SIP F ili

Profile Form_________________________________________________________________________________________________________________
Note: Invalid phone numbers and email address if entered in text fields in the form shall not be populated in SIP.
Shimane University Hospital

THERAPEUTIC AREAS AND PATIENT POPULATIONTHERAPEUTIC AREA(S) Provide the list of Therapeutic Areas for your Facility:
Bacterial Infections and Mycoses
Cardiovascular Diseases
Digestive System Diseases

Endocrine System Diseases
Eye Diseases

Hemic and Lymphatic Diseases
Immune System Diseases

Male Urogenital Diseases
BoneMental disorders

Sere i Are s

上記以外はSub-Therapeuticで選択

Note: Sub-Therapeutic Areas can be selected online from the Facility Profile in SIP.

Other Areas of Expertise:

STUDY PHASE CAPABILITIES✔

Phase I✔

Phase II✔

Phase III✔

Phase IVOTHER FACILITY DETAILSDo you have Affiliated Research Sites or Satellite Sites/Clinics? A Satellite Site is asecondary location where the investigator sees clinical trial subjects. Usually this is thesame investigator who sees subjects at the primary site location.

YesNo

What study types does your Facility have experience with?
AcademicInvestigator
Other OtherGovernment
Initiated
Is your Facility affiliated with a government agency or part of a government funded✔

Industry✔

health service?

YesNoNot Applicable

PATIENT POPULATION
Patient Population Demographics✔

Pediatrics - Less than or equal to 17 ✔ Adults - Ages 18-64 ✔ Geriatrics - Greater than or equal to 65

Patient Population Comments:
Japanese >99%, Others <1%___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Peof 7

Profile FormSIP F ili_________________________________________________________________________________________________________________oise er e ime is os re re ei ee re l ore

oes o rilis missio ssoessere ererform IRB ERB E i s Commi eeoes o riliee i e e r me or roo erform IRB ERB E i s Commi ee s missio sesNoesNoClinical Research Center, Clinical Trial Management Oﬃce81-853-20-2744
tiken@med.shimane-u.ac.jp

Is o rili
le o i i i e s
Commi ee ro o olro lsei i ies rior o IRB ERB E i s

es of IRB ERB E i s Commi ee oes o r F ili
Selelll✔

oes o r i s i ioor lo l re l io mes fe re or s ee elo me S fe Ue re ors s e ee e e serio serse re io
SUSAR o le is ri
SURAre ereo er s e s
IRB ERB E i s Commi ee re iereS o sor s o ls missioeeso lio of✔

NoCe r l A is o lesNoesNo___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Peof 7SIP F ili

Profile Form_________________________________________________________________________________________________________________Local IRB/ERB/Ethics Committee
IRB/ERB/Ethics Committee Name

Shimane University Hospital Institutional Review Board
89-1, Enya-cho- Select Country - Select State -Izumo693-8501

is e mee i
IRB ERBfreeofee l
Quarterlyo loefore IRB ERB E i se S missio P e re ireoes e IRB ERB E i s Commi ee re irerior o rele se of fi lro l o me sre ie is21re ermeoes e IRB ERB E i s Commi ee re ire o rro l rior o rele se of fi lro l o me seee sesNoes

No

Note: Attachments can be uploaded online from the Facility Profile in SIP.
Note: Additional Local IRB/ERB/Ethics Committees can be added online from the Facility Profile in SIP.

CENTRAL ACTING AS LOCAL IRB/ERB/ETHICS COMMITTEE
Note: Central Acting as Local IRB/ERB/Ethics Committee can be selected online from the Facility Profile in SIP.

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Peof 7SIP F ili

Profile Form_________________________________________________________________________________________________________________RE IEW ONLY IRB/ERB/ETHICS COMMITTEEIRB/ERB/Ethics Committee Name- Select Country - Select State -Note: Additional Re ie

nly IRB/ERB/Ethics Committees can be added online from the Facility Profile in SIP.

