List of documents for consideration

The dossier documents must be sent online to the Local Bioethics Committee's email address lbk_zkmu@mail.ru and also submitted in a file folder with dividers. A detailed list of documents (dates and version numbers) should be attached to the dossier in paper form (1 copy).

1. Application addressed to the Chair of the LBC (Form A-1)
2. Research application (Form A-2)
3. Informed consent form with information for participants in both the state and Russian languages (Form A-3).

• For clinical trials of medicinal products, an "Information sheet for the patient participating in the clinical trial of the medicinal product" is required.
• In the case of research with databases, a document confirming the approval of the supervisor for obtaining data is sufficient. For surveys, participant information is provided at the beginning of the survey, with participants agreeing to participate by answering.

4. Research protocol (Summary) (Form A-4)
5. Scales, questionnaires, algorithms, or other materials used in the research should be provided in the original language.

1. Investigator's brochure related to clinical trials.

7. Current Curriculum Vitae (CV) of the researchers, signed and dated. Copies of GCP certificates for the principal investigators (mandatory) and research team members (if available). GLP certificate if available.
8. List of research team members with their current qualification details. For principal investigators, documents confirming their medical specialization relevant to the research and at least five years of experience in clinical research.

1. Autobiography of the investigator, scientific supervisor, and scientific consultant.

10. When submitting a request for reconsideration (in the case of changes to the research plan and protocol), attach the documents of the new version and indicate that the request is a repeat (attach the previous version of the LBC decision). For ongoing research, interim reports must be submitted annually according to the form; for completed research, a final report must be submitted according to the form. For interim and final reports, attach the previous versions of the LBC decision. Refer to the forms for reports in the annexes.
11. The application for interim and final reports should be filled out according to the requirements (Annex 7).
12. When conducting research on laboratory animals, the relevant documentation forms must be completed (Annex 3).