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Site Profile Form
Purpose of Site Profile form: The intent of the Site Profile form is to capture site capabilities that are collected during sitequalification and not to replace current individual pre-study activities. The intent is to reduce the administrative burden on sites
associated with completing multiple forms requesting the same or similar information. The form is not intended to capture study
specific or therapeutic specific information.
The form will be in an electronic format, with drop down or check boxes to keep the form simple and easy to use. There will be freetext input boxes for providing any necessary explanations. Site should keep a copy of the completed form on file.
If additional text is needed in any of responses, use an asterisk and enter at the bottom of the form.
1. COMPLETED BY:
Full Name:

Akira Hashimoto

Date Completed:Role:

clinical trial office

Investigator Name:
2. SITE DETAIL:
Institution Name:
Address (Location):City:

Hokkaido University Hospital

Kita 14, Nishi 5, Kita-ku

SapporoState/Region/Province: Hokkaido

Country: JAPANType:

Postal Code:060-8648

Academic

Critical CareDermatology
Infectious Disease
Auto immune
Cardiovascular
Men's Health
Metabolic/ Endocrine
Musculoskeletal
Neuroscience
Oncology
Osteoporosis
Pediatrics
Psychiatry
Respiratory
Vaccines
Virology
Women's health
Pain
Other:

Therapeutic Area:

Trial phase capabilities:

III

IV other areas of expertise:III

Do you have affiliated research sites or satellite sites/clinics?

Yes

Which different sponsor type(s) do you have research experience?

NoIndustry

Academic

Investigator InitiatedNone

Ethnicity of patient population - please break down your population by % of ethnicity
Japanese: 99%, others: 1%

Demographics of patient population:

Pediatric

Adult

Other comments:

Is your site affiliated with a government agency or part of a government funded health service?
If Yes, please specify the affiliation

Yes

NoNational University Corporations

Site Contacts: Primary site contact for clinical trials
First Name: Akira

Phone: +81-11-706-7061

Surname: Hashimoto

Email: hassi@med.hokudai.ac.jp

www.transceleratebiopharmainc.com-1 of 5-

Fax: +81-11-706-7977

Site Profile Form v 3.2: February 19, 2014

3. ETHICAL COMMITTEE REVIEW PROCESSPART A - This section is only applicable if the site is directly responsible for performing the ethics committee submission.
IRB/ERB/Ethics committee
City: Sapporo
Name:
Address:

State/Region/Hokkaido
Province:
Country: JAPANHokkaido University Hospital Institutional Review Board
Kita 14, Nishi 5, Kita-ku

Postal Code: 060-8648
IRB/ERB/Ethics committee type:
CentralCentral/acts as local
Local

IRB/ERB/Ethics committee registration number (if applicable)

Name: Akira Hashimoto
Does your site have a separate department that handles
IRB/ERB/Ethics committee Submissions?
YesNo
If yes, please provide contact information for this department
to the right of the form

Phone: +81-11-706-7061
Email:

hassi@med.hokudai.ac.jp

Please provide a general outline of the steps required to obtain approval for a study at your institution/site, including whether any
steps are dependent on one another, and/or if they can be completed in parallel or in sequence. Please ensure that the following
steps are covered, in addition to any other applicable administrative steps required at your site (example – contract/budget
approval, scientific review committees, etc.)- IRB/ERB/ Ethics committee(s) meeting schedule/frequency- Amount of time in advance of an IRB/ERB/ Ethics committee meeting that all documentation must be submitted- Amount of time following an IRB/ERB/Ethics committee review you receive written confirmation of approval- Does your local IRB/ERB/Ethics committee require payment of any fees ahead of submission or prior to the release of the final approval documents?

