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:
- 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.
- 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.).
- 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.
