Cancer Diseases Hospital

Clinical Trial Experience

Therapeutic area interests:

Cancer

Infectious disease

Institution has received grant(s) from:

National Funder(s)

International Funder(s)

Sponsors for previous clinical trials include:

Academic

Government

Industry

Investigator-initiated

Previous clinical trials conducted:

Behavioral

Diagnostic

Drug – biologic

Drug – small molecule

Epidemiological

Observational

Surgical

Vaccine

Study phase capabilities:

Phase I

Phase II

Phase III

Phase IV

Pediatric research capabilities:

No

Institution Regulatory/Research Ethics Committees

Frequency of meetings: Twice monthly

Application turnaround time (IRB/IEC): 1-2 weeks

Average time from receipt of final protocol to review and approval of study by all relevant committees: 3-4 weeks

Additional compliance:

IRB/IEC in compliance with IC E6(R2) in terms of composition, functions, and operations guidelines

Institution and/or local regulation mandates the distribution of study safety reports to IRB/IEC

Institution Staffing Resources

Institution Diagnostic Capabilities

Institution has personnel capable of performing diagnostic biopsies

Biopsies performed on-site:

Core needle biopsy

Endoscopic biopsy

Fine needle aspirate

Liquid biopsy

Sentinel lymph node biopsy

Skin biopsy

Surgical biopsy

Laboratory basics:

Institution has a laboratory on site

Institution sends diagnostic samples to external laboratory

Institution’s laboratory has been inspected or audited

Laboratory accreditations:

None

Tests performed on-site:

Complete blood count (CBC) with differential

Comprehensive metabolic-chemistry panel (CMP)

Routine urinalysis

Antibody tests

Antigen tests

Antimicrobial susceptibility and sensitivity

Bacterial smear and culture

Flow cytometry

Fluorescent in situ hybridization (FISH)

Fungal culture

Genetic testing

Histology

Immunohistochemistry (IHC)

Laboratory-developed tests (LDTs)

Microscopy

Ova and parasite (O&P) test

PCR and/or RT-PCR

Other nucleic acid amplification tests (NAATs)

Viral culture

Viral load

Imaging capabilities:

Computed tomography (CT)

Magnetic resonance imaging (MRI)

Positron emission tomography (PET)

Nuclear imaging

Ultrasound

X-ray

Pediatric imaging

Institution Research Systems, Recordkeeping, and Data Management

Institution adheres to informed consent processes compliant with ICH E6(R2)

Institution follows ICH E6(R2) for collection and storage of source documentation for paper and/or electronic records

Institution stores patient records/source documents (paper/electronic) in a secured, limited access location during and after the trial

For source documents collected via electronic data capture, institution has a validated system and site procedures that follow ICH E6(R2) 5.5 guidelines

Institution has process in place for proper storage, archiving, and retrieval of essential study document per ICH 8.1

Institution study monitors have full access to source documents or certified copies of source documents (if electronic) if direct access can’t be obtained

Institution has a finance administration team

Institution undergoes routine financial audits

Institution Pharmacy

Pharmacy on site

Pharmacy has secure, limited access storage area with daily temperature monitoring and backup generator

Pharmacy has standard processes in place to ensure proper receipt, handling, and storage of investigational study drug/vaccine and comparators

Pharmacy has standard processes in place to ensure proper dispensing

Pharmacy has standard processes in place to ensure proper labeling that maintains the study blind

Pharmacy has standard processes in place to ensure proper drug/vaccine accountability, retrieval, and return or destruction of unused product

Institution has a secure, limited-access investigational drug/vaccine storage area with daily temperature monitoring

Institution’s pharmacy has a backup generator sufficient to run necessary equipment, refrigerators, freezers, etc.

Institution Equipment

Protocol for managing anaphylactic shock

Institution has a blood bank

Institution carries out blood transfusions for patients that need it

Functioning IV infusion pumps

Functioning basic life support equipment (crash cart)

Functioning electrocardiogram (EKG)

Availability of banked blood at institution:

Always available

Occasionally available

Rarely available

Institution performs the following routine blood screening tests on banked blood:

HIV

HBV

HCV

HPV

HTLVI

HTLVII

Syphilis

Additional information:

Institution’s equipment is calibrated and maintained per manufacturer’s guidelines

Institution’s equipment calibration and maintenance is documented

Institution’s laboratory has a secure, limited access biological specimen storage area with daily temperature monitoring

Institution’s laboratory has a backup power source, with alarm, sufficient to run necessary equipment, refrigerators, freezers, etc.

Institution maintains and uses a diagnostic imaging protocol manual

Laboratory maintains and uses a laboratory protocol manual

Laboratory maintains and uses a laboratory protocol manual

Institution Cancer Treatment Capabilities and Equipment

Treats cancer patients

Performs surgical excisions

Administers chemotherapy

Uses radiation therapy

Radiotherapy machines on site:

Linear accelerator

Cobalt 60

Brachytherapy machine