2.1.List of documents required for submission
- Cover letter (see Annex 3 to the Order of the MoH of Ukraine №690 from 23.09.2009, with amendments (further – Order of the MoH of Ukraine №690)).
- Application for getting a conclusion of the State Expert Center MoH Ukraine/approval of the ethics committee at health care settings (HCS) pertinent to conducting a clinical trial of a medicinal product. (see Annex 4 to the Order of the MoH of Ukraine №690).
- A brief summary (synopsis) of the protocol in Ukrainian.
- Investigator’s Brochure that should include information given in section 7 of Good Clinical Practice (GCP).
- A copy of the Center’s conclusion approved by the central executive body for health care (CEBHC) (if any).
- A letter of authorization from the sponsor with clearly specified granted powers if a clinical trial applicant differs from a sponsor.
- The draft informed consent and other written information to be provided to a healthy volunteer (patient) in Ukrainian or in an officially recognized language of international communication).
- Information on subject recruitment procedures (information and promotional materials to be used for subject recruitment to a clinical trial (if any)).
- Brief data on all ongoing clinical trials conducted with the use of the given investigational medicinal product (if any).
- An application from a responsible investigator according to form given in Annex 6 to the Order of the MoH of Ukraine №690.
- Information on HCS and clinical trial site (see Annex 7 to the Order of the MoH of Ukraine №690) valid at the time of submission of documents (materials).
- Information on responsible investigator/investigator (CV) should contain the following details: full name, year of birth, education, place of employment, position, a record of service, degree, scientific works, participation in clinical trials in the past (specify). Co-investigators’ CV should be submitted if doctors of different disciplines are involved in the clinical trial.
- Information which defines the terms of inducements or compensations provided to subjects for participation in a clinical trial (if envisaged by a clinical trial protocol), which may be submitted in a cover letter with reference to the relevant document foreseeing this.
- Sponsor’s/applicant’s instructions to responsible investigator/investigator concerning actions to be undertaken in the event which can be considered as an insured accident during the clinical trial in case of harm to subjects’ health and life.
- A copy of the certificate of the contract on healthy volunteer’s/patient’s life and health insurance.
Members of Ethics Committee maintain strict confidentiality of materials submitted for review and data obtained during the process of monitoring.,Order of the MoH of Ukraine dated 23.09.2009 No690 “About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees”, amended by Orders of the MoH Ukraine No523 dated 12.07.2012, No304 dated 06.05.2014, No966 dated 18.12.2014, No639 dated 01.10.2015.
2.2 Submission procedureClinical trial materials (one copy) should be submitted to Ethics Committee in paper and e-format. An application fully completed according to form given in Annex 3 to the Order of the MoH of Ukraine №690 should be submitted in e-format. During the assessment of ethical, moral and legal aspects of the clinical trial materials Ethics Committee may singly request (in writing) the applicant to submit additional materials and/or invite the applicant to the Committee’s meeting for giving additional clarification. The time necessary for submitting additional materials/clarifications should not exceed 30 calendar days. Ethics Committee informs the applicant about the decision taken in writing.
In case of negative results of the assessment of ethical, moral and legal aspects of the clinical trial the applicant may again submit the materials with grounds for their revision within 30 calendar days after getting the decision. These materials must be reviewed within 30 calendar days with giving the final assessment of ethical, moral and legal aspects of this clinical trial.
2.3.Terms of ethical reviewThe time necessary for assessing ethical, moral and legal aspects does not exceed 30 calendar days of getting an application by Ethics Committee (not including time necessary for preparation of the requested materials/clarification). In case of negative results of assessment of ethical, moral and legal aspects of the clinical trial the applicant may again submit the materials with grounds for their revision within 30 calendar days after getting the decision. These materials must be reviewed within 30 calendar days with giving the final assessment of ethical, moral and legal aspects of this clinical trial.