Facility Details for Yamaguchi University Hospital

FACILITY NAME & ADDRESS
Facility Name
Yamaguchi University
Hospital

FACILITY CONTACTS
Primary
FPM?
Yes

Facility Type
Hospital or Medical Center

Facility Address
1-1-1 Minami-kogushi, Ube,
Yamaguchi, Japan, 755-8505

Name

Email Address

Roles

Kondo, Tomoko

sktomoko@yamaguchi-u.ac.jp

Facility Profile Manager

THERAPEUTIC AREAS & PATIENT POPULATION
Therapeutic Area(s)Therapeutic Area
Allergy
Bacterial Infections and Mycoses
Bacterial Infections and Mycoses
Bacterial Infections and Mycoses
Bacterial Infections and Mycoses
Bacterial Infections and Mycoses
Bone
Bone
Cardiovascular Diseases
Cardiovascular Diseases
Cardiovascular Diseases
Cardiovascular Diseases
Cardiovascular Diseases
Cardiovascular Diseases
Cardiovascular Diseases
Chemically-induced Disorders
Chemically-induced Disorders
Chemically-induced Disorders
Congenital, Hereditary, and Neonatal Diseases andAbnormalities
Congenital, Hereditary, and Neonatal Diseases andAbnormalities
Congenital, Hereditary, and Neonatal Diseases andAbnormalities
Congenital, Hereditary, and Neonatal Diseases andAbnormalities
DeviceDigestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Digestive System Diseases
Disorders of Environmental Origin
Disorders of Environmental Origin
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases

Sub-Therapeutic Area
Allergy
Bacterial Infections
Central Nervous System Infections
Infection
Mycoses
ZoonosesBone
Osteoporosis
Cardiovascular Abnormalities
Cardiovascular Infections
Heart Diseases
Kidney Diseases
MetabolicPregnancy Complications, Cardiovascular
Vascular Diseases
Drug-Related Side Effects and Adverse Reactions
Poisoning
Substance-Related Disorders
Congenital Abnormalities
Fetal Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
DeviceBiliary Tract Diseases
Digestive System Abnormalities
Digestive System Fistula
Digestive System Neoplasms
Gastrointestinal Diseases
Inflammatory Bowel Disease
Liver Diseases
Pancreatic Diseases
Peritoneal Diseases
Environmental Illness
Preconception Injuries
Adrenal Gland Diseases
Bone Diseases, Endocrine
Diabetes Mellitus
Dwarfism
Endocrine Gland Neoplasms
Female Athlete Triad Syndrome
Gonadal Disorders
Parathyroid Diseases

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Facility Details for Yamaguchi University Hospital
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Endocrine System Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Eye Diseases
Female Urogenital Diseases and Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Fertility
Hemic and Lymphatic Diseases
Hemic and Lymphatic Diseases
Hemic and Lymphatic Diseases
Hemic and Lymphatic Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Immune System Diseases
Infectious Diseases
Inflammation
Internal Medicine
Male Urogenital Diseases
Male Urogenital Diseases
Male Urogenital Diseases
Male Urogenital Diseases
Male Urogenital Diseases
Male Urogenital Diseases
Mental disorders
Mental disorders
Mental disorders

Pituitary Diseases
Polyendocrinopathies, Autoimmune
Thyroid Diseases
Tuberculosis, Endocrine
Asthenopia
Cogan Syndrome
Conjunctival Diseases
Corneal Diseases
Eye Abnormalities
Eye Diseases, Hereditary
Eye Hemorrhage
Eye Infections
Eye Injuries
Eye Manifestations
Eye Neoplasms
Eyelid Diseases
Lacrimal Apparatus Diseases
Lens Diseases
Ocular Hypertension
Ocular Hypotension
Ocular Motility Disorders
Optic Nerve Diseases
Orbital Diseases
Pupil Disorders
Refractive Errors
Retinal Diseases
Scleral Diseases
Uveal Diseases
Vision Disorders
Vitreous Detachment
Female Urogenital Diseases
Pregnancy Complications
Fertility
AnemiaHematologic Diseases
Hemophilia
Lymphatic Diseases
Autoimmune Diseases
Erythroblastosis, Fetal
Glomerulonephritis, Membranoproliferative
Graft vs Host Disease
Hypersensitivity
Immune Reconstitution Inflammatory Syndrome
Immunologic Deficiency Syndromes
Immunoproliferative Disorders
Purpura, Thrombocytopenic
Transfusion Reaction
Infectious Diseases
Inflammation
Internal Medicine
Genital Diseases, Male
Pelvic Floor Disorders
Tuberculosis, Urogenital
Urogenital Abnormalities
Urogenital Neoplasms
Urologic Diseases
Anxiety Disorders
Bipolar and Related Disorders
Disruptive, Impulse Control, and Conduct Disorders

