Quality assurance


7 July 2020

Quality assurance in non-commercial clinical trials under the auspices of LRI CZECRIN

Setting up a functional quality management and assurance system is one of the legal conditions for conducting regulated clinical trials, including the sponsor or an authorized institution. Hospitals and universities that have decided to carry out their own clinical studies are no exception. Each such organization must have an interconnected system of written work procedures and records to the extent required by legislation, SÚKL guidelines and good practices (clinical, laboratory or production).

In line with long-term priorities aimed at supporting non-commercial clinical trials, LRI CZECRIN focused on quality management and assurance. The Center for Clinical Studies at LF-MUNI, established with the support of LRI CZECRIN, has a comprehensive quality system covering the activities of the sponsor or authorized institution, which has been inspected by SÚKL and an external independent audit. LRI CZECRIN has decided to share this quality system with all 12 hospitals that are involved in the CZECRIN Clinical Trial Units Network. Part of this agenda are regular meetings and trainings provided by the quality manager, Mgr. Leoš Ševčík, coordinators of the participating hospitals and the creation of a working group that aims to develop and harmonize the area of ​​quality for non-commercial clinical trials.