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

Facility Name

National Hospital Organaization Oita Medical Center

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

Nutritional and Metabolic Diseases
Respiratory Tract Diseases

Pain
Oncology

Infectious Diseases
Vaccines
Women’s Health

Sub-Therapeutic Areas:
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.

Yes

No

What study types does your Facility have experience with?
Academic

Investigator
Other Other
Government
Initiated
Is your Facility affiliated with a government agency or part of a government funded✔

Industry

health service?

Yes
No
Not 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 100%___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 1 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________
IRB/ERB/ETHICS COMMITTEELess than 30
30-60
61-90
What is the average time (in days) to start a study once
you have received the regulatory package?
Greater than 120
91-120
Does your Facility perform IRB/ERB/Ethics Committee
submissions?

Yes

No

Does your Facility have a dedicated department or groupto perform IRB/ERB/Ethics Committee submissions?

Yes

No

Yes

No

Department Contact Name

Clinical trial management room

Department Contact Phone Number+81-97-593-2701

Department Contact Email AddressNAIs your Facility able to initiate study activities prior to IRB/ERB/Ethics
Committee protocol approval?
What types of IRB/ERB/Ethics Committee does your Facility
use? (Select all that apply.)

✔

Local

✔

Sponsor Provided Central

Does your institution and/or local regulation mandate the distribution ofsafety reports [e.g., development Safety Update report (DSUR),
suspected unexpected serious adverse reaction(SUSAR) to a local Review Only IRB/ERB/Ethics Committee?
Are there any other steps that the Sponsor should be aware of for yourIRB/ERB/Ethics Committee review and submission?

✔

Central Acting as Local

Yes

No

Yes

No

If Yes, provide details about the role various committees play in yoursite's review and submission process. If you have multiple local IRBs,
explain what drives the decision on which IRB to use.
15 copies of deliberation materials are required.

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SIP Facility Profile Form_________________________________________________________________________________________________________________
Local IRB/ERB/Ethics Committee
IRB/ERB/Ethics Committee Name

National Hospital Organaization Oita Medical Center Institutional Review Board

Street Name and Number

2-11-45,yokota

Building/Floor/Room/Suite

National Hospital Organization Oita Medical Center

Additional Address InfoCountryJapan

State/Province/Region

Oita

City

Oita City

Zip/Postal Code

870-0263

Registration No.

Registering Body

NA

What is the meeting frequency of your Local
IRB/ERB/Ethics Committee?

WeeklyTwice a Month

4XDUWHUO\

Other

1 week2 weeks

How long before IRB/ERB/Ethics Committee review is
the Submission Packet required?

Monthly

Greater than 2 weeks

Does the IRB/ERB/Ethics Committee require payment
prior to release of final approval documents?
Does the IRB/ERB/Ethics Committee require contract/budget
approval prior to release of final approval documents?

Yes

No

Yes

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.

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SIP Facility Profile Form_________________________________________________________________________________________________________________
REVIEW ONLY IRB/ERB/ETHICS COMMITTEEIRB/ERB/Ethics Committee Name
Street Name and Number
Building/Floor/Room/Suite
Additional Address InfoCountry- Select Country -State/Province/Region- Select State -City
Zip/Postal CodeRegistration No.

Registering Body

Note: Additional Review Only IRB/ERB/Ethics Committees can be added online from the Facility Profile in SIP.

OTHER REVIEW BOARDS
Does your Facility have other review boards that need to approve
the study prior to IRB/ERB/Ethics Committee submission?
For example, scientific, radiation safety committees, or others.

