Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Gauge theory of a group of diffeomorphisms. I. General principles

Any (N+M)-parameter Lie group G with an N-parameter subgroup H can be realized as a global group of diffeomorphisms on an M-dimensional base space B, with representations in terms of transformation laws of fields on B belonging to linear representations of H. The gauged generalization of the global diffeomorphisms consists of general diffeomorphisms (or coordinate transformations) on a base space together with a local action of H on the fields. The particular applications of the scheme to space-time symmetries is discussed in terms of Lagrangians, field equations, currents, and source identities. Journal of Mathematical Physics is copyrighted by The American Institute of Physics.

General principles of the design of trawl net

The classification and the principles of design and construction of trawls in general are described. The method of calculating the length of rope required at each part for mounting the net and the requirements of floats and sinkers are given. The cutting rates to tailor machine made webbing are also indicated.

An overview of liability and compensation for personal injury in China under the general principles of civil law

This article reviews the personal injury tort system in the People's Republic of China (PRC). The Chinese torts law has a number of unique features. To begin with, it is quite new — the legal framework of torts law was established only in 1986. The unique features of the Chinese torts law also stem from its long and difficult evolution over nearly 40 years. Equally important has been the remarkable blend of influences that have shaped its current law — a mixture of socialist objectives, capitalist pragmatism, and feudal doctrines combined with jurisprudential models taken from a range of western civil codes and, more recently, the common law.

Part one of the article briefly analyses the most important features of the existing Chinese legal system. Part two provides a background to the enactment of the General Principles of Civil Law (GPCL), which incorporates Chinese torts law. The review looks at the development and drafting of the GPCL legislation, and the influences that guided the formulation of legal principles. Part three of the article provides an overview of the torts law provisions in the GPCL. Part four examines the law of personal injury established by the GPCL. Part five uses some case studies to illustrate the principles highlighted in the previous two parts and part six contains a brief conclusion and some pointers to the directions that Chinese torts law may take in the future.

General principles of therapy of pyogenic meningitis

In bacterial meningitis, several pharmacodynamic factors determine therapeutic success-when defined as sterilization of the CSF: (1) Local host defense deficits in the CNS require the use of bactericidal antibiotics to sterilize the CSF. (2) CSF antibiotic concentrations that are at least 10-fold above the MBC are necessary for maximal bactericidal activity. Protein binding, low pH, and slow bacterial growth rates are among the factors that may explain the high antibiotic concentrations necessary in vivo. (3) High CSF peak concentrations that lead to rapid bacterial killing appear more important than prolonged suprainhibitory concentrations, probably because very low residual levels in the CSF prevent bacterial regrowth, even during relatively long dosing intervals. (4) Penetration of antibiotics into the CSF is significantly impaired by the blood-brain barrier and thus, very high serum levels are necessary to achieve the CSF concentrations required for optimal bactericidal activity. Beyond these principles, recent data suggests that rapid lytic killing of bacteria in the CSF may have harmful effects on the brain because of the release of biologically active products from the lysed bacteria. Since rapid CSF sterilization remains a key therapeutic goal, the harmful consequences of bacterial lysis present a major challenge in the therapy of bacterial meningitis. Currently, dexamethasone represents that only clinically beneficial approach to reduce the harmful effects of bacterial lysis, and novel approaches are required to improve the outcome of this serious infection.

Analysis of the "European Charter on General Principles for Protection of the Environment and Sustainable Development" The Council of Europe Document CO-DBP (2003) 2

Analysis of the "European Charter on General Principles for Protection of the Environment and Sustainable Development" The Council of Europe Document CO-DBP (2003) 2

European Criminal Law and General Principles of Union Law. Research Papers in Law, 5/2005

From the Introduction. The European Court of Justice, partly followed in this by the European legislator, has regulated Community law and policy through a set of general principles of law. For the Community legal order in the first pillar, general legal principles have developed from functional policy areas such as the internal market, the customs union, the monetary union, the common agricultural policy, the European competition policy, etc., which are of great importance for the quality and legitimacy of Community law. The principles in question are not so much general legal principles of an institutional character, such as the priority of Community law, direct effect or Community loyalty, but rather principles of law which shape the fundamental rights and basic rights of the citizen. I refer to the principle of legality, of nulla poena, the inviolability of the home, the nemo tenetur principle, due process, the rights of the defence, etc. Many of these legal principles have been elevated to primary Community law status by the European Court of Justice, often as a result of preliminary questions. Nevertheless, a considerable number of them have also been elaborated in the context of contentious proceedings before the Court of Justice, such as in the framework of European competition law and European public servants law.

Decentralisation of EC Competition Law Enforcement and General Principles of Community Law. Research Papers in Law, 4/2004

From the Introduction. By virtue of Council Regulation No. 1/2003, as of 1st May 2004 the full application of EC competition law will be entrusted to national competition authorities (hereinafter NCAs) and national courts. The bold reform of EC competition law enforcement adheres to the system of executive federalism1 which characterises the EC legal system. The repartition of competences within the Community allocates implementation of Community law mainly at Member States level. Pursuant to Article 10 EC, they are responsible for the implementation of the measures which have been adopted at Community level for the achievement of the objectives specified in the EC Treaty. Consequently, the attainment of the Community objectives depends very much upon the cooperation of national authorities, which act in accordance with their own national procedural rules.2 The various national procedural rules present themselves as conduits through which Community law is implemented and enforced. While as a rule Community law is not designed to alter national procedural rules, the Community legal order cannot afford to leave national procedural rules untouched when they are liable to hamper the effective application of Community law....For reason of space, this contribution intends only to highlight some aspects of Regulation No. 1/2003 with regard to which general principles of Community law are able to condition national procedural rules.

General Principles of EU Law: The Ghost in the Platonic Heaven in Need of Conceptual Clarification. Pittsburgh Papers on the European Union Vol. 2, 2013

General principles are en vogue in EU law – and in need of conceptual clarification. A closer look at several concepts of principle in legal philosophy and legal theory sheds light upon the concept of general principles in EU law. A distinction between an aprioristic model of principle and a model of principle informed by legal positivism may contribute to clarifying the genesis of a (general) principle in EU law, as well as its nature and functions. This paper demonstrates that an evolution has taken place from a reliance on seemingly natural law inspired reflections of general principles via the desperate search to ground general principles in various kinds of sources based on a more or less sound methodology towards an increasing reliance on strictly positivistic approaches. Against this backdrop, general principles are likely to lose significance where there are other norms while retaining an important yet uncontrollable role where the traditional canon of sources is silent.

Horse-breeding, being the general principles of heredity applied to the business of breeding horses, with instructions for the management of stallions, brood mares and young foals, and the selection of breeding stock,

Mode of access: Internet.

Network transduction based on permissible functions : general principles of NOR network transduction NETTRA programs /

Includes bibliographical references.

General principles proposed for staff management /

Letter from Carl M. White, and letter from the comittee precede statement of principles, dated December 24, 1941.