What the committee does
Authorisation to conduct a clinical study is issued by the Ministry of Health of Russia after an expert review of the documents and an ethics review carried out by the Ethics Council established by the Ministry.
The local ethics committee was set up at the clinic for the ethical and legal review of the studies the clinic conducts, and to protect the rights of patients and doctors. The committee reviews all study documents, including the information that patients and volunteers will read and sign.
The committee is organised in accordance with the requirements of Good Clinical Practice (GCP), the Declaration of Helsinki and the legislation of the Russian Federation. The committee’s work is described in standard operating procedures (SOPs).
How the review works
- We give the meeting schedule and review times when the documents are submitted — for your project.
- The document package is accepted in electronic form.
- A package can be reviewed before authorisation to conduct the clinical study has been received.
- The committee’s services are provided free of charge.
How to submit documents
Send the study document package through the request form or call us, and we will tell you what to attach. To have the protocol assessed before you submit the documents, see feasibility assessment.
Questions and answers
What does the ethics committee review?
All study documents, including the information for participants and the informed consent form. The committee’s task is to make sure that all measures have been taken to protect participants’ safety and rights.
See also
Feasibility assessment of a clinical study
A feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
Learn more
Quality management system
Participant safety and data reliability are ensured by a quality management system: standard operating procedures, internal and external audits and regular staff training.
Learn more