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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. [1] Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. [2]
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
The UN Principles of Medical Ethics is a code of medical ethics relating to the "roles of health personnel in the protection of persons against torture and other cruel, inhuman or degrading treatment or punishment.", adopted by the United Nations on 18 December 1982 at the 111th plenary meeting of the United Nations General Assembly.
A framework for action in and through the NHS. London: NHS Executive, 1996; National Institute of Clinical Excellence, Principles of Best Practice in Clinical Audit. London: NICE, 2002 ISBN 1-85775-976-1; Swage T.; Clinical governance in health care practice. Oxford: Butterworth-Heinemann, 2000
The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A ...
Clinical audit is the review of clinical performance, the refining of clinical practice as a result and the measurement of performance against agreed standards – a cyclical process of improving the quality of clinical care. In one form or another, audit has been part of good clinical practice for generations.