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Facility Details for Yamaguchi University Hospital
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Mental disorders
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Neoplasms
Nephrology
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases
Nervous System Diseases

Dissociative Disorders
Elimination Disorders
Feeding and Eating Disorders
Mood Disorders
Motor Disorders
Neurocognitive Disorders
Neurodevelopmental Disorders
Neurotic Disorders
Paraphilic Disorders
Personality Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Sexual Dysfunctions, PsychologicalSleep Wake Disorders
Somatoform Disorders
Substance-Related Disorders
Trauma and Stressor Related Disorders
Arthritis
Bone Diseases
Cartilage Diseases
Fasciitis
Foot Deformities
Foot Diseases
Hand Deformities
Jaw Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Rheumatic Diseases
Cysts
Hamartoma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Experimental
Neoplasms, Hormone-Dependent
Neoplasms, Multiple Primary
Neoplasms, Post-Traumatic
Neoplasms, Radiation-Induced
Neoplasms, Second Primary
Neoplastic Processes
Neoplastic Syndromes, Hereditary
Paraneoplastic Syndromes
Precancerous Conditions
Pregnancy Complications, Neoplastic
Nephrology
Autoimmune Diseases of the Nervous System
Autonomic Nervous System Diseases
Central Nervous System Diseases
Chronobiology Disorders
Cranial Nerve Diseases
Demyelinating Diseases
Nervous System Malformations
Nervous System Neoplasms
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neurologic Manifestations
Neuromuscular Diseases
Neurotoxicity Syndromes
Restless Legs Syndrome
Sleep Wake Disorders

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Facility Details for Yamaguchi University Hospital
Nervous System Diseases
Neuroscience
Nutritional and Metabolic Diseases
Nutritional and Metabolic Diseases
Ob-GynOccupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Occupational Diseases
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Oncology
Orthopedics
Otorhinolaryngologic Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Diseases
Pain
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases

Trauma, Nervous System
Neuroscience
Metabolic Diseases
Nutrition Disorders
Ob-GynAgricultural Workers' Diseases
Asthma, Occupational
Bird Fancier's Lung
Burnout, Professional
Dermatitis, Occupational
Hand-Arm Vibration Syndrome
High Pressure Neurological Syndrome
Inert Gas Narcosis
Laboratory Infection
Persian Gulf Syndrome
Pneumoconiosis
Sleep Disorders, Circadian Rhythm
Bladder
Brain
BreastCarcinoma
Central Nervous System
CervicalColorectal
Esophagael
Gastric
Gastrointestinal
Genitourinary
Head and Neck
Hematologic Malignancies
Hepatocellular Carcinoma
Leukemia
Lung
Lymphoma
Melanoma
Multiple Myeloma
OvarianPediatrics
Prostate
Radiation Oncology
Renal
Sarcoma
Skin
UterineOrthopedics
Ciliary Motility Disorders
Ear Diseases
Laryngeal Diseases
Nose Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pain
Central Nervous System Parasitic Infections
Coinfection
Eye Infections, Parasitic
Helminthiasis
Intestinal Diseases, Parasitic
Liver Diseases, Parasitic
Lung Diseases, Parasitic

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Facility Details for Yamaguchi University Hospital
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Parasitic Diseases
Pathological Conditions, Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Pediatrics
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Respiratory Tract Diseases
Skin and Connective Tissue Diseases
Skin and Connective Tissue Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Stomatognathic Diseases
Vaccines
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Virus Diseases
Women's Health
Wounds and Injuries
Wounds and Injuries

Mesomycetozoea Infections
Opportunistic Infections
Parasitemia
Parasitic Diseases, Animal
Pregnancy Complications, Parasitic
Protozoan Infections
Skin Diseases, Parasitic
ZoonosesMorphological and Microscopic Findings
Pathologic Processes
Pathological Conditions, Anatomical
Signs and Symptoms
Pediatrics
Bronchial Diseases
Ciliary Motility Disorders
Granuloma, Respiratory Tract
Laryngeal Diseases
Lung Diseases
Nose Diseases
Pleural Diseases
Respiration Disorders
Respiratory Hypersensitivity
Respiratory System Abnormalities
Respiratory Tract Fistula
Respiratory Tract Infections
Respiratory Tract Neoplasms
Thoracic Diseases
Tracheal Diseases
Connective Tissue Diseases
Skin Diseases
Ankyloglossia
Jaw Diseases
Mouth Diseases
Pharyngeal Diseases
Stomatognathic System Abnormalities
Temporomandibular Joint Disorders
Tooth Diseases
Vaccines
Arbovirus Infections
Bronchiolitis, Viral
Central Nervous System Viral Diseases
Coinfection
DNA Virus Infections
Encephalitis, Viral
Eye Infections, Viral
Fatigue Syndrome, Chronic
Hepatitis, Viral, Human
Opportunistic Infections
Pneumonia, Viral
RNA Virus Infections
Sexually Transmitted Diseases
Skin Diseases, Viral
Slow Virus Diseases
Tumor Virus Infections
Viremia
Zoonoses
Women's Health
Abdominal Injuries
Amputation, Traumatic