OTHER RE IEW BOARDS
oes o r F ilieer e ieo r see oro eesrior o IRB ERB E i s Commi ee s missioFor e m le s ie ifi r i io s feommi ees or o ers

esNoRe ie Bo r N meee li eooOtherQuarterlyee lyea

Quarterlyththly

Other___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Peof 7l

SIP F ili

Profile Form

LOCAL LAIs o r F ili

silo l lNoes

Clinical Laboratory Division, Shimane University Hospital
Emi

Sato

S ree N me

N m er

B il iloor oom S i eAi iolACorS89-1, Enya-choress- Select Country -e- Select State -Ci

Izumo
693-8501

i Pos l Co e
P o e N m er

81-853-20-2419

F81-853-20-2423

N m er

Em il Aresso l

A re itiken@med.shimane-u.ac.jp

ioSelelllJapanese Committee for Clinical Laboratory Standards

No eP

C IACAP✔

IS✔

er

Note: ttachments can be uploaded online from the acilit Profile in SIP.
Note: Additional Local Labs can be added online from the Facility Profile in SIP.

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Peof 7

Profile FormSIP F ili
CONSENT AND TRAININGCONSENToes o r F ilieri e S P PoliPro e

re for I forme Co seesNooes o r F ilieri e S P PoliPro e

re foreri e S P PoliPro e

re forire le roerl erlees

Noi or AsseforesNoes

NoesNol io s

oes o r F ili
e i riol io s

ill o r F ili

resl io s for o se s

Note Languages can be selected online from the Facility Profile in SIP.

If loo see ie USs o r F ilise orle o see i formes or formooNo AlileTRAINING
oes o r F ilioesee o rse o eoes o rser i iile er

Ple se ro i e ro r m o rsero r m fors ffe CPl ro r m o orese rr i ies

Noes

Noes

Noes

Noes

NoeAPRIN

meo oero ess or ro r m iro o ol is me e
oes e smee so riese rese rl e o re r i rese rs ffes ff
re res or r s or sero s oo se r i ie IA A I er io l Air r s or Asso i io US or o err o s r i i re ireme s for s i iero s oo s___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 6 of 7

Profile FormSIP F ili_________________________________________________________________________________________________________________FACILITY CAPA ILITIECo r F ilisorie

Co r F ili

sor i

isi s oieee esmissio s for rese r

oes o r ss ffe s ffi ie
omm i io s i E lisE

oes o r F ilifor sosl orsrs e ifi i s roeseeeess o ro se slise F ilie s or e se for Si s P ieeri ls e

oes o r F iliee

ilio olle

oes o r F ili
si ess o rseeilio olle

oes o r F ili
s m les for rese ri ll llor oseso leesNoiesesNoersesNoesNo ANolese osl io sioorliRel e m eri lses

Nos ore P P s e ime sesNoorm les

NoP Xes

NoP P s m les e oe olle io of P

rm o e omi.
____________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 7 of 7

Profile FormSIP F ili_________________________________________________________________________________________________________________E UIP ENT✔

C S✔

XANo AliComeri el E eromo r
X r

SA sor iome r or Bo e e si ome r

✔

EC

✔

F R

✔

RIe i Resoe Imi✔

RAe i ResoeAio r

RA✔

RSe i Resoe S e ros oRS

✔

A

✔

N EN

✔

PEPosi ro Emissio✔

X rX R✔

E

leEle ro r io r m
Fl oros ommo rerle r me i i e eo esomo rroi slli mr is ress esSi ioerescribe an additional e uipment relevant to linical rials:

ENE AL EQUIPMENToes o r F ilieS P or ro esse s res ro i e li r iom i ee of e er l e i meE m les of e er l e i mei l e s lelse o ime er s iome er smom omer eoes o r F iliie o e ree e ess r ei meo reme i l emer eiesesNoesNo___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 8 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________I✔

