?:definition
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Specifies whether this study must be registered as required by applicable laws. EXAMPLE(S): OTHER NAME(S): Section 801 Clinical Trial NOTE(S): Under US Public Law 110-85, Title VIII, Section 801, applicable drug trials include controlled clinical investigations, other than Phase I investigations, of a drug or biologic subject to US FDA regulation. Applicable device clinical trials are controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric postmarket surveillance.
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