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Facility Details for Yamaguchi University Hospital
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries
Wounds and Injuries

Other Areas of Expertise

Arm Injuries
Asphyxia
Athletic Injuries
Back Injuries
Barotrauma
Battered Child Syndrome
Birth Injuries
Bites and Stings
Burns
Cold Injury
Contrecoup Injury
Crush Injuries
Drowning
Electric Injuries
Esophageal Perforation
Extravasation of Diagnostic and Therapeutic Materials
Foreign Bodies
Fractures, Bone
Fractures, Cartilage
Frostbite
Hand Injuries
Heat Stress Disorders
Hip Injuries
Joint Dislocations
Lacerations
Leg Injuries
Microtrauma, PhysicalMultiple Trauma
Nasal Septal Perforation
Neck Injuries
Occupational Injuries
Radiation Injuries
Retropneumoperitoneum
RuptureSelf Mutilation
Shock, Traumatic
Shoulder Injuries
Soft Tissue Injuries
Spinal Cord Injuries
Sprains and Strains
Surgical Wound
Tendon Injuries
Thoracic Injuries
Tooth Injuries
Trauma, Nervous System
Tympanic Membrane Perforation
Vascular System Injuries
War-Related Injuries
Wounds, Nonpenetrating
Wounds, Penetrating

Study Phase Capabilities

Phase I; Phase II; Phase III; Phase IV

Other Facility Details

Do 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
the same investigator who sees subjects at the primary site location.

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Facility Details for Yamaguchi University Hospital
What study types does your Facility have experience with?
Is your Facility affiliated with a government agency or part of a government funded
health service?

Patient Population

Patient Population Demographics

Industry; Investigator Initiated;
Academic
Yes

Pediatrics - Less than or equal to17; Adults - Ages 18-64; Geriatrics- Greater than or equal to 65

Patient Population Comments
IRB/ERB/ETHICS COMMITTEE
General Questions

What is the average time (in days) to start a study once you have received theregulatory package?
Does your facility perform IRB/ERB/Ethics Committee submissions?
Does your facility have a dedicated department or group to perform IRB/ERB/Ethics
Committee submissions?
Department Contact Name
Department Contact Phone Number
Department Contact Email Address
Is 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?
Does your institution and/or local regulation mandate the distribution of safety reports[e.g., Development SafetyUpdate 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 your IRB/ERB/
Ethics Committee review and submission?
Other Steps Explain

OTHER REVIEW BOARDS

Does your facility have Other Review Boards that need to approve the study priorto IRB/ERB/Ethics Committee submission? For example, scientific, radiation safetycommittees, or others.

Local LabGreater than 120
Yes
Yes
Center for Clinical Research+81-836-22-2428
ychiken@yamaguchi-u.ac.jp
Yes
Local
Yes
No

No

Is your Facility using a Local Lab?

Yes

Lab Name

Yamaguchi University Hospital
Division of Laboratory

Local Lab: Yamaguchi University Hospital Division of Laboratory
Lab Contact First NameLab Contact Last Name
Address

1-1-1, Minami-kogushi, Ube,
Yamaguchi, Japan, 755-8505+81-836-22-2582

Phone Number
Fax Number
Email Address
Local Lab Accreditation
Other Local Lab Accreditation

CAP; ISO; Others
Japanese Association of Medical
Technologists and JapaneseCommittee for Clinical Laboratory
Standards

CONSENT & TRAINING
Consent

Does your Facility have a written SOP/Policy/Procedure for: Informed Consent?
Does your Facility have a written SOP/Policy/Procedure for: Minor Assent for
Pediatric Populations?
Does your Facility have a written SOP/Policy/Procedure for: Other Vulnerable
Populations?

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Yes
Yes
Yes

Facility Details for Yamaguchi University HospitalWill your Facility require language translations for consents?
Select the required languages
If located in the US, has your Facility used or are you able to use the informed
consent short form?

