This section is summary of Section III 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
3.1. International ethical principles. Rights, safety and well-being
- Clinical trials should be conducted in accordance with international ethical principles assuring protection of the rights, safety and well-being of the trial subjects
- A clinical trial should be conducted only if the anticipated benefit justifies the risk
3.2. Purpose. Regulatory approval
- Clinical trials of medicinal products are conducted to establish or verify the efficacy and safety of medicinal product.
- Clinical trials may be conducted at health facility designated by the Ministry of Health upon its decision on conduction of clinical trials, which is based on positive conclusion issued by the State Expert Center.
3.3. Education and training
- All individuals involved into conduction of a clinical trial should have adequate education, professional training and experience to perform functions and duties related to the clinical trial.
3.4. Sponsor responsibility. Contract research organization (CRO)
- Sponsor is responsible for selecting investigators and health facilities. Requirements for investigators and health facilities are set out in Section V of the Procedure.
- A sponsor may transfer (delegate) some or all of its duties to a contract research organization. Even under such conditions responsibility for initiation and conducting of clinical trial and for the clinical trial data resides with the sponsor.
3.5. Commencement of trial
All clinical trials commenced after:
- decision taken by the MOH
- obtaining of EC protocol(s) with approval of the clinical trial at HCS where the trial will be conducted
- execution of patient’s (volunteer) life and health insurance as per established legislation
3.6. Confidentiality
- Maintaining the confidentiality of documents which might identify subject’s personality is mandatory requirement for protecting rights of the trial subject.
3.7. GCP compliance. Registry
- Planning, conducting and reporting of all clinical trials including bioequivalence studies, should be performed in compliance with requirements and principles of Good Clinical Practice (GCP).
- Each clinical trial of medicinal product should be listed on official site of CEB before enrollment of first trial subject. The clinical trial listing is for information purposes only and must not interfere with its conducting.
3.8. Narcotic drugs
- If the investigational medicinal product is a narcotic drug, psychotropic substance or precursor, its clinical trial should be conducted in compliance with requirements of the legislation pertaining to narcotic products, psychotropic substances or precursors.
3.9. Quality system
- System of specific procedures should be in place to ensure quality of all aspects of clinical trial.
3.10. Clinical trial data. Essential documents and Archives
- The clinical trial data should be recorded, processed and stored in a way that allows its accurate reporting, interpretation and verification.
- Essential documents of a clinical trial stored at the HCS/clinical trial site and with the sponsor are listed in Annex 1 to this Procedure, these documents should be stored in the archives for at least 15 years after completion of clinical trial.
3.11. Study Drug
- Manufacturing and storage of investigational medicinal product as well as its handling should be performed in accordance with the procedure established by law in compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
- Main labeling requirements of the investigational medicinal product are listed in Section VI of this Procedure. The investigational medicinal product must be used only in accordance with approved clinical trial protocol.
3.12. Regulatory Inspection
- At any stage of a clinical trial or after its completion the Center may conduct clinical audit of the clinical trial on Good Clinical Practice (GCP) compliance in accordance with section XIII of this Procedure.