The procedure for submitting an application for examination to the Local Ethics Commission

1. The procedure for submitting an application for an examination in the LC on ethics issues
2. Application for ethical examination in the LEC for conducting a clinical trial of a medicinal product
3. Researcher's brochure on medical devices and medical equipment
4. Dossier of the investigated medicinal product
5. Application for the ethical examination of the LEC for the examination of clinical research materials of medical devices and medical equipment
6. Notification of an adverse event related to the use of a medical device and medical equipment
7. Informed consent to participate in the study
8. Protocol of clinical examination of medical devices and medical equipment
9. Clinical trial protocol
10. Researcher's resume
11. Reporting of a serious adverse reaction to drugs during a clinical trial
12. Technical file for medical devices and medical equipment (except for medical devices and medical equipment for in vitro diagnostics)
13. Application for ethical examination of LEC JSC «SCPCS»
14. Form of the report on the clinical study of medical devices and medical equipment
15. Order 142 On Preclinical and Clinical research
16. Cover letter formCover letter form