- IRB/ERB/ Ethics committee(s) meeting schedule/frequency: The Third Tuesday / Once a month- Amount of time in advance of an IRB/ERB/ Ethics committee meeting that all documentation must be submitted: 2 weeks- Amount of time following an IRB/ERB/Ethics committee review you receive written confirmation of approval: 1week- Does your local IRB/ERB/Ethics committee require payment of any fees ahead of submission or prior to the release of the final
approval documents?: None

PART B- this section is only applicable if the site is NOT responsible for directly performing ethics committee submissions.
Please provide a general outline of the steps required to obtain approval for a study at your institution/site, including whether any
steps are dependent on one another, and/or if they can be completed in parallel or in sequence (example- contract/budget approval,
scientific review committees, or other, but excluding ethical committee or health-authority submissions handled directly by thesponsor/CRON/A or please, explain.

4. INFORMED CONSENT
Does your site have a written SOP, policy/procedure for Informed Consent? ...............................
Minor Assent for pediatric populations?.....................................................................
Other vulnerable populations?..................................................................................................
Will your site require language translations for consents ……………………………………………………………

Yes
Yes
Yes
Yes

No
NoNo
No

If so, what languages will be required? Please list. Japanese
5. SITE QUALIFICATIONS/TRAINING
Yes
No
Does your site have a training program for the research staff? ....................................................
No
Does the course content include GCP? .......................................................................................
Yes
Does your site use an external program to conduct research training? If yes, please provide program course name:Yes

NoJapan Society of Clinical Trials and Research: ICH E6 GCP Essential GCP Training Version 2.0(11/Oct/2017)

Does your program have a provision for training staff when updates to protocols occur?.............

www.transceleratebiopharmainc.com-2 of 5-Yes

No

Site Profile Form v 3.2: February 19, 2014

6. FACILITIES AND EQUIPMENT
LOCAL LAB:
Name/Details: Division of Laboratory and Transfusion Medicine
Phone: +81-11-706-5706

Fax: +81-11-706-7614

Email:Local lab accreditation

CAPISO
otherGLP
CLIA
Does the study staff that prepares or transports dangerous goods have training that meets theIATA International Air Transport Association (US) or other countr ies hazardous training
requirements for shipping dangerous goods? ……………………………………………………………………………
EQUIPMENT:Is Calibration of equipment done routinely? ……………………………………………………………………………..
Are records and calibration frequency available?........................................................................
Do you have non-frost-free freezers for biological sample storage?..............................................
Do you have refrigerators for biological sample storage?..............................................................
Is there temperature monitoring for refrigerators? ……………………………………………………………………
Is there temperature monitoring for freezers ?………………………………….........................................
Are records maintained and available?.......................................................................................
Is there a back-up plan for a power outage of refrigerators and freezers?...................................
Is the system alarmed if the equipment is out of range for refrigerators and freezers?................
Do you have access to an ECG? …………………………………………………………………………….……………………
Do you have
External phone lines
International phone lines
Do you have a centrifuge for process lab samples? …………………………………………………………………….
Do you have refrigerated centrifuge for processing lab samples? ………………………………………………

Yes

No

Yes
yes
-20
Yes
Yes
Yes
Yes
Yes
Yes
Yes

No
No
-70
No
No
No
No
No
No
No

Yes
Yes

No
No

COMPUTER CAPABILITY:
Does your site have dedicated computers for the research studies?.............................................
What is your current browser and adobe version? Please list:

Yes

No

Does your site have internal firewalls? ……………………………………………………………………………………….
Does your site have high speed internet access? …………………………………………………………………..……
Does your site have wireless internet capabilities?.......................................................................

Yes
Yes
Yes

No
NoNo

OTHER:
PK/PD capability? ……………………………………………………………………………………………………………..………
Lab hours to accommodate PK/PD studies beyond (8-5, M-F)? …………………………………………………..
Is your site open on weekends? ………………………………………………………………………………………………….
Are you able to admit research subjects to an in-patient setting for research purposes?..............