Review Board Name

Yes

No

Meeting Frequency
WeeklyTwice a Month

Quarterly

Other

WeeklyTwice a Month

Quarterly

Other

MonthlyMonthly___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 4 of 17 -

SIP Facility Profile Form_____________________________________________________________________________________________________________________________

LOCAL LAB
Is your Facility using a local lab?
Lab NameNo

Yes
Department Of Laboratory

Lab Contact First NameLab Contact Last Name
Street Name and Number

2-11-45,yokota

Building/Floor/Room/Suite

National Hospital Organization Oita Medical Center

Additional Address InfoCountryJapan

State/Province/Region

Oita

City

Oita City

Zip/Postal Code

870-0263

Phone Number+81-97-593-1111

Fax Number+81-97-593-3106

Email Address

NA

Local Lab Accreditation (Select all that apply)
None

GLP

CLIA

CAP

ISO

✔

Others

JMA

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

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SIP Facility Profile Form_____________________________________________________________________________________________________________________________CONSENT AND TRAININGCONSENT
Does your Facility have a written SOP/Policy/Procedure for: Informed Consent?

Yes

No

Does your Facility have a written SOP/Policy/Procedure for: Other vulnerable

Yes

No

Yes

No

Yes

No

If located in the US, has your Facility used or are you able to use the informed

Yes

No

consent short form?

Don't Know

populations?
Does your Facility have a written SOP/Policy/Procedure for: Minor Assent forpediatric populations?
Will your Facility require language translations for consents?
Note: Languages can be selected online from the Facility Profile in SIP.

Not Applicable
TRAINING
Does your Facility have a training program for the research staff?

Yes

No

Does the course content include GCP?

Yes

No

Does your Facility use an external program to conduct research training?

Yes

No

Do you have a process or program in place to retrain research staff when aprotocol is amended?

Yes

No

Does the study staff that prepares or transports dangerous goods have trainingthat meets the IATA International Air Transport Association (US) or othercountries hazardous training requirements for shipping dangerous goods?

Yes

No

Please provide program course name:eAPRIN___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 6 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________
FACILITY AND EQUIPMENT
FACILITY CAPABILITIESCan your Facility support patient visits on weekends?

Yes

No

Can your Facility support in-patient admissions for research studies?

Yes

No

Does your study staff have sufficient English knowledge to understandcommunications in English?

Yes

No

Does your Facility have access to translators and translation support
for study conduct (e.g. consent, study specific instruction)?

Yes
No
Not Applicable

Does the Facility have storage space for Study-Related materials(e.g. Lab Kits, Patient Materials, etc.)?

Yes

No

Does your Facility have the ability to collect and store PK/PD specimens?

Yes

No

Does your Facility have the ability to collect PK/PD samples beyond normal
business hours?

Yes

No

Does your Facility typically allow the collection of Pharmacogenomic (PGX)
samples for research purposes?

Yes

No

.
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SIP Facility Profile Form_________________________________________________________________________________________________________________EQUIPMENT
Identify the Diagnostic Equipment available at or near the Facility to support Research studies?
(Check all that apply.)NA

Not Applicable✔

CT ScanComputerized Tomography Scan✔

DXA

Dual-Energy X-ray Absorptiometry or Bone Densitometry✔

ECG/EKG

Electrocardiogram

✔

FLRO

Fluoroscopy✔

MRI

Magnetic Resonance Imaging✔

MRA

Magnetic Resonance Angiography (MRA)

MRS

Magnetic Resonance Spectroscopy (MRS)

✔

MAMMO

Mammography

✔

NMED

Nuclear medicine (e.g. Bone scan, thyroid scan, thallium cardiac stress test)

PET

Positron Emission Tomography Scan

X-ray

X-Radiation

Other

Other

✔

Describe any additional equipment relevant to Clinical Trials:

GENERAL EQUIPMENT
Does your Facility have an SOP or process that ensures routine calibrationand maintenance of general equipment? Examples of general equipment
include: scale, pulse oximeter, stadiometer, sphymomanomer, etc.?
Does your Facility have the necessary equipment to treat medical emergencies(ie. code cart)?

Yes

No

Yes

No

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 8 of 17-

SIP Facility Profile Form_________________________________________________________________________________________________________________
Identify the equipment available at the Facility to support Research studies?
✔

Centrifuge✔

Refrigerated Centrifuge✔

Refrigerator (2 to 8 Degrees C)
Equipment Capabilities: Refrigerator (2 to 8 Degrees C)
Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

No

Does this equipment have a temperature alarm?

Yes
Yes

Do you have an SOP which supports calibration of this equipment?

