Einreichung und Begutachtung klinischer Studien bei Ethik-Kommissionen

Overview & Synopsis

Clinical research requires clear standards. However, the process of evaluating such research through ethics committees is complex. This handbook provides a guide to the ethical, legal, and methodological principles that must be observed when submitting applications for and evaluating clinical trials. It specifically addresses requirements for investigators and trial sites, benefit-risk assessment, clinical research methodology, informed consent and the protection of trial participants, vulnerable groups, and issues regarding data protection and biological samples. In doing so, it presents the distinct regulations governing trials of medicinal products, medical devices, and other types of clinical studies, explaining them in detail and with a practical focus. The handbook is intended for members and administrative staff of ethics committees, researchers and companies submitting applications, regulatory and supervisory authorities, and anyone else involved in clinical research.