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Site Pro■ le Form
Purpose of Site Profile fornl: The intent of the Site Profile form is to capture site capab‖ ities that are co‖ ected during sitequalification and not to replace current individual pre― study activitiest The intent is to reduce the administrative burden on sites

associated with completing multiple forms requesting the same or similar information, The form is notintended to capture study
specific or therapeutic specific information,
The form wili be in an electronic format′ with drop dovvn o「 check boxesto keep the form simple and easy to use.There will be freetextinput boxes for providing any necessary explanationsi Site should keep a copy ofthe completed form on filet
if additionaltextis needed in any of responses′

use an asterisk and enter atthe bottom ofthe formt

1.COMPLETED BY:
Fu‖ Name:

IR9nttoYokoyatta

Date Compに によ

陶7

Rdα

investigator Name:￨
2.SiTE DETAlL:
Okinawa Prefectural Chubu Hospkal

institution Name:
Address tLocation〕

City::

u「 uma‖State/Region/Province:10kinawa

Countrw l」 apanTypα

Postal CodαPu朋 に卜 OS耐 創

Therapeuttc Area: 区 Autoimmune rx‐ cardlovascular
区胸04セ 293

tt Ctttical Care tt Dermatology tt infectious Disease

Menis Health FX Metabollc/Endocttne tt Wuscu10Skeletal tt Neuroscience XOncology

X Pain tt Pediatrics tt PSychiatry tt Respiratory

tt Vacdnes

ヌ OsteoporOsis

tt Vir010gy tt WOmentS heatth

Other:
Trial phase capabilities:

Xl

区 11FX‐tHてiV Other areas of expertise:
めDo yOu have attiliated research sites or satellite sites/ctinicsP瞬 NoⅨWVhich different sponsor typets)dO you have research experience?

invesugatOrinitiated F None

区 industry tt Academに「Ethnicity of patient population tt please break down vour population by%of ethnicity
apanease(950/0)￨」

Demographtts of paHent popuLHoni FX

PedtttHc tt Adutt Other comments:i

停::辞 品
七
塩幡部ment agency or part of a govemment ttnded hettth service?「肥醍8製‖
Site Contacts:

First Name:Yes X NoPrimary s■ e co,ractrOrcrinた 。
′triars

IRenzoSurn3me:IYokoyama

W,7Witrθ 抑5Cererθ tebFθ β力θrttθ Fttcicθ ηPhOnα 1484‐ 98‑973‑打 11

Fa対Email:lyokoyama̲renzO@hosp p「屯 げ 5‑卜割●伊973‐ ■24

ef.o間 nawa.jp

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COMMlTTEE REViEW PROCESS
performing the ethics conimittee submission.

PART A‐ This section is only applicable if the site is directly responsible fo「lRB/ERB/Ethics COmmに
committee
tee陥mαF爾̲cRy: lurutta

而 縞 面 高mu Hosp ttt htttut on創 陥Mew

粘1号:ibn/10ttawa

Address:

Country:￨」 aPanlRB/ERB/Ethics committee registration number tif applicable〕

PostalCodα 19o4‑2293
lRB/ERB/Ethics committee type:l central X Local tt centrayacts as iocal

Name: IRenzoYokoyama
PhOnα

Does yOur site have a separate departmentthat handles

iRB/ERB/Ethtts commktee SubmissionsP tt Yes「lf yes′ pleaseNo1484 98 973‐ ■ 11帥

provide contact information for this department

1肺to the right ofthe form

い 朝mひ w"酬 mpincluding whether any

Please provide a general outline ofthe steps required to obtain approvalfor a study at yourinstitution/site′el orin sequence. Please ensure that the fo‖ owing
steps are covered′ in addition to any other app‖ cable administrative steps required at your site texample― contract/budget
approwaL scientific review committees,etca)―lRB/ERB/Ethics commtttee{S)meeung schedule/frequency
steps are dependent on one another′

and/orifthey can be completed in para‖―Amount of umein advance of an iRB/ERB/Ethics commに

