GCP Laws
The author of this report shall be comparing and contrasting the differences in laws relating to global clinical practice (GCP) around the world in addition to any regulations, guidance and standard operation procedures (SOP's) that relate to the same. Finally, there will be an explanation of how they all reflect the influence of the ICH's Guideline for Good Clinical Practice E6. While different countries and cultures tend to do things a bit differently, the overall international guidelines of good clinical practice are usually reflected regardless of where one goes and what culture or country one is talking about.
One agency that is certainly focused and centered on good clinical practice would be the Food and Drug Administration (FDA) in the United States. One example of the Food and Drug Administration's adherence to good clinical practice is that they will update their rules and regulations to reflect any changes in the laws that are enacted or changed by the United States Congress. There is also a publication issued with each change that explains what the change was, why the change was made, how the change was or will be made and so forth. The preamble of any such publication will include an environmental impact assessment, an analysis...
International Clinical Harmonisation PROPER SYSTEMS IN PLACE The International Congress Harmonisation WHO Principles of Good Clinical Practice Clinical research is conducted to insure the safety and efficacy of health and medical products and practices (WHO 2002). In the past, randomized controlled trials gave most of the information about the safety and efficacy of these products and treatments. Randomized clinical trials were considered the foundation of evidence-based medicine but reliably only when conducted according to
Consent of Subjects Included in Biomedical Research Informed Consent is the basis of the transfer of information to a subject who is a candidate to participate in a clinical trial. The process of obtaining informed consent is a moral and ethical component of clinical trials conducted under Good Clinical Practices (GCPs). A subject is informed of all aspects of a clinical trial that are determined relevant to their decision to
Consent Process Following a number of high-profile abuses of patients in experiments during the early 20th century, the need for an informed consent process became apparent. To determine the current state of affairs with this process, this paper reviews the relevant literature to explain the key issues and concerns for obtaining informed consent from study subjects and how this process reflects the code of conduct set forth in Section 4.8
Offshoring Country selection: China China, undeniably, represents one of the best markets to perform a clinical trial. It is home to the largest global urban population, and provides an extensive patient pool as well as a vast network of hospitals. The country boasts of nearly 1.4 million physicians/doctors and over 1 million technicians and nurses. Low medical staff salaries partly contribute to lowering clinical trial costs in China by around 50% of
Ethical Principles in Biomedical Research Biomedical research is a field of medical research which is used to assist and support the body of knowledge that is available in the field of medicine. It is divided into two major categories. The first is the evaluation of new treatments for both their efficacy and safety in what are known as clinical trials. This kind of research contributes in the development of new forms
International Congress on Harmonization Clinical research guidelines There are various bodies that are concerned with the stipulation of guidelines and rules that need to be followed within the medical field and in specific the clinical research areas. The guidelines have been summarized by the International Conference on Harmonization (ICH) into five major areas: those dealing with quality, safety, efficacy and multidisciplinary topics. Within the patient care discipline, guidelines are designed predominantly to
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