================================
Investigator/Site Information Form
Page - of 7
+6C5 InvP 6uestion 1FF1
Ne-2: +le&se "n."c&te 12et2er t2e "n:est"9&tor 2&s 0LINI0AL e?-er"ence "n &n' o/ t2e /ollo1"n9 3c2ec< &ll
t2&t &--l'4:
A!ute renal im'airment
Chroni! renal anemia
Chroni! renal im'airment
)n# stage renal #isease
@*'er'hos'hatemia
Ne'hritis
Pol*!*sti! ;i#ne* #isease
Proteinuria
"enal failure s*n#rome
<rolithiasis
+6C5 InvP 6uestion 1F/1
Ne-2: +le&se "n."c&te 12et2er t2e "n:est"9&tor 2&s RESEAR0@ e?-er"ence "n &n' o/ t2e /ollo1"n9 3c2ec< &ll
t2&t &--l'4:
A!ute renal im'airment
Chroni! renal anemia
Chroni! renal im'airment
)n# stage renal #isease
@*'er'hos'hatemia
Ne'hritis
Pol*!*sti! ;i#ne* #isease
Proteinuria
"enal failure s*n#rome
<rolithiasis
@o1 m&n' -otent"&l s!5Aects .o 'o! 2&:e 1"t2 AD+BD=
From t2ose -&t"ents 1"t2 AD+BDC 2o1 m&n' meet t2e /ollo1"n9 cr"ter"&:
have famil* histor* of A&P3&, an# %ith several !*sts 'er ;i#ne* +3 if b* ultrasoun# ," F if b* C( or M"I1
,"
#o not have famil* histor* of A&P3& an# have 1. !*sts 'er ;i#ne* +b* an* ra#iologi! metho#1

have never been treate# %ith tolva'tan
have 'reviousl* been treate# %ith tolva'tan
I/ 'o! 2&:e -&t"ents t2&t 2&:e -re:"o!sl' 5een tre&te. 1"t2 tol:&-t&n or -&rt"c"-&te. "n & tol:&-t&n
-ro9r&m st!.'C -le&se "n."c&te t2e st!.' 3or st!."es4 t2&t t2e' 2&:e -&rt"c"-&te. "n:
()MP, +Proto!ol 1F/.-0F.1
()MP, +Proto!ol 1F/.-0F11
()MP, +Proto!ol 1F/.-0711
Proto!ol 1F/.J0?0
Proto!ol 1F/.J0?-
Proto!ol 1F/.J0?F
No!turne +Proto!ol 1F/.J0J.1
,C)"(<") +Proto!ol 1F/1.0J11
other +'ls s'e!if*1
(a;ing the 'rimar* in!lusion/e7!lusion !riteria into a!!ount +e:F"C3&)PI bet%een 0F an# /F m4/min/1573m
0
+1? to
FF *ears1 or e:F"C3&)PI bet%een 0F an# -- m4/min/1573m
0
+F/ to K // *ears, b* me#i!al monitor #is!retion
onl*1, 'lease estimate ho% man* 'otential eligible sub2e!ts *ou !oul# realisti!all* enroll 'er monthH
sub2e!ts/month, an# ho% man* 'atients %oul# *ou !ommit to enroll in total H +%ith
!om'etitive enrollment an# given all enrollment to be !om'lete# b* 31 &e!ember 0.1-1
Investigator/Site Information Form
Page F of 7
Please in#i!ate the 'er!entage of 'atients *ou inten# to re!ruit from ea!h of the follo%ing sour!es5
=======L Patient #atabase
=======L "eferrals from other 'h*si!ians
=======L (ra#itional a#vertising +e5g5, ne%s'a'er, ra#io, (C1
=======L ,nline a#vertising +e5g5, 'osting on !lini! %ebsite, email1
=======L ,ther:=============================
Are *ou !on!erne# about retaining 'atients on this stu#*H
Ees, an# %ill nee# assistan!e %ith retention tools5
Ees, but #o not nee# assistan!e %ith retention tools5
No, %e are not !on!erne# about 'atient retention5
Please 'rovi#e #etails %hat !an !ause an* !on!erns about retaining 'atients on this stu#*M

