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

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.