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National Repository of Grey Literature 2 records found  Search took 0.01 seconds. 
Approval system with automated check in web browser
 Svetosheva, Anastasia ; Travěnec, Jiří (referee) ; Kolářová, Jana (advisor)
This bachelor’s thesis focuses on the development of an approval system for the Ethics Committee, which is engaged in biomedical research. The aim of the thesis is to describe the functioning and requirements of the Ethics Committee and to consider how it is possible to incorporate these requirements into the approval system. Furthermore, the thesis will explore login methods for different types of users, such as applicants and committee members, and a database will be created and integrated. The approval system itself will include automatic checks where committee members will be notified by email after a change in the status of an application. The system will also include a daily automatic reminder by email if there are less than 10 days left until the end of the deadline for the Ethics Committee’s review. Within the framework of this thesis, potential processes for the approval of applications for biomedical research by the Ethics Committee will also be described, and possible methods of providing feedback will be proposed. The intention of this work is to create a functional and user-friendly approval system that effectively meets the requirements of theEthics Committee for biomedical research.
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Clinical trials of medical products for human use in the Czech Republic
 Baloušek, Filip ; Kryska, David (advisor) ; Svoboda, Petr (referee)
The issue of legislative and ethical requirements on research of innovative medicines became more intense in connection to the expansion of the pharmaceutical industry in last few decades. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the process of clinical trials of medicinal products for human use in the Czech Republic, as well as to take a closer look to the issue of ethical review administered by specialized ethical review committees. The author also deals with some specific responsibilities of the committees from the perspective of administrative law, especially focusing on aspects of legal nature of the positive opinions, which are one of the conditions for commencement of a clinical trial. The thesis is divided into nine chapters and the introductory chapter is focused on the general outline of the issue of clinical trials of medicines for human use in the Czech Republic. The aim of the second chapter is to define the basic concepts stated in the Czech medicinal products act, which are specific for this area of pharmaceutical law. The next chapter analyses the relevant competencies of individual state authorities over the clinical studies. The fourth chapter contains the list of sources of law, whereas a particular emphasis is...
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