Annex 8 to the Item 4
Annex 8 to item 4.1.16of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials
Card of Certification of clinical site of the State Pharmacological Center MoH Ukraine
1. Name, address, telephone number of healthcare setting, to which clinical site is subordinated. Director's full name, telephone number, fax number, e-mail.
1.1. Name, addressand telephone number of clinical trial site. Director'sfullname, telephone number, fax number, e-mail.
2. Main research and clinical directions of activities:
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3. Staff:
Total number of employees(full-time staff of clinical site):
Including scientific workers:
doctors of sciences
candidates of sciences
no degree
post-graduate students
physicians
4. Numberofpublicationswithinrecent 3 yearsbyemployees dealing with main directions of activities of the clinical trial site:
monographsarticles
summaries of reports
5. Bedcapacityanditscharacteristics (please specify types and quantity):
hospital bedsresuscitation
6. Out-patient clinic: yes no
total number of visits per shift:number of profile patients per shift :
day hospital: yes no
number of beds:
average number of patients per month:
7. Number of profile patients who can to be included in a trialsimultaneously:
hospitalout-patient clinic
8. Listofpharmacologicalgroupsofmedicinalproductstobetrialed:
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9. Listforlaboratory, clinicalandinstrumentaltestmethodsto be used in clinical trials (hereinafter- CT).
-Availabilityofauthorizationorcertificate for laboratory (date, №) where testing to be made in clinical trials:
10. Availability of equipment:
Availabilityofoperationalforeign-madeapparatuses (name, country, model, year of manufacture): / Metrological control (date of last control)Availability of operational domestic apparatuses (name, model, year of manufacture): / Metrological check-up (date of last check-up)
-Availability ofcomputersandothermeans of communication (quantity, model) and level of computer knowledge by employees:
11. Dataabout clinicaltrialsperformed at clinical site within recent 3 years:
- domestic medicinal products
Name of medicinal product/protocol of investigation / Test period / Authorization of CTby the State Pharmacological Center MoH Ukraine(SPhC MoH Ukraine) (№ and date of approval)-foreign-made medicinal products
Name of medicinal product/protocol of investigation / Test period / Authorization of CTby SPhC MoH Ukraine(№ and date of approval)- international multi-center CT
Name of medicinal product/protocol of investigation / Test period / Authorization of CTby SPhC MoH Ukraine(№ and date of approval)12. Availabilityoftechnicalcapabilities (place/facility) for keeping CT materials
13. Availabilityandnumberofmedical, scientificandsupportpersonneltrainedtoworkincompliancewithGCP (indicate site and date of training, availability of certificates)
14. Otherinformationaboutclinical site
15. AvailabilityoflocalEthicsCommittee (date of establishment, protocol №)
16. Dataaboutspecialists-investigatorsof clinical site (CV).
Director of health care setting ______
(signature)
Director of clinical site______
(signature)
Date ______
Seal
V.T. Chumak
Director,
State Pharmacological Center MoH Ukraine
All health-care settings which are a clinical trial site shall be specified and information about the appropriate agreement between health care setting and a clinical trial site shall be provided.