Well-conducted clinical trials are essential to developing our evidence base for medical care. However, the regulatory guidelines and differing operations surrounding clinical trials can be daunting and difficult for new investigators. New investigators often find themselves trying to learn clinical trial management on the go, as this aspect of research is not routinely taught in medical school or residency. To address this problem, this article explains clinical trial startup, including the regulatory and operational aspects of investigator-initiated trials, multicenter trials, and different funding sources (government, foundation, and industry). We also include tables of over 30 common acronyms used in clinical trial operations and discuss common research infrastructure and protocols. The goal of this article is to collate study startup knowledge and materials in one place to build the emergency medicine pipeline of clinical trialists and researchers.
Southerland et al. (Sat,) studied this question.
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