Register of accredited organizations conducting clinical trials. Conducting clinical trials of medicinal products

Before allowing the sale of medical products, clinical trials of drugs are prescribed. The process consists of the following stages:

Study. Healthy volunteers are selected, the pharmacology of the drug is studied, its effect on the human body. The results allow us to determine what developments will be required in the future.
Working with sick participants. After establishing the fact of the safety of the drug, it is tested on people who have characteristic diseases, syndromes. It is determined how effective the remedy is, how it helps.
Establishment adverse reactions... At this stage, the therapeutic values \u200b\u200bof the drug are determined.
Indications and dosage. It is determined how long the medicine can be taken, in what quantity, for what symptoms.

GlobalPharma Clinical Research Center has extensive experience in testing, detailed study of drugs.

What is offered to clients?

Cooperation is carried out on the basis of an agreement signed by both parties. The agreement confirms that the participants are not opposed to the CI. After that, the terms of the procedure, the design of clinical studies of the effectiveness of drugs are discussed. The contract research organization offers:

Development of a complete package of documentation required for the CT.
Development of detailed argumentation, calculations, sampling.
Preparation of the dossier, transfer of documents to the Ministry of Health.
Submission of documentation to the Ministry of Health, obtaining an expert opinion.
Formation of the final package of documentation, on the basis of which the registration dossier will be drawn up.

Clinical trials in Moscow are carried out after obtaining permission from the Ministry of Health of Russia. Employees will prepare the center, submit a request to the Environmental Control Laboratory, process the data, analyze the information.

There are two resources most often used to find clinical trials conducted in Russia. The first is the official register of the Russian Ministry of Health www.grls.rosminzdrav.ru. Its advantage is that it is in Russian and contains a list of medical centers in Russia where research is being conducted. The second, www.clinicaltrials.gov, is the US National Institutes of Health's International Clinical Trials Registry. This resource is helpful for more details and important information research such as inclusion criteria, but it is being conducted on english language... Therefore, when looking for a clinical trial, we recommend using the two resources in parallel.

§one. Search for a clinical trial on the website www.grls.rosminzrav.ru

The following describes how to search for a study by specific criteria.

Step 1. Go to the site http://www.clinicaltrials.gov/ and select the section "Advanced search"

Recruitment - select Open studies (studies in which the recruitment of patients is already underway, or has not yet begun, as well as expanded access programs);
Study Type - select Interventional Studies;
Conditions - diagnosis in English;
Country 1 - Russian Federation (It should be noted that Russian Federation is not always indicated in the list of countries, therefore we also recommend re-performing the search without specifying the country);
Search - search.

Step 3. If your search returned results, you will see a list of studies matching your query parameters.

Step 4. You can get acquainted with more detailed information by clicking on the line with the research you are interested in.

Pay special attention for the following information:

Purpose - the purpose of the research;
Drug - name medicinal product;
Eligibility - criteria for inclusion in clinical research.
Other Study ID Numbers - protocol numbers for identification in other registries, including for searching in the register of the Ministry of Health of Russia.

Step 5. If you think that you have found a suitable clinical trial, the next step is to check if it is ongoing in Russia. To do this, go to the website www.grls.rosminzdrav.ru and try to find this study in the register of the Ministry of Health of Russia - see §1.

The study can be found by the protocol number listed in the "Other Study ID Numbers" row. If this line contains more than one protocol number, try alternate search.

Clinical trials are carried out only after obtaining a special permit from the Ministry of Health of the Russian Federation (MH RF) to conduct a clinical trial. To obtain a permit, it is necessary to prepare a package of documents for a clinical trial in paper and electronic form, pay a state fee and apply for a permit from the Ministry of Health of the Russian Federation to the Department of State Regulation of Circulation medicines (Moscow, Rakhmanovskiy lane, 3) and on the portal http://grls.rosminzdrav.ru

The package of documents includes:

A copy of the document confirming the payment of the state fee;

Clinical trial protocol;

Investigator's Brochure;

Patient information sheet;

Information about the experience of researchers in the relevant specialties and their experience in conducting clinical trials;

Information about the medical organizations in which the clinical trial is supposed to be carried out;

Information on the expected timing of a clinical trial of a medicinal product for medical use;

A copy of the compulsory insurance contract;

Information on the composition of the medicinal product for medical use;

A document drawn up by a manufacturer of a medicinal product for medical use and containing indicators (characteristics), as well as information about a medicinal product for medical use produced for clinical trials;

A copy of the license for the production of medicinal products (for the manufacture of the drug in the Russian Federation) or a copy of the conclusion on the compliance of the manufacturer of the medicinal product with the requirements of the Good Manufacturing Practice rules issued by the competent authorized body of the country that manufactures the medicinal product.

Ministry of Health of the Russian Federation, within 5 working days from the date of acceptance of the application and the necessary documents:

Checks the completeness and accuracy of the information contained in the submitted package of documents;

Decides to conduct an examination of documents to obtain permission to conduct a clinical trial and ethical examination or to refuse to conduct these examinations;

Notifies the applicant in electronic form or on paper about the decision;

Prepares and submits to the Ethics Council and an expert institution (FSBI "NTs ESMP" of the Ministry of Health of the Russian Federation) a task for carrying out appropriate examinations. The expert commission and the Ethics Council draw up conclusions on the possibility or impossibility of conducting such a clinical trial and send these conclusions to the Ministry of Health of the Russian Federation within a period not exceeding 30 working days from the date of receipt of the assignment.

All approved clinical trials are entered into the Register of Approved Clinical Trials and are available on the portal http://grls.rosminzdrav.ru.

Roszdravnadzor ( federal Service for supervision in the field of health care http://www.roszdravnadzor.ru). According to the order of the Ministry of Health of September 29, 2011, the Administrative Regulations of Roszdravnadzor were approved for the implementation of the state function of supervising the conduct of preclinical and clinical trials of drugs intended for medical use.

Roszdravnadzor carries out:

Current and emergency checks of legal entities engaged in
organizing and directly conducting
clinical and preclinical research;

Receiving and analyzing data provided by departments
Roszdravnadzor, on clinical trials.

When conducting an inspection, authorized persons of Roszdravnadzor are also obliged to:

Not to prevent the head or an authorized representative of a certain entity performing the research organization from being present during the inspection and providing explanations on questions regarding the subject of the inspection;

On the facts of detected violations, take measures proportional to the severity of violations, their possible threat to life and health of people;

Do not request from the subjects conducting the organization of research documents, the submission of which is not provided for by the legislation of the Russian Federation, as well as documents that can be obtained from other state control bodies.

Clinical research can only be carried out in a research center accredited by the Ministry of Health of the Russian Federation. There is a list of accredited centers, which is systematically supplemented and changed. The current list of accredited research centers, as well as orders of the Ministry of Health of the Russian Federation on the accreditation of medical organizations for the right to conduct clinical trials are available on the portal http://grls.rosminzdrav.ru

After the completion of the clinical trial, the applicant submits a report with the results of the clinical trial to the Ministry of Health of the Russian Federation within a period not exceeding 3 months from the date of its completion.

More details can be found in the manual "Clinical Trials Management".

The manual is divided into eight Sections.