Yes
Japanese
Not Applicable

Does your Facility have a training program for the research staff?
Does the course content include GCP?
Does your Facility use an external program to conduct research training?
Please provide program course name.

Yes
Yes
Yes
Training in clinicalreserch(including GCP) sponsored
by MEXT, Training in clinicalreserch(including GCP) sponsoredby Japanese Society of Hospital
Pharmacists, Training in clinicalreserch(including GCP) sponsoredby MHLW, PMDA GCP Training
courseYes

Training

Do you have a process or program in place to retrain research staff when a protocol
is amended?
Does the study staff that prepares or transports dangerous goods have trainingthat meets the IATA International Air Transport Association (US) or other countries
hazardous training requirements for shipping dangerous goods?

FACILITY & EQUIPMENT
Facility Capabilities

Yes

Can your Facility support patient visits on weekends?
Can your Facility support in-patient admissions for research studies?
Does your study staff have sufficient English knowledge to understandcommunications in English?
Does your Facility have access to translators and translation support for trial conduct(e.g. consent, trial specific instruction)?
Does the Facility have storage space for Study-Related materials (e.g. Lab Kits,
Patient Materials, etc.)?
Does your Facility have the ability to collect and store PK/PD specimens?
Does your Facility have the ability to collect PK/PD samples beyond normal businesshours?
Does your Facility typically allow the collection of Pharmacogenomic (PGX) samples
for research purposes?

Yes
Yes
No

Identify the Diagnostic Equipment available at or near the Facility to support
Research studies?

Computerized Tomography Scan;
Dual-Energy X-ray Absorptiometryor Bone Densitometry; Magnetic
Resonance Imaging; Fluoroscopy;
X-Radiation; Magnetic ResonanceAngiography; Magnetic
Resonance Spectroscopy;
Mammography; Nuclear
Medicine (e.g.Bone scan,Thyroid
scan,Thallium cardiac stress test);
Electrocardiogram

Equipment

General Equipment

No
Yes
Yes
Yes
Yes

Does your Facility have an SOP or process that ensures routine calibration andmaintenance 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

Identify the equipment available at the Facility to support Research studies?

Refrigerated Centrifuge;Centrifuge; Refrigerator (2 to 8
Degrees C); Freezer (-20 to -30
Degrees C); Freezer (-70 to -80
Degrees C)

Equipment Available At The Facility To Support Research Studies

Equipment Capabilities: Refrigerator (2 to 8 Degrees C)
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Facility Details for Yamaguchi University Hospital
Do you have the ability to generate a temperature monitoring log for this equipment?
Does this equipment provide Min/Max Temperature Monitoring?
How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?
Does this equipment have a temperature alarm?
Do you have an SOP which supports calibration of this equipment?

Yes
Yes
HourlyDo you have the ability to generate a temperature monitoring log for this equipment?
Does this equipment provide Min/Max Temperature Monitoring?
How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?
Does this equipment have a temperature alarm?
Do you have an SOP which supports calibration of this equipment?

Yes
Yes
HourlyDo you have the ability to generate a temperature monitoring log for this equipment?
Does this equipment provide Min/Max Temperature Monitoring?
How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?
Does this equipment have a temperature alarm?
Do you have an SOP which supports calibration of this equipment?

Yes
Yes
HourlyDoes your Facility have computers which are dedicated to research studies?
What type of computer operating system(s) does your institution use to support
studies?
What type of internet access does your Facility have?
Does your Facility limit or prohibit access and use of external web-based tools orsites for clinical research? (e.g. web portals to submit documents to sponsors or
CROs)
Does the Facility have access to local IT support?

Yes
Windows (Windows XP, Windows
7, Windows 8, etc.)
Cable or DSL; Wi-Fi
No

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

Equipment Capabilities: Refrigerator (-70 to -80 Degrees C)

Computer Capabilities

INVESTIGATIONAL PRODUCT & CONTROLLED SUBSTANCES
Investigational Product Shipping Details
IP Recipient Name
Address
Email Address:
Phone Number:
Fax Number:

Investigational Product Storage Location
IP Storage Location Name

Yes
Yes
Yes

Yes
Yes
Yes

Yes
Yes
Yes

Yes

Yamaguchi University Hospital
Department of Pharmacy
1-1-1, Minami-kogushi, Ube,
Yamaguchi, Japan, 755-8505
di-info@yamaguchi-u.ac.jp+81-836-22-2668

Yamaguchi University Hospital
Department of Pharmacy
1-1-1, Minami-kogushi, Ube,
Yamaguchi, Japan, 755-8505
di-info@yamaguchi-u.ac.jp+81-836-22-2668

