Publication details
ORGANIZAČNÍ ZAJIŠTĚNÍ AKADEMICKÝCH KLINICKÝCH STUDIÍ
| Title in English | Organizational support for academic clinical trials |
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| Authors | |
| Year of publication | 2023 |
| Type | Conference abstract |
| MU Faculty or unit | |
| Citation | |
| Description | In 2014, by the decision of the Ministry of Education and Culture, the large research infrastructure CZECRIN was established to create a nationwide scientific network of partners for the implementation of academic clinical research and clinical studies at the national and international levels. The CZECRIN infrastructure represents the Czech national node of the pan-European research infrastructure ECRIN-ERIC, which connects clinically oriented research capacities in CR with the research and application sphere in Europe and the world. Similar to other clinical research infrastructures within ECRIN-ERIC, WI CZECRIN does not have the status of a legal entity, and the host institution is Masaryk University Brno. CZECRIN has a unique network, including the most important clinical workplaces with an orientation to clinical research, and provides knowledge, development, production, and implementation capacities in the research and development of medicines and medical devices. It sets the quality of processes and data and builds an education system, the CZECRIN Academy, enabling the use of the knowledge and experience of biomedical research experts. The expert team of the CZECRIN clinical studies unit provides comprehensive and partial services for the implementation of non-commercial clinical studies and research in the field of medicinal products, diagnostic methods, and medical devices following the strict rules of Good Clinical Practice, the Declaration of Helsinki and EU and CR legislation. The list of necessary activities includes the preparation of study documentation, medical writer services, processing of the study at the regulatory authority and the ethics commissions, project management of the study, monitoring, pharmacovigilance, data management, biostatistics, and consulting and advisory activities. The key tool in the organization, management, and logistics of clinical trials is the Quality Assurance system, which must be in the background of all steps that affect patient safety and data reliability. QA also ensures compliance with the requirements of national and international standards and regulations. VVI CZECRIN, therefore, also helps with the implementation and maintenance of quality assurance systems and with the creation of SOPs, forms, and templates. The expert team in the field of regulations and pharmacoeconomics then helps with the definition and management of the regulatory strategy and with the economic aspects that are important for the successful development of products in the field of medicine and decide on the availability of treatment for the patient. |
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