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Focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members.
encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.
this guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.the principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects
the development of standard definitions and terminology for key aspects of clinical
safety reporting, and the appropriate mechanism for handling expedited (rapid) reporting, in the
investigational (i.e., pre-approval) phase
There are many quizzes on these sites. Terms such as “ACRP”, “SoCRA”, “ICH GCP”, “CCRP”, “CCRC”, “ethics in research”,” 46 CFR 46”, and “protecting human research”, among others, can be used to help find quizzes.
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