The Anatomy of a Clinical Trial Protocol: Important Concepts and Essential Terminology for Accurate Translation


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68 minutes


Beginning clinical trial documentation translators, translators wishing to add clinical trial documentation to their specializations, translators curious about clinical trials and their relationship to the international standard (ICH-GCP)
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Clinical trial documentation translation is increasingly growing in popularity. Therefore, it is absolutely essential for translators, especially those with no formal clinical training or experience, to have a solid understanding of the relevant concepts and terminology to provide an accurate translation of such documentation in their native language(s). Moreover, beginning translators must also understand these concepts within the context of the ICH-GCP, which is the international standard for good practices relating to clinical trials. Since a large part of the translation work in this area deals with amendments to the clinical trial protocol, this webinar will present the fundamental concepts and terminology that all successful clinical trial documentation translators must have about this very important document. This includes an in-depth presentation of each point of the GCP 6.0 guidelines using examples from actual clinical trials, as well as a discussion of the concepts and terminology relating to clinical trial protocols, such as substantial amendment, endpoint, open label, dose-escalation study, randomization and double-blinded study. The course materials include a pdf version of the PowerPoint presentation and a handout.

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February 27, 2014

Trainer Bio

Carmen Cross - Carmen Cross has been a professional medical translator of German and Arabic medical documents since 2005. She holds a Bachelor's and two Master's in Arabic language and linguistics, as well as an Arabic-English translation certificate from New York University. In addition to medicine and biotechnology, she is also interested in foreign language acquisition and linguistics. Like her page on Facebook.

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