FCC✔

C✔

ECo ooeseis eo freCeilii mero i ee lo reoesis ei meoesis ei mee

re me s remesreooeseis eo freoeseir C eiliem ersor so e er ero i ee lo oo reli r io ofis eiem eri me

re mo i ori

re me s remese

S P

em ersD✔

or sreooeseis eo freoeso e er ero i er C e

li r io of

S Pioeseis eo freo oili

i mee lme s remeoesem ersor sis e

NoesNoesNoesNoesNoesNoesNoesNoes

Noes

Noes

Noes

Noes

Noes

NoesNoeses

Noeis ei meem erro i e

S PeioLissor sis ei meo i ori
r C ee mos freis ee- Select -i me

Cre mo i ori

em erem erlo forN

re me s reme

i mereli r io ofo e er eem ero rere mo i ori

re l rm

Ci meee mos fre

orDFeem erse

Co oi mere l rm

re me s remeNEes- Select -em eri mei me
eis eoriem ero reL✔

ilie lo oNo

Ci me

is eesCeme s remelo foro i ori

Co oNo- Select -re l rmem er

i me

i me

Eeori

em er

ee mos frees

Ci me

is ei meCeme s remeis eo i oriCo olo foro erDEre mo i ori

em eri me

S P✔

em eriem erme s remeo oo e er ereolo fori meo i orir C ee mos freorre l rmli r io ofis e

is ei mee- Select -esNoNo____________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 9 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________C MPUTE CAPA ILITIE
oes o r F ilie ome of omi✔

o sAU iiI oer o er iileersire e is s em so rese ro ri sio s XPio sSXS oeoroReeSol ris Ueio sei

El Cioses

iesiosieseoere of i er eess oes o r F ili

oes o r F ili limi or ro i ior si es for li i l rese r
Eeor CR soese F ilieeSelectessse of e er l ese oolsor ls o s mi o me s o s o sors

ess o lo l I sorSelectSelect___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 10 of 7

NoSIP F ili

Profile Form_________________________________________________________________________________________________________________IN E TI ATI NAL P

UCT & C NT

LLE

IN E TI ATI NAL P

UCTETAILIPPINUTANCE

Department of Pharmacy, Shimane University Hospital

S ree N meN m er

B il iFloor Room S i eAi iolACorSe Pro i89-1, Enya-choress I fo- Select Country -e Re io

Ci- Select State -Izumo

i Pos l Co e

693-8501

P o e N m er

81-853-20-2492

F81-853-20-2495

N m er

Em il Aress

tiken@med.shimane-u.ac.jp___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 11 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________S ree N me

N m er

B il iFloor Room S i e

Ai iolACor

Se Pro iress I fo- Select Country -e Re io- Select State -Ci
i Pos l Co e
P o e N m er
FN m erEm il Aress

Note: Additional In estigational Product Storage Locations can be added online from the Facility Profile in SIP .

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 12 of 7

SIP F iliProfile Form_________________________________________________________________________________________________________________IN E TI ATI NAL PIUCT T

A E EQUIPMENTPEIFC✔

ECo oeoesis eo freeilii meis eo oo e er ero i ee lo reeiem erseS P

re mo i ori

re me s remei mei meem eriem erme s remeoesCem ersor sreolo foris ei meo i orir C ee mos freeoris eNoes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

Noes

No- Select -re l rmli r io ofesi meCECo oeoesis eo freeilii meis eo oo e er ero i ee lo reeiem erseS P

re mo i ori

re me s remei mei meem eriem erme s remeoesCem ersor sreolo foris e

i meo i orir C ee mos freeor- Select -re l rm
li r io ofis ei meCECo oe

oesis eo free

is eo e er ero i ee lo oFili

i meo ree

Liem erso oe
is eo fre

ili

i me

e lme s remeo oFeis ei meo i orir C ee mos free- Select -re l rm
li r io ofro i eem ero re

