REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot87610.21518/1561-5936-2021-1-4-8Original ArticleCRA University - School of Clinical Trial Monitors: 10 years of successSemenov-Tyan-ShanskiyV. L.noemail@neicon.ruBal’TserovichA. S.noemail@neicon.ruSazonovaA. N.noemail@neicon.ruLoginovskayaO. A.noemail@neicon.ruVerbitskayaE. V.noemail@neicon.ruMalikovaE. A.noemail@neicon.ruKolbinA. S.noemail@neicon.ruZvartauE. E.noemail@neicon.ruPavlovichD. M.noemail@neicon.ruIQVIAPavlov First Saint Petersburg State Medical UniversityFlex DatabasesDM 3651312202114818032022Copyright © 2021,2021This article presents the history and structure of the school of clinical trials monitors in Russia, the reasons for its opening in 2011, as well as the results of a survey of graduates. The authors discuss in detail what tasks they faced in creating a high-quality, modern, interactive educational program that is sustainable in the long term. Shows the important role of collaboration between academic institutions and business companies directly involved in clinical research on a daily basis. The structure of the course is presented, as well as teaching materials and electronic systems and technologies are used. Separately, the experience of operating a school during the COVID-19 pandemic is given, an analysis of the course functioning in fully online format, the positive and negative aspects of this approach. The second part of the article presents the results of a survey of graduates of the course for 9 years: from their satisfaction with training, to their further professional career (a total of 8 questions). In conclusion, the authors present their personal attitude to this educational project.ICH GCPCRACROEDCTMFmonitoringclinical trial monitoreducationGood Clinical Practicecontract research organizationICH GCPCRACROEDCTMFмониторингмонитор клинического исследованияобразованиеНадлежащая клиническа практикаконтрактная исследовательская огранизация[«Школа мониторов» (CRA school). Режим доступа: https://www. clinpharm-spbgmu.ru/education/ CRA_school.php.][Ассоциация организаций по клиническим исследованиям (АОКИ). Информационно-аналитический бюллетень №3. IV квартал и итоги 2011 года. Режим доступа: http://acto- russia.org/files/bulletin_3.pdf.][Приказ Министерства здравоохранения РФ от 1 апреля 2016 г. №200н «Об утверждении правил надлежащей клинической практики» Режим доступа: https://www.garant.ru/products/ipo/prime/doc/71373446/.][ГОСТ P 52379-2005 «Надлежащая клиническая практика». Дата введения: 01.04.2006 г.][Федеральный закон «Об обращении лекарственных средств» №61-ФЗ от 12.04.2010. Дата введения: 01.09.2010 г.][Приказ Министерства здравоохранения РФ №200н «Об утверждении правил надлежащей клинической практики». Дата введения: 01.04.2016 г.][Правила надлежащей клинической практики Евразийского экономического союза. Утверждены решением Совета Евразийской экономической комиссии от 03.11.2016 г. №79.][ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice (E6R2). November 2016.][IQVIA CRA School. Available at: https://www.iqvia.com/pl-pl/ locations/poland/iqvia-cra-school.][Logunov D., Dolzhikova I., Shcheblyakov D., Tukhvatulin A., Zubkova O., Dzharullaeva A. et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021;397(10275):671-681. doi:10.1016/S0140-6736(21)00234-8.]