Local Ethics Committee
At the Moscow Clinical Scientific Center named after A. S. Loginov (State Medical Institution MCSC named after A. S. Loginov DZM) the Ethics Committee has been established and is working on the basis of the Regulations on the Local Ethics Committee adopted by the Academic Council of the GBUZ MCSC MCSC named after A. S. Loginov DZM, Protocol No. 5 of April 18, 2014, and approved by the Director of the SBUZ MCSC named after A. S. Loginov DZM on April 24, 2014, and in accordance withStandards of Operating Procedures (SOP).
The Local Ethics Committee meets every penultimate Monday of the current month.
Documents for consideration by the EC are submitted two weeks before the meeting.
The Local Ethics Committee accepts the documents before the approval of the clinical trial by the Ministry of Health of the Russian Federation.
The sponsoring companies submit a full package of documents in Russian in printed form and in electronic form to the Secretary of the Ethics Committee Grach Natalia Olegovna, tel.: +7 910 468 62 31 (on disk and via email firstname.lastname@example.org).
The examination of the contract is carried out on the basis of:
1. Analysis of the package of documents for compliance with GOST R 52379-2005 " Good clinical practice»
2. The examination of the draft agreement provides for the participation of employees of the departments:
- economic department
- accounting department
- legal expertise
3. The term of examination of the draft contract is 1 month
The committee consists of highly qualified experts.
According to the recommendations of the bulletin of the Higher Attestation Commission (HAC) (No. 3 of 2002), all biomedical research conducted with the involvement of a person must be approved by the Ethics Committee.
To approve the topic of the dissertation, the Scientific Council of the MCSC named after A. S. Loginov must submit an opinion (approval) The Ethics Committee. The report is issued after an expert assessment of the relevant package of documents submitted to the Ethics Committee.
The MCSC MCSC named after A. S. Loginov considers and gives an ethical opinion for dissertations and scientific works that are carried out on the basis of the SBUZ MCSC named after A. S. Loginov DZM. To obtain a conclusion, the applicant collects the documents from the list, and in the folder passes to the secretary of the LEK.
Documents required for conducting an ethical review of clinical dissertation research.
Signed by the applicant and dated application addressed to the Chairman of the Ethics Committee. The application should include the full name of the study, a list of submitted documents, and contact details for clarification of any questions raised by the Committee. The application must be filled in with your own hand.
An extended abstract to the planned research (signed by the performer and the supervisor), which sets out the goals, objectives, materials and methods of the research, justification of scientific novelty and expediency, and expected results.
Protocol (plan, scheme) of the study.
A list of clinical centers (departments, departments) where the study is planned to be conducted, indicating their addresses.
Basic information about the test product or method (including instructions for the use of the test products).
Form of individual patient registration card.
Professional autobiography of a researcher.
The title page (on the folder-folder).
- Minutes of the meeting of the department (laboratory), where the topic of the dissertation work was discussed, signed by the head of the department (laboratory).
Please note that if necessary, the Ethics Committee may request the reviewer's opinion on the research work.
All documents are submitted in paper form, enclosed in separate files and filed in a folder on which the title page is pasted.
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