This form is a New Case Investigation Checklist usable in cases where licensing, patents, or commercial trade secrets are an issue.
Virgin Islands New Case Investigation Checklist
State:
Multi-State
Control #:
US-TS10063
Format:
Word;
PDF;
Rich Text
Instant download
Description
How to fill out New Case Investigation Checklist?
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FAQ
(ii) Applicable device clinical trial The term ?applicable device clinical trial? means? (I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine ...
Applicable Clinical Trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FDAAA.
The NIH clinical trial definition is: A research study1 in which one or more human participants2 are prospectively assigned3 to one or. more interventions4 (which may include placebo or other control) to evaluate the effects of those. interventions on health-related biomedical or behavioral outcomes.5.
