Attribut:Beschreibung-EN
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Dies ist ein Attribut des Datentyps Text.
K
'''Qualification goals''' After participating in the module, students will be able to name, explain and apply ethical and legal aspects. These include: regulatory requirements and data standards for medical research; policies, ethical and regulatory frameworks for handling information in healthcare; ethical aspects and security issues, including accountability of providers, managers and BMHI specialists, as well as confidentiality and security of patient data; essential principles of data protection, including DSGVO (the European Union's General Data Protection Regulation) and Cyber Security Act; the concepts of pseudonymized and anonymized patient data. </br> '''Content''' The lecture "Regulatory Aspects of Clinical Research" deals with the legal basis of clinical research as well as its regulatory framework. The following topics are covered in the lecture "Regulatory Aspects of Clinical Research": Introduction to the legal framework and regulatory basis; data protection and concepts for data protection compliant implementation in clinical research; biomaterial banks; quality management according to AMG and MPG/MDR as well as implementation according to GAMP. In the section "Special Areas of Regulatory Aspects of Clinical Research", practitioners from various healthcare institutions will report on regulatory aspects (electronic signature, digital archiving, robotics, etc.) In the seminar, selected topics from the lectures will be deepened by the students in the context of group work with practical exercises and a concluding lecture. +
L
Basic functionalities of a typical clinical workplace system (KAS) (e.g. requesting examinations, documenting findings as well as prescribing medication and writing medical reports) +
data to be processed and provided and enterprise functions to be supported by Nursing Management and Documentation Systems and their user groups +
Students describe the need for medical documentation on the basis of examples. +
Students know the various types of medical documentation, their structure and fields of application, in particular the basic documentation of hospitals and medical practices +