Study Qualifications
We carefully review all support requests. IIS applications undergo extensive assessment by a cross-functional
team consisting of medical, clinical, and other technical staff.
The following criteria are important factors for assessing IIS proposals:
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Safety and welfare of the subjects
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Originality or novelty of research
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Scientific and statistical soundness
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Impact on clinical and commercial strategies
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Impact on intellectual property portfolio
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Consideration of good clinical practices (GCP)
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Consistency with governmental and corporate health care compliance directives
The IIS Program generally does not provide support for studies:
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That involve investigational/pre-cleared/pre-market devices
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In which the primary study objective is intended to support a registration effort, labeling changes, or other regulatory action
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