Yes

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

DailyFreezer (-20 to -30 Degrees C)
Equipment Capabilities: Freezer (-20 to -30 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

✔

- Select -Freezer (-70 to -80 Degrees C)
Equipment Capabilities: Freezer (-70 to -80 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

DailyFreezer (Liquid Nitrogen -135 Degrees C)
Equipment Capabilities: Freezer (Liquid Nitrogen -135 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?

- Select -NoNo____________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 9 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________COMPUTER CAPABILITIES
Yes

Does your Facility have computers which are dedicated to research studies?
What type of computer operating system(s) does your institution use to support studies?
✔

Windows (Windows XP, Windows 7, Windows 8, etc)
Apple/Mac (OS X Snow Leopard, Mountain Lion, El Captain, etc)
Unix/Linux (Solaris, Ubuntu, Redhat, etc)
I don’t know
Other

What type of internet access does your Facility have?

Wi-Fi

Does your Facility limit or prohibit access and use of external web-based tools
or sites for clinical research (E.g. web portals to submit documents to sponsors
or CROs)?

Yes

Does the Facility have access to local IT support?

I don't know___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 10 of 17 -No

SIP Facility Profile Form_________________________________________________________________________________________________________________INVESTIGATIONAL PRODUCT & CONTROLLED SUBSTANCESINVESTIGATIONAL PRODUCT SHIPPING DETAILSIP Recipient Name

National Hospital Organization Oita Medical Center Clinical trial management room

Street Name and Number

National Hospital Organization Oita Medical Center

Building/Floor/Room/Suite

2-11-45,yokota

Additional Address InfoCountryJapan

State/Province/Region

Oita

City

Oita City

Zip/Postal Code

870-0263

Phone Number+81-97-593-1111

Fax Number+81-97-593-2701

Email Address

takezoe.tatsuya.wb@mail.hosp.go.jp___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 11 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________INVESTIGATIONAL PRODUCT STORAGE LOCATION
IP Storage Location Name
Street Name and Number
Building/Floor/Room/Suite
Additional Address InfoCountry- Select Country -State/Province/Region- Select State -City
Zip/Postal CodePhone Number
Fax Number
Email Address
Note: Additional Investigational Product Storage Locations can be added online from the Facility Profile in SIP .

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SIP Facility Profile Form_________________________________________________________________________________________________________________INVESTIGATIONAL PRODUCT STORAGE EQUIPMENT
Identify the Investigational Product Storage Equipment at your Facility✔

Refrigerator (2 to 8 Degrees C)
Equipment Capabilities: Refrigerator (2 to 8 Degrees C)
Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

Do you have the ability to generate a temperature monitoring log for this equipment?

Yes

No

Does this equipment provide Min/Max Temperature Monitoring?

Yes

No

Does this equipment have back-up power?

Yes

No

Does this equipment have a temperature alarm?

Yes

No

Do you have an SOP which supports calibration of this equipment?

Yes

No

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

HourlyFreezer (-20 to -30 Degrees C)
Equipment Capabilities: Freezer (-20 to -30 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

- Select -Freezer (-70 to -80 Degrees C)
Equipment Capabilities: Freezer (-70 to -80 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

- Select -Freezer (Liquid Nitrogen -135 Degrees C)
Equipment Capabilities: Freezer (Liquid Nitrogen -135 Degrees C)

How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.

- Select -___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 13 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________INVESTIGATIONAL PRODUCT STORAGE & HANDLINGIs the Investigational Product Storage Room secured with controlled access?

Yes

No

Yes

No

Yes

No

Does the Investigational Product Storage Room have back-up power?

Yes

No

Does the Investigational Product Storage Room have a temperature alarm?

Yes

No

Yes

No

Yes

No

Does your Facility have a written SOP/Policy/Procedure for destruction of

Yes

No

Investigational Product?

Not Applicable

Do you provide your Satellite Site(s) with a dedicated inventory ofYes

Investigational Product?