Address
Email Address:
Phone Number:
Fax Number:

Investigational Product Storage Equipment

Identify the Investigational Product Storage Equipment at your Facility

Equipment Capabilities: Refrigerator (2 to 8 Degrees C)

Do you have the ability to generate a temperature monitoring log for this equipment?
Does this equipment provide Min/Max Temperature Monitoring?
How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?
Does this equipment have a temperature alarm?
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Refrigerator (2 to 8 Degrees C);
Freezer (-20 to -30 Degrees C)
Yes
Yes
Daily
Yes
Yes

Facility Details for Yamaguchi University Hospital
Do you have an SOP which supports calibration of this equipment?

Yes

Do you have the ability to generate a temperature monitoring log for this equipment?
Does this equipment have Min/Max Temperature Monitoring?
How frequently can temperature measurement occur? Check the most frequent
measurement your equipment can support.
Does this equipment have back-up power?
Does this equipment have a temperature alarm?
Do you have an SOP which supports calibration of this equipment?

Yes
Yes
Daily

Is the Investigational Product Storage Room secured with controlled access?
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?
Does the Investigational Product Storage Room have back-up power?
Does the Investigational Product Storage Room have a temperature alarm?
Do you have an SOP which supports calibration of the temperature monitoring
equipment?
Does your Facility have the ability to manage on-site or off-site destruction of
Investigational Product?
Does your Facility have a written SOP/Policy/Procedure for destruction of
Investigational Product?
Do you provide your Satellite Site(s) with a dedicated inventory of Investigational
Product?
Does your Facility have a written SOP/Policy/Procedure to ensure that Investigational
Product is appropriately maintained during transportation to Satellite Site(s)?
Describe additional Investigational Product Storage & Handling Capabilities

Yes
Yes

Identify the Investigational Product preparation capabilities at your Facility

Extemporaneous Preparation;
Vertical laminar flow hood (chemo/
hazardous drugs)
Yes
Yes

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

Investigational Product Storage And Handling

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

Controlled Substances

Yes
Yes
Yes

Yes
Yes
Yes
Yes
Yes
Yes
Not Applicable
Not Applicable

Does the Facility have the required licenses or registrations to receive, store,
dispense and return controlled substances as required by local law?
Is the storage area for controlled substances securely constructed with restricted
access in accordance with local law?
Does the Facility have the ability to handle radio-labelled Investigational Product?
Does your Facility have the ability to manage on-site or off-site destruction ofcontrolled substances when appropriate?

Yes

Document TypeNo Records

Description

Attachments

Document Name

SOURCE DOCUMENTATION
Source Documents

Yes
Yes
Yes

What type of source documents will be used?
Does your Facility have secure storage for patient records?
Does your Facility have patient record archiving on-site?
Provide Location name and address of any offsite archives

Paper; Electronic
Yes
Yes

Do you have Electronic Health Records (EHR)/ Electronic Medical Records (EMR)?
What EMR/EHR system do you use?
For Facilities with satellite sites, where is the monitor required to access source
documents?
Please list any access limitations/requirements for the Electronic Medical Records.

Yes
In-house system

Electronic Medical Records (EMR)/Electronic Health Records (EHR)

Monitoring

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Facility Details for Yamaguchi University Hospital
Check all equipment that will be available to Monitors:
What Electronic Data Capture (EDC) systems has your staff used for clinical trials?

Phone; Fax; Copy Machines;
Internet Access
Oracle Inform; Medidata Rave;
Oracle RDC Remote Data Capture

ADDITIONAL LOCATIONS
Additional Locations

Add any addresses you wish to be available in the Study Site Profile. These addresses will be available for selection in thefollowing sections of the Study Site Profile Additional Study Locations - These addresses can be added to your FDA Form 1572, if applicable.
Location Name Contact Name Address
Phone
Fax Number
E-mailAddress
Number
No Records

ADDITIONAL INFORMATION & ATTACHMENTS
Additional Information

Please provide additional information not captured in other sections of the Facility Profile that you feel is important forSponsors to know about your Facility. Please reference the section name if applicable.

Facility Attachments
Document TypeNo Records

Document Name

ORGANIZATION AFFILIATIONS
Organization Affiliations

Document Description

The Organization (s) that requested Affiliation with your Facility/Department are listed below with Affiliation Status
Organization Name and Address
Organization Affiliation
Organization Affiliation
Status DateType
StatusNo Records

Facility Profile Export generated on Fri, 05-Jun-2020 17:41:21 GMT+09:00
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