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The National Institutes of Health Clinical Research Training Program (CRTP) was a one-year education program aimed at highly qualified, research-oriented medical and dental students wanting to learn the theory and practice of clinical and translational research that ran from 1997 to 2012.
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]
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Health Sciences Online (HSO) is a non-profit online health information resource that launched in December 2008. The website hosts a virtual learning center providing weblinks to a collection of more than 50,000 courses, references, textbooks, guidelines, lectures, presentations, cases, articles, images and videos, available in 42 different languages.
The NIH Office of the Director is the central office responsible for setting policy for the NIH, and for planning, managing, and coordinating the programs and activities of all NIH components. The NIH Director plays an active role in shaping the agency's activities and outlook.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
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.
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
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