This section is summary of Section V of the Order of the Ministry of Health of Ukraine «Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees» No. 690 of September 23, 2009 with amendments (hereinafter – the Procedure).
Translation of Procedure is available at the web site of the Center, please note link below. Wording was modified and simplified, as well as titles were added to each clause for better readability. This work is neither legal document nor advice.
Terms
- CEB – Central Executive Body i.e. Ministry of Health of Ukraine
- Center – State Expert Center
- Health facility – Health Care Setting (HCS), Institution, Hospital
Summary of Section
5.1. Investigators expertise and employment
Investigators involved in a clinical trial:
- Should hold sufficient professional training, experience in treating patients with relevant indication
- To be aware of international requirements of Good Clinical Practice and clinical trials regulatory framework of Ukraine, and to participate in seminars organized by the Center
- To be an employee of Health Care Setting (HCS) where the clinical trial to be conducted (if the principal investigator/investigator is employee of a department of higher medical education institution the cooperation agreement between the institution and HCS is required)
- Investigators involved in clinical trials of Phase I and bioequivalence studies must have previous clinical trials experience with evidence of such qualification through curriculum vitae
5.2. Health Care Setting (hospital) resources
HCS may be involved in a clinical trial if:
- Ethics committee at HCS is composed and operational
- Adequate resources for providing trial subjects with an emergency medical care in case of medical complications during a clinical trial (for hospitals – resuscitation department or intensive care unit or intensive care intensive care ward(s) / bed(s)) are available
- Periodic metrological control of measuring instruments of HCS subdivisions (laboratory, functional diagnostics department) involved into clinical trials within the time frame and procedure as per established legislation are conducted
- Storage facilities for investigational medicinal products (according to storage conditions as per labeling of medicinal products or trial protocol) and study related documentations are established
- Sufficient number of study subjects as per study protocol is expected
- Source medical documentation is maintained according to established legislation and storage capacity (within archive premises) is no less than 15 years after completion of a clinical trial
5.3. Additional prerequisites for Phase I and for bioequivalence studies
HCS may be involved to a clinical trial of Phase I and to bioequivalence study of medicinal products if HCS meets the requirements stated in clause 5.2 of this section, and owns:
- Dedicated wards for subjects / healthy volunteers with ability for non-stop monitoring over their conditions
- Dedicated medical treatment / manipulation room, dining-room and bathroom for subjects
- Storage conditions for biological samples of clinical trials
5.4. Good Laboratory Practice compliance for pharmacokinetic labs
- The laboratory for pharmacokinetic studies involved into clinical trials should comply with requirements of Good Laboratory Practice (GLP)
5.5. Accreditation by Ministry of Health for bioequivalence studies
- HCS conducted bioequivalence studies of medicinal products should submit accreditation certificate issued by CEB to the Center (if available)
See also
External links
This document is based on translation of the Procedure published at web site of State Expert Center.
- Clinical research legislation (in English)