Article 7. Clinical trials of medicines.
Article 8. Protection of patient (volunteer) rights.
of conducting clinical trials and expertizing clinical trial materials.
VIII. Evaluation of ethical, moral, and legal aspects of a clinical trial.
8.1 Evaluation of ethical, moral, and legal aspects of the clinical trial is carried out by the committees on ethics at the medical organizations, where the clinical trial is being conducted.
8.4 For evaluating the ethical aspects of a clinical trial, the Applicant submits such documents to the ethics committee at medical organization:
8.4.5 A copy of the conclusion of the Centre approved by the MoH of Ukraine (if applicable).