Yes
Yes
Yes
Yes

NoNo
No
No

N/A

N/A

Internet Explorer Ver.11 , Google Chrome ver.74, Adobe Acrobat DC

DIGITAL DIAGNOSTIC CAPABILITIES:
CT
MRI
PET
X-ray

DXA

Other (please list)

STORAGE FACILITIES:Is the onsite patient record storage secured to protect patient privacy? …………………………………….
Yes
Are the archiving facilities on site?
Yes
No, if offsite provide name and location information.

NoIs there storage area on site for study related materials, ex. Lab kits or other items?……………………………

No

www.transceleratebiopharmainc.com-3 of 5-Yes

Site Profile Form v 3.2: February 19, 2014

7. INVESTIGATIONAL PRODUCT (IP)Ship to address: Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Primary
Contact: Takahiro Koizumi , Kana Tsutsumi
Email:

Phone: +81-11-716-5799+81-11-716-5799

Fax:

cykanri@huhp.hokudai.ac.jp ; tsutsumi-c@huhp.hokudai.ac.jp

Storage location the same as the shipping address? (if study specific skip)
Infusion capability? ……………………………………………………………………………………………………………………
IP-STORAGE AND HANDLINGIs the IP storage area secured with controlled access? ……………………………………………………………….
Is the temperature monitoring available for the following?
Room temp
Refrigerator

Yes

NoNo

Yes

No

Yes

Freezer

Please detail temperature device capabilities (for example – min/max), frequency for monitoring.
①Recorded at 15-minute intervals(Calibrated)②Max/Min is recoede (1time/day)(Not Calibrated)

Is the temperature monitoring alarmed in the event that there is an excursion? ……………………….
Is there backup plan in the event of a power outage or equipment failure? ………………………………
Is your site adequately staffed to perform both blinded and un-blinded roles, in case un-blindeddrug monitoring is required? ………………………………………………………………………………………………………
8. QUESTIONS SPECIFIC TO DESTRUCTION OF IP
Does your site have the capability to destroy IP on site/arranged directly via sub-contractor?.....
Does your site have a written SOP/policy/procedure for IP destruction? …………………………………..
IP – SATELLITE SITE (S)Will the satellite site(s) have a dedicated inventory?
Do you have a drug transportation procedure for satellite sites?
9. QUESTION SPECIFIC TO CONTROLLED SUBSTANCES
Does the site have the regulatory required licenses or registrations to receive, store, dispense
and return controlled substances as required by local law? ………………………………………………………
The storage facility for controlled substances is securely constructed with restricted access toprevent theft or diversion? ……………………………………………………………………………………………………….
Radio labeled IP capability? …………………………………………………………………………………………………...
Does your site have the capability to destroy IP on site for controlled substances?
10. SOURCE DOCUMENTATION/CRFS/SITE MONITORING
Source documents: Are site source documents
Paper
Electronic
Please list any access limitations/requirements for the electronic medical records

Yes
Yes

NoNo

Yes

No

Yes
Yes

No
No

N/AN/AYes
Yes

No
No

N/AN/AYes

No

N/AYes
Yes
Yes

No
No
No

N/A
N/A
N/A

Both

Management of a user with ID and password, CRA can be referred to by the subject registered by the clinical trial concerned,
Implementation of training about an electronic medical record.

Will monitors have access toPhone

Copy machines

Fax

CRFs
What electronic data systems has your staff used for clinical trials?
Other, please list

InformInternet access

Medidata Rave

OracleTao,Data track,Viedoc,E-DMS,eClinicalBase,DDworks,MARVIN,BIOCLINICA,Open Clinica,Ecaselink

www.transceleratebiopharmainc.com-4 of 5-Site Profile Form v 3.2: February 19, 2014

Please provide any additional information not captured elsewhere on this form, that you feel is important that we should know
about your site. Please reference section number if applicable:

www.transceleratebiopharmainc.com-5 of 5-Site Profile Form v 3.2: February 19, 2014