Your Study’s Regulatory Binder

Human Research Regulatory Affairs Your Study’s Regulatory Binder
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Human Research Regulatory Affairs Your Study’s Regulatory Binder

As a researcher at NYU School of Medicine, you use a regulatory binder to store and organize required and useful study documents and correspondence. An up-to-date regulatory binder facilitates the effective and efficient management of studies and should help decrease procedural errors. An organized regulatory binder also helps maintain continuity in the event of staff changes. 

The entire research team should be familiar with the regulatory binder, but one person, or at most two, should be designated to maintain and update the binder. Study regulatory binders are not required but are considered a best practice. We offer the following templates and guidance for the development of study-related regulatory binders: