Design your clinical study

Designing a study forces you to clarify your concepts and develop a goal. While challenging to consider all aspects of the process, the CRO can guide you, ensuring that you create a clinical study with relevant and reportable outcomes.

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In preparing for submission to the Institutional Review Board (IRB), faculty members consult with the CRO staff for protocol development and to review their clinical research studies for operational feasibility.
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An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy.

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An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).

6/28/17

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.