{"id":82670,"date":"2021-03-02T11:39:35","date_gmt":"2021-03-02T09:39:35","guid":{"rendered":"https:\/\/aslimnica.lv\/education-and-science\/science-department\/zalu-izpetes-kliniskie-petijumi\/"},"modified":"2026-03-03T13:15:06","modified_gmt":"2026-03-03T11:15:06","slug":"clinical-research-trials","status":"publish","type":"page","link":"https:\/\/aslimnica.lv\/en\/education-and-science\/science-department\/clinical-research-trials\/","title":{"rendered":"Clinical research trials"},"content":{"rendered":"

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R\u012bgas Austrumu kl\u012bnisk\u0101 universit\u0101tes slimn\u012bca<\/span><\/span> is one of the largest centres for clinical drug research in Latvia. Each year, more than 80 clinical trials aimed at the development of various medicinal products or medical devices are conducted at the hospital. Clinical research is carried out in the fields of oncology, cardiology, neurology, pulmonology, endocrinology, surgery, ophthalmology, gastroenterology and other medical specialties.<\/p>\n<\/div>\n

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Clinical drug research is conducted in accordance with the internal regulations \u201cRegulations on the Implementation of Research\u201d, approved on 10 July 2025.<\/p>\n

In accordance with Cabinet Regulation No. 192 of 26 March 2024 \u201cRegulations Regarding Clinical Trials of Medicinal Products for Human Use\u201d, the classification of clinical research has been specified as follows:<\/p>\n

Clinical trial (clinical study of new, non-registered medicinal products);
Low-intervention clinical trial (clinical study of registered medicinal products);
Non-interventional study (a study in which neither non-registered nor registered medicinal products or medical devices are investigated);
Clinical trial of medical devices.<\/p>\n

The application form for conducting clinical studies has been updated in accordance with the new classification of clinical research.<\/p>\n

To apply for a clinical study, the following documents must be submitted to the Research Department:<\/strong><\/p>\n

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    An application for conducting a clinical study<\/a>, signed by the principal investigator, the head of the clinic or department where the study is planned to be conducted, the chief physician, and the sponsor or its representative;<\/p>\n<\/li>\n

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    The study protocol or its summary (synopsis), preferably in Latvian;<\/p>\n<\/li>\n

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    The study timeline.<\/p>\n<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/article>\n<\/div>\n

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    The Research Department shall evaluate the application and, in the case of a positive assessment, recommend that a person delegated by the Board sign the Site Suitability Form or issue confirmation letters on behalf of R\u012bgas Austrumu kl\u012bnisk\u0101 universit\u0101tes slimn\u012bca<\/span><\/span> to the State Agency of Medicines and the ethics committee specified in the application, confirming the hospital\u2019s consent to conduct the study.<\/p>\n

    The study sponsor or its delegated representative shall submit the clinical trial implementation contract for coordination with the specialists of the Research Department, Legal Department and Economic Department.<\/p>\n

    The Research Department shall submit the coordinated contract, signed by the sponsor or its authorised legal representative, to the Board\u2019s delegated person for signature.<\/p>\n

    After the contract is signed, the Board\u2019s authorised person shall issue an order, prepared by the Research Department, regarding the initiation of the study.<\/p>\n

    The principal investigator shall be responsible for:<\/p>\n

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    1. Conducting the study in accordance with the study protocol;<\/li>\n
    2. Informing the Research Department about the completion of the study;<\/li>\n
    3. Submitting study documents to the Research Department for archiving.<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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