Clinical Trials and Medical Documentation: Resources and Translation Strategies for New Translators
The course provides translators with a solid foundation for translating medical documentation relating to clinical trials. This includes international standards, regulatory bodies, an introduction to the clinical trial pipeline and other issues involving clinical trials, where clinical trials are currently being conducted and the various types of clinical trial documentation. The presenter will discuss the common issues that may arise when translating each type of text, as well as relevant terminology that is often confused, such as "efficacy vs. efficiency" and "patient vs. subject." Various strategies that translators at any stage in their careers can use to improve their consistency and accuracy when translating such documents will also be presented.
The following topics will be discussed:
• The international standards that govern clinical trials
• The different stages of drug discovery and development, from preclinical to post marketing authorization
• The 4 phases of clinical trials and how they impact the clinical trial process of a drug
• The various types of clinical trial documentation, such as SmPC, Informed Consent Form and Patient Information Leaflet
• Essential pharmacokinetic metrics. These metrics include CMAX, CMIN, tMAX and AUC (area under the curve).
• Advanced search techniques to enable medical translators to locate information on the Internet.
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General discussions on this training