tee meetlng that all documentatton must be submttted―Amount of Hme following an iRB/ERB/Ethics commtttee review you receive wtttten conlrmaJon Of approval―Does yOuriocallRB/ERB/Ethics committee require payment of any fees ahead of submission or pttOrto the release ofthe nnal approval documentsP‐lRB meeting schedule/frequency!The second Tuesday of each month‐Amount oftime in advance of an iRB that a‖
documentation must be submittedi 1 5 business days before lRB holding―Arnount oftime fo‖ owing an iRB review yOu receive written confi「 mation of approvaに VVthin 7 buisiness days
―Does yOuriocallRB requi「 e payment of any fees ahead of submission or priorto the release ofthe final app「 oval documents?:NoneB̀this section is only applicable if the site is NOT responsible for directly performing ethics comnlittee subnlissionsi

provide a general outline ofthe steps required to obtain approvalfor a studv at yOurinstitution/site,including whether anv

are dependent on one ancther,and/orifthey can be completed in para‖ el orin sequence texample‐ contract/budget approval,
割
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Does yOur site have a written soP,poHcy/procedure forinfo『med Consent?.

.

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Minor Assent for pediatric populations■ ..."".・ """""・・・
・""・・・・"・・・・・・・・・・・・・・・・・・"・・・●
Other vuinerable populations?.
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5.SiTE QUALiFiCAT10NS/TRAIN:NG

千X YeslNoYeslNoYes

ヌ No

区 Yes
区 Yes

W‖ i vour site require language transiations fo『 consents......・・・・・・・…
・・・・・・・・・・・・・・……
・・"・・・・・・・・・・・・・・・・・・・・・・・・・・・・' No

区 Yes

‐十 No
ヤ
「 Noにd?円 eぉ etti ttapanese

Does yOur site have a training program forthe research stattP ,......"HDoesthe course content hclude CCP?.…

・"・・・・・・・・""・・ ・区・・・・・・・………………………………………………………

Does yourttte use an external program to conduct research trainingP r yes,pに

ase pro胡 de program「 course name:再ves

Does yOur program have a pro胡 軒
on for training statt when updates to protocols occur?.… ……

wwwir何 抑scererotebFθ βわo「mttr7cicθ 何‑2qメ 5‑『Yes tt Nott No

5た e pro/ire Fθ rlm y 3.2:Febrげ θr/ユ 身2θ ユ4

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LOCAL LAB:
Name/Detailsi Local LabPhonα

卜坪̲?9や 7Ψ llFa濫

割9897い 」24
いLocal ttb accredRajon l GLP F CHAドEmail:

CAP「 lSO区

other l」 M〜 JAMT,pMA

Does the study staffthat prepares or transports dangerous goods have training that meets thelATA international Air Transport Association tUS〕
or Other countries hazardous training
requirements for shipping dangerous goods? .......・ ・●
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・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・●…●"●EQUIPMENT:Yes「is Calibration of equipment done routinely?.....".● ●
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H"・・・・"・・"・・・・・・"・・・・"・・・コ・"●… "● ●●" ●Do yOu have nonttfrost‐ free freezers fo「 biological sample storage?口 ....H.・・・""H・・"・"""・・・" ・Do yOu have refrigerators for biological sample storage?..."…
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Are records and ca‖ bration frequency available?.

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ls there temperature monitoring for refrigerators?.....● ●
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is there a back‐ up plan for a power outage of refrigerato『 s and freezers?.… …".....・ "・ コH"。・ "・・"His the system alarmed ifthe equipmentis out of range fo「 refrigerators and freezers?."...... ・・・・・
Do yOu have accessto an ECG?.
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・・・・・・・・・・・・・・・・・・ ・・・・・・・・・・・・・・・・●●""● ●…●ls there temperature monitoring for freezers P...

Are records maintained and available?.

Do yOu have..

.・.."・

区 External phone lines Xinternattonal phone lines

Do yOu have a centrifuge for processiab samples?.… ……Ⅲ●
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Do you have refrigerated centrifuge for processing iab samplesP.… ..… …
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1・

ド No FX N/A区Yes
Nolx ves 「r‐ No

20
区‐
ほYes

70「 N/A区‐
No「:::開半浮帯Yes
No
区房てYes 「NoYes 「tt No「 区 YesNo

ほ Yes 「NoNo

区 Ves「「COMPUTER CAPABlLITY:
Does yOur site have dedicated computers for the research studies?.…

……………………………………

Ⅸ;Ves

No
「Does yOur site have internalfirewa‖ sP....."..● ●
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Does yOur site have high speed internet access?.…
Does yOur site have wireless internet capabilkiesP.…

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区 Yes

No・・…………・……………………………………………。

区 ves 「No....・「OTHER:

ヌVes
PK/PD capabilky?.… ……………………………………………………………………………………
No・
Lab hoursto accommodate PK/PD studに s beyondい ‐5,M‐ け … …… …… …… …… … …… … … … …… X Yes「 Noにyourske open on weekends?.… ………………………………………………………………………, X Yes tt No「‐‐Are vou able to admit research subjects to an in‐ patient setting fOr research purposesP.… ……….
区 Yes 「 No.…

D:GlTAL D:ACNOSTlC CAPABILiTlES:※ CTヌ MRI戸 PET ttX‐ ray tt DXA l Othertpに aSe lに t}￨

STORAGE FACiL:TlES:
is the onsite padent record賞 orage secured to protect pajent pttvacy?.H…
Are the archiving faci‖ ties on site?

………………………

X Yes

No,市 o打 封te proude name and iocaJon informatbn.

※ YesNo「「is there storage area on ttte for study related mateHals,ex.Lab ttts or other■

WM/Witrθ ttscererareが θp力 θrmθ ttc.cθ 何emsl.… …………………区 Ves‑3θ 5‑√F No

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fす ナ
務観腐 お〔g′Ship to address:

OP"A用 初 A′ 円C

281,Aza‐ iyazato,Uruma― city,Okinavva,904‑2293,」 apan
Okinawa Prefectural Chubu Hospkal
rr、Prirnary

PhOnα 卜甲 ギ伊9各 打 何Contact:lcenterforCiinical Research

Fax卜 樹‑98‐ 97伊 ■24
区 Yesstorage bca百 on the same as the shipping address?tr study Specttc sttp}

F No区 Ves

NoEmail: lchuburesearch@hOSp pref ottnawaJp

infutton capa断 lRY?.… ……………………………………………………………………………
………・

「No
区 ves
「tt RefrigeratorFreezer

is the lP storage area secured wRh controlled accessP.… ……………………………………………

L the temperature monko問 ng avaiLbに forthe fdbwing?
Please detailtemperature device capabilkies tfor eXample―区 Room temp

『min/max)′ frequency for monた oring,lmin/max,every day

FX YesNoYesNo「区「図 Yes F No

is the temperature monitoring alarmed in the event that there is an excursion?...

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ls your site adequately staffed to perform both blinded and unablinded roles,in case un‐blinded
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drug rnonitoring is requiredP.........・・ ・●
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・・・・・・・・・・・・・=… …
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ls there backup plan in the event of a power outage or equipment failure?.....・

8.QUEST10NS SPECiFiC TO DESTRUCT10N OFlPFX Yes

Does yOur site have the capability to destroy lP on site/arranged directly via subacontractor?.....

Does yOur site have a written SoP/po‖ cy/procedure fo「 IP destructionP,....…・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
IP― SATELLITE SiTE tS)

区 Yes「No 「N/A

No 再 N/A

Yes r No 区 N/A
No 区 N/A「 r Yes

Wili the satellRe sitets)haVe a dedicated inventOry?
Do vou have a drug transportation procedure for sate‖ ite sitesP「
9.QUEST10N SPECiFiC TO CONTROLLED SUBSTANCES
Does the site have the regulatoPy required licenses or registrations to receive,store,dispense

and retum controlled substances as required by bcal bw?.… … …… …… … ……… Ⅲ… … H… … Ⅲ… Ⅲ…

区 VeS

The storage fac‖ ity for contro‖ ed substances is secureiv constructed with restricted access toprevent the化 or d巾 ersion?.… …………………………………………………………………………
・Radio labeled IP capab‖

ity?1......

・・・・・・・・・・・・・・

ed substancesP

Does yOur site have the capability to destroy IP on site for contro‖

Source documents:Are ske source documents
Please list any access limita甘Paper

戸 N/ANo 挿N/ANo 再N/ANo l N/Att Bothons/requirements for the「electronic medical records「智柵創路瀧 譜l樫Electronic「Ⅸ Yes
区 Yes「区 Yes「「Norecords

Wili monた ors have access to区 PhOne

ヌ F3X

What electronに data systems has your statt used for dinkaltriaにOther,JeaSe lに t

IX Copy machines?

区 inform

tt internet access

ttMedidata Rave

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Please provide anv additionalinfo『 mation not captured eisewhere on this fornl,that yOu feelisimpOrtantthat we should know
about your site.Please reference section number if applicable:

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Site Pro/ile Fθ rm yヨ .2f Feb円 oり 互492θ ユ