+6C5 SP 6uestion 1-1
+le&se "n."c&te 12"c2 o/ t2e /ollo1"n9 -"eces o/ e!"-ment &re &:&"l&5le /or cl"n"c&l st!."es &t 'o!r s"te.
+le&se select &ll t2&t &--l':
&e#i!ate#, 4o!;able ?. #egrees Celsius Free$er
&e#i!ate#, 4o!;able 7. #egrees Celsius Free$er
&e#i!ate#, 4o!;able 0. #egrees Celsius Free$er
&e#i!ate#, 4o!;able "esear!h "efrigerator
Ambient Centrifuge
10 4ea# )le!tro!ar#iogram +)3:/)C:1 ma!hine
Calibrate# Neight Measurement &evi!e +S!ale1
@eight Measurement &evi!e +Sta#iometer1
+6C5 SP 6uestion 3-1
Does 'o!r s"te 2&:e t2e /ollo1"n9= +le&se c2oose &ll t2&t &--l':
@igh s'ee# internet
Nireless high s'ee# internet
Plain 'a'er fa7 ma!hine
(ou!h tone tele'hone
Printer
S!anner
Photo!o'ier that is a!!essible to the monitor
&e#i!ate# !oor#inator s'a!e %ith internet a!!ess
&e#i!ate# monitoring s'a!e %ith internet a!!ess
&e#i!ate# lo!;e# s'a!e for trial materials
A !om'uter that !an be use# for !om'leting me#i!al re!or#s
A !om'uter that !an be use# for online !om'letion of eC"Fs
+6C5 SP 6uestion 701
+le&se "n."c&te 12"c2 o/ t2e /ollo1"n9 c&-&5"l"t"es 'o!r s"te 2&s 3c2oose &ll t2&t &--l'
(esla 15F Magneti! "esonan!e Imaging +M"I1
(esla 3 Magneti! "esonan!e Imaging +M"I1
,ther Magneti! "esonan!e Imaging +M"I1
"a#iolog* su''ort for ra#iologi! #iagnosis
<ltrasoun#
Com'ute#/Com'uteri$e# (omogra'h* +C(1
Pharma!o#*nami! biomar;ers
&o *ou have a!!ess to:
@ome !are nursing to 'erform stu#* 'ro!e#ures at home Ees No
A#a'tive !lini! hours for 'atients %ho %or; Ees No
&o *ou have a re!ommen#e# !olleague *ou %or; %ith %ho !an hel' 'erform
stu#* 'ro!e#ures regionall* in or#er to minimi$e 'atient travelG
Ees No
GIf *es 'lease s'e!if* !onta!t #etail +Name, Institution a##ress, email, 'hone number1 of the referral !olleague if
available
Investigator/Site Information Form
Page / of 7
Is this eIui'ment lo!ate# %ithin *our fa!ilit* %here sub2e!ts %ill re!eive stu#* treatmentH Ees No
If N,, 'lease s'e!if* the lo!ation an# #istan!e +number of miles/;ilometers1 of the eIui'ment from *our
fa!ilit* an# if the lo!ation is rea#il* a!!essible to *our stu#* 'atients

+6C5 SP 6uestion 111
Does 'o!r s"te 2&:e .e."c&te.C loc<e. s-&ce /or &m5"ent In:est"9&t"on&l +ro.!ct stor&9e=
Ees No
+6C5 SP 6uestion -71
Does 'o!r s"te 2&:e t2e &5"l"t' to collectC -rocessC &n. s2"- 3-&c<&9e &n. l&5el4
+2&rm&co<"net"c/+2&rm&co.'n&m"c 3+B/+D4 s&m-les=
Ees No
A 5loo. s&m-le m&' 5e collecte. /or Genet"c DNA test"n9 3o-t"on&l -roce.!re4. Are t2ere &n'
c2&llen9es o5t&"n"n9 &--ro:&l /or o5t&"n"n9C 2&n.l"n9C or s2"--"n9 t2ese s&m-les &t 'o!r s"te/co!ntr'
35' t2e Mo@C IRB/E04=

Ees No
+6C5 SP 6uestion 13.1
Does 'o!r s"te 2&:e &.e!&te co:er&9e /or &ll "n:ol:e. -ersonnel 3+r"nc"-&l In:est"9&torC St!.' 0oor."n&torC
+2&rm&c"stC etc.4 "n t2e e:ent o/ 2ol".&'/"llness/In:est"9&tor Meet"n9sC etc.=
Ees No
135 Please summari$e the e7'erien!e of *our SubInvestigator+s1 an#/or stu#* !oor#inator+s1 in the table belo%:
Name Full (imeH
+E/N1
Eears of
e7'erien!e in this
thera'euti! area
Eears of !lini!al
resear!h
e7'erien!e
Number of
!urrent
stu#ies




+6C5 SP 6uestion 1.31
Does 'o!r s"te 2&:e t2e &5"l"t' to !se & 0entr&l Inst"t!t"on&l Re:"e1 Bo&r./Et2"cs 0omm"ttee=
Ees
Ees, onl* in some !ases
No
If you answered "#es$ or "#es, only in some cases,$ please provide the name of the central I%&'()*


If you answered "+o$ above!
&oes *our site/institution reIuire more than one I)C/I"9 a''rovalH Ees No
If OEes,P ho% man* su!h a''rovals are ne!essar*H
If OEes,P are these !ommittees able to revie%/a''rove in 'arallel %ith the I)C/I"9H Ees No
+6C5 SP 6uestion 1.-1
Investigator/Site Information Form
Page 7 of 7
For s"tes t2&t !se Loc&l IRBs/E0s 3Inst"t!t"on&l Re:"e1 Bo&r.s/Et2"cs 0omm"ttees4C 2o1 o/ten .oes 'o!r
IRB/E0 meet=
More than on!e 'er %ee; 1 time 'er month
,n!e 'er %ee; less than on!e 'er month
3 times 'er month Not a''li!able +site uses Central I"91
0 times 'er month

Nhat is *our submission #ea#line for a s!he#ule# I)C/I"9 meetingH
1 %ee; 'rior 0 %ee;s 'rior 1 month 'rior ,ther +s'e!if*1
Nhat is the average %aiting time for *our I)C/I"9 #e!isionH
4ess than one %ee; 10 Nee;s 0- %ee;s D- %ee;s
+6C5 SP 6uestion 1.01
On &:er&9eC 2o1 lon9 .oes t2e contr&ct ne9ot"&t"on &n. s"9n&t!re -rocess t&<e &t 'o!r s"te=
Nithin -? hours /1J. #a*s +03 months1
07 #a*s J110. #a*s +3- months1
?1- #a*s +0 %ee;s1 1011?. #a*s +-/ months1
1F3. #a*s +3- %ee;s1 More than / months
31/. #a*s +10 months1

+6C5 SP 6uestion 301
Does 'o!r s"te 2&:e Electron"c D&t& 0&-t!re 3ED04 e?-er"ence=
Ees No
If *es, 'lease s'e!ifi! )&C s*stems: ============================================================
Does 'o!r s"te 2&:e e?-er"ence 1"t2 Me.".&t& RAVE ED0 s'stem=
Ees No

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