Not Applicable

Does your Facility have a written SOP/Policy/Procedure to ensure that

Yes

Investigational Product is appropriately maintained during transportation to

Not Applicable

Do you have the ability to generate a temperature monitoring log for thisInvestigational Product Storage Room?
Does the Investigational Product Storage Room provide Min/Max temperaturemonitoring?

Do you have an SOP which supports calibration of the temperaturemonitoring equipment?
Does your Facility have the ability to manage on-site or off-site destructionof Investigational Product?

Satellite Site(s)?
Describe additional Investigational Product Storage & Handling Capabilities:___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 14 of 17 -No

No

SIP Facility Profile Form_________________________________________________________________________________________________________________
PREPARATION AND ADMINISTRATION OF INVESTIGATIONAL PRODUCT
Identify the Investigational Product preparation capabilities at your Facility:✔

Extemporaneous Preparation✔

Vertical laminar flow hood (chemo/hazardous drugs)
Glove box (non-vented)
Horizontal laminar flow hood (non-hazardous drug preparation)
Glove box (vented to outside)

Preparation and Administration of Investigational ProductIs your Facility capable of administering infusions?
Is your Facility adequately staffed to support studies with both blinded and unblinded Investigational Product?

Yes

No

Yes

No

CONTROLLED SUBSTANCES
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.
Does the Facility have the required licenses or registrations

Yes

No

to receive, store, dispense and return controlled substances

Not Applicableas required by local law?
No

Is the storage area for controlled substances securely constructed

Yeswith restricted access in accordance with local law?

Not Applicable

Does the Facility have the ability to handle radio-labelled

Yes

No

Does your Facility have the ability to manage on-site or

Yes

No

off-site destruction of controlled substances when appropriate?

Not Applicable

Investigational Product?

ATTACHMENTS
Upload relevant Investigational Product & Controlled Substances documentation including: relevant SOPs
for managing or storing Investigational Product(s), IP storage equipment, or licenses/registrations toreceive, store, dispense and return controlled substances.
Note: Attachments can be uploaded online from the Facility Profile in SIP.

___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 15 of 17-

SIP Facility Profile Form_________________________________________________________________________________________________________________SOURCE DOCUMENTATIONSOURCE DOCUMENTS
What type of source documents will be used? (Select all that apply):

✔

Paper

✔

Electronic

Does your Facility have secure storage for patient records?

Yes

No

Does your Facility have patient record archiving on-site?

Yes

No

Provide Location name and address of any offsite archives.

ELECTRONIC MEDICAL RECORDS (EMR) /ELECTRONIC HEALTH RECORDS (EHR)
Do you have Electronic Health Records (EHR)/ Electronic Medical Records (EMR)?

What EMR/EHR system do you use?

✔

Yes

In-house system

No
OthersNote: Please select other options for EMR/ EHR used at your Facility online.

For Facilities with satellite sites, where is the monitor required to
Selectaccess source documents?

Please list any access limitations/requirements for the Electronic Medical Records:___________________________________________________________________________________________________________SIP Facility Profile Form v3.0 Last Updated 05-Nov-2018- Page 16 of 17 -

SIP Facility Profile Form_________________________________________________________________________________________________________________MONITORING
Check all equipment that will be available to Monitors:✔ Phone✔ Fax✔ Copy Machines
None✔

Internet Access

What Electronic Data Capture (EDC) systems has your staff used for clinical trials?
None

Oracle Inform✔

Medidata Rave

Oracle Remote Data Capture (RDC)

OthersDescribe Other EDC Systems:

ADDITIONAL INFORMATION AND ATTACHMENTS
ADDITIONAL INFORMATION
Please provide additional information not captured in other sections of the Facility Profile that you feel isimportant for Sponsors to know about your Facility. Please reference the section name, if applicable.

FACILITY ATTACHMENTS
Upload any non-study specific Facility documents that have not been included in other sections of the
profile. Lab, IRB/ERB/Ethics Committee, Investigational Product and Controlled Substance
documentation should be included in those sections. The document type drop-down list provides
examples of the type of documentation to be included in this section.
Note: Attachments can be uploaded online from the Facility Profile in SIP.

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