S PLo e er eis ei meeiiNem ersem ersor sC

re mo i ori

em er

re me s remei mei meeois eCCoesor srelo fororNEoesem erseS P

re mo i ori

re me s remei mei meem eriem erme s remeoesC

reolo foris eo i ori
r C ee mos freorre l rmli r io ofi meis ei mee- Select -___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 13 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________IN E TI ATI NAL PIsIeIes iiol Proo oeeilies iiol ProoeseI

UCT T

A E&AN LIN

S ore Room sereo e er eS orem erio rolleessesNoesNoesNoesNoesNoesNoioesNoio ofesNoe or ofesNo

re o e s reesNore mo i ori

lo forise Roomes iiol

S ore Room ro i eiem er

remo i orioeseI

es iiol

S ore RoomeoeseI

es iiol

S ore Roomeior sli r io ofe em ero oe

S Pmo i oriei meoes o r F iliof Ies iioeIiliomeri e S P Poli

es iioo oro i e o r S elli e Si e ses iioes iio

re l rmree o si e or off si e es rPro e

re for es rl Proie ie il Pro

oes o r F ili
Ieem erl Pro

oes o r F ili
Iso erl Proeri e S P Poli
isro ri el m iPro ei erirs oriooNo AliS elli e Si e sescribe additional Investi ational Product Stora eandlin

apabilities:___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 14 of 7leSIP F ili

Profile Form_________________________________________________________________________________________________________________P EPA ATI N ANA MINI T ATI NI e ifiol Proeo s Prer ioeIes iE em or✔
✔

✔

er i l l mir flooolo e ooe eori ol l mir flolo e oe ePre

F IN E TI ATI NAL Pr ioili iesemor o s rsor o s rooUCTo r F ili

rer ioo o si eAIIs o r F ilile ofPmi is erii f sio so r F iliC NTLLEUesNoesNoTANCE

Controlled Substances are defined as: A drug or chemical whose manufacture, possession, or use is regulated bya government, such as illicitly used drugs or prescription medications that are designated a Controlled Drug.
oese F ili

eo re ei e s ores reIsis e seire li e ses or re is r io sesre r

No Ao rolle ssesNolilelo l le s oriIiree ree re for o rolle sres ri e

ess ioese F ilies iioeses seore ilo l liliole riliome

relo sreNoesNo Alileelle

esNoe o si e oresNoio ll Prooes o r F ilioff si e es ree

io of o rolle ssesero ri e

No Alileio ili

ATTAC MENTU lorele

Ifor mior s orire ei e s ore

es iis e seioIl Proes ire rCo rolle Siol Proo rolle sss IP s orses oeei memerele

S Psor li e ses re is r io s oesNote: Attachments can be uploaded online from the Facility Profile in SIP.

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 5 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________U CE

CUMENTATI NU CE

CUMENTe of so r e ome s ill e seseoes o r F ili
Pro i e oELECTioere s orie

E Ress so r e oiei illls elli e si es✔

re or so si eoffsi e ri es

ELECTNIC

EALTseNote: Please select other options forFor F ili ies irress ofNIC ME ICAL EC

E R E R s s em o oe forre ormeSele✔

✔

Ele ro iesNoesNoECEHRIo se s s em

used at our Facilit online.

ere ise mo i or reireoSelectme s

Please list any access limitations re uirements for the lectronic

edical ecords:

Personal ID and password___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018

Pe 6 of 7

SIP F ili

Profile Form_________________________________________________________________________________________________________________M NITC e✔

INll eNo ei meille oo i orsCoEle ro iNo eescribeill eCre E C s s ems✔

theri esI er e A esss o r s ff se for li i l ri ls✔

✔

r le Remo eCreers✔

S stems:

Cube CDMSDATATRAKAITI NAL INF

MATI N ANA

ITI NAL INF

MATI NPle se ro i eim ori io

ATTAC MENTl i form iofor S o sors oooore i o er se io s ofo r

Ple se refereee F ili

Profilee se iome ifo feel islileFACILITY ATTAC MENT

Note: Attachments can be uploaded online from the Facility Profile in SIP.

______________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018Pe 7 of 7