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Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe., Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action., Results: Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know-how and documents. Since harmonization was mainly a bottom-up approach up until now, the extent and topics dealt with are diverse and there is only little cross-networking and cross-country exchange so far., Conclusions: Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country., Competing Interests: The authors affirm that they have no conflicts of interest to disclose. This survey was conducted with no external funding or specific internal funding and was done within the usual employment contracts., (© 2020 The Authors. Learning Health Systems published by Wiley Periodicals, Inc. on behalf of the University of Michigan.)

Clinical trials are an important part of clinical research. The conduction of clinical trials is strictly regulated and has to comply with an approved protocol. Local regulatory authorities, independent ethic committees, sponsors of clinical trials as well as the investigators are involved from the submission until the very end of the trial. All clinical trials performed in the Czech Republic have to be approved by the State Institute for Drug Control and by the Ethics Committee. The regulatory bodies and independent ethics committees evaluate and continuously supervise the justification and protocol of the clinical trial, quality of the investigational medicinal products and, primarily, the safety of the participants (patients and/or healthy volunteers) in clinical trials. In the Czech Republic there are many advanced clinical research centres, either located in private practices or within hospitals. The investigators are able to conduct a wide variety of clinical trials and recruit a high number of subjects for the trials, as well as to comply with the Good Clinical Practice guidelines and other regulatory requirements. The aim of this article is to summarise the current situation of clinical trials in the Czech Republic as well as the opportunities for getting involved in clinical trials and obligations arising for health professionals from such an involvement.

Objective: In 2005-2010, a nosocomial infection prevalence study was conducted in 12 university hospitals, namely at the departments of surgery, urology, neurology, cardiology, neurosurgery, otorhinolaryngology, and traumatology. The primary objective was to evaluate the overall epidemiological situation of nosocomial infections (NI) at the highest risk departments of selected healthcare facilities in the Czech Republic and to characterize the NI detected., Methods: To collect data, a questionnaire survey method was used, as it suited the routine operation conditions in healthcare facilities and was inexpensive, easy to understand, reproducible, and repeatable if needed. The questionnaire was designed according to the protocol recommended by the working group HELICS (Hospital in Europe Link for Infection Control through Surveillance). In each of the participating hospitals, the medical records of all patients hospitalized at the respective departments were analyzed. The patient data, hospitalization data, potential risk factors, and occurrence of hospital infection, if any, were derived from the medical records and entered in the questionnaire., Results: Overall, data on 1889 hospitalized patients were analyzed. Eighty-one confirmed NI cases were found, i.e. the prevalence rate in this study was 4.3% (the percentage of HI per the number of hospitalized patients), which is in agreement with the recent data reported in the European Union. The most common causative agents were Pseudomonas spp. (16%), Staphylococcus aureus (15%), Escherichia coli (12%), Proteus spp. (10%), and Klebsiella spp. (4%), with the urinary tract (41%) and respiratory tract (23%) being affected most often.