Current information

The Guide on organizing the activities of Ethics Committees, developed by the State Expert Center, is now available in English

In order to improve the accessibility and transparency of regulatory requirements for conducting clinical trials in Ukraine for existing and potential foreign sponsors / applicants, the website of the State Enterprise “State Expert Center” of the MoH of Ukraine has published an English translation of the guideline “Guideline: General principles of organizing the activities of ethics committees at healthcare institutions where clinical trials of medicinal products are conducted”, made by Synergy Group Ukraine LLC.
“Guideline On general principles for organizing the activities of ethics committees in medical and preventive institutions, involved in drug clinical trials conduct (recommendations for experts)”

The guide was developed taking into account international documents regulating the work of ethics committees: the World Medical Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”, the International Ethical Guidelines for Biomedical Research Involving Human Subjects developed by the Council for International Organizations of Medical Sciences (CIOMS), ICH GCP, Directive 2001/20/EC, REGULATION (EU) No. 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014, as well as the requirements of the Law of Ukraine “On Medicinal Products” and MoH of Ukraine Order No. 690 of 23.09.2009 “On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees”, as amended.

ON THE INVOLVEMENT OF SMO (SITE MANAGEMENT ORGANIZATIONS) IN CONDUCTING CLINICAL TRIALS

Worldwide, specialized organizations, the so-called Site Management Organizations (hereinafter – SMOs), are increasingly involved in conducting clinical trials. These organizations may be engaged by a sponsor or a contract research organization, as well as by a healthcare institution (hereinafter – HCI). SMOs usually take on auxiliary functions (such as site selection and coordination of their work, patient recruitment, technical support, monitoring and risk management, staff training, logistics of clinical trial procedures, arranging transportation services, etc.) that improve the management and administration of the clinical trial and have a positive effect on its conduct.

Because the involvement of SMOs is actively developing in Ukraine as well, and there is already experience of successfully involving them in clinical trials, persons involved in conducting clinical trials have begun to raise questions about streamlining their work. Accordingly, the State Expert Center of the Ministry of Health of Ukraine brings the following to the attention of all interested persons involved in conducting clinical trials.

The basic requirement for engaging any persons (including additional organizations such as “SMO”) in organizing the conduct of a clinical trial is set out in para. 9.1 of Section IX of MoH of Ukraine Order No. 690 of 23.09.2009 “On approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees”. This paragraph provides the following: “A clinical trial may begin at each specific trial site … provided that contractual relations are formalized between all legal entities and individuals involved in conducting the clinical trial, and after a contract on life and health insurance of the patient (volunteer) is concluded in the manner prescribed by legislation.”.

Thus, the current regulatory framework does not contain a prohibition on such involvement. At the same time, the following must be taken into account:

1. The engagement of an SMO must be properly documented in contractual documents. The sponsor/applicant, the principal investigator and the management of the healthcare facility must all define, establish and allocate all responsibilities and functions related to the clinical trial before it begins.
2. It is necessary to clearly distinguish SMOs from other persons involved in conducting clinical trials, to whom certain requirements and restrictions under current legislation apply, in particular from contract research organizations (CROs), whose engagement is directly regulated (as regards the procedure for notifying of the engagement of such organizations, the procedure by which the sponsor delegates its authority to them, etc.).
3. The legal status and regulation of a person involved in conducting a clinical trial is determined not by the name of that person but by the functions it performs. Thus, if an organization, although named SMO, in fact performs the functions and has the powers of a CRO, then the legislative requirements for CROs will apply to it.

The State Expert Center of the Ministry of Health of Ukraine will continue to contribute to improving the system of clinical trials of medicinal products in Ukraine in accordance with modern international requirements.

Training seminars planned by the Center