Glossary of Terms and Acronyms
- 510K device
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Regulatory term. A 510(k) is a pre-market submission made to the FDA for the purpose of demonstrating to the FDA that the device to be marketed…
- administrative closure
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Closure of an IRB-approved study or of an application for any type of HSD determination or UW IRB approval that is initiated by HSD (not the…
- adverse event (AE)
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Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), system, or disease temporally…
- applicable clinical trial
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This refers to the specific types of clinical trials that are required to comply with federal requirements about registration and results reporting at the federal website…
- approved drug
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Drug products approved by the FDA. See the FDA website at: https://www.fda.gov/drugs/drug-approvals-and-databases/resources-information-approved-drugs
- assent
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Regulatory term. Agreement to participate in research by an individual who is not competent to give legally valid informed consent (e.g., a child or cognitively impaired…
- assurance
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Regulatory term. A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research…
- authorization agreement
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See: reliance agreement
- Authorized Institutional Official (IO)
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Regulatory term. An official of an institution who has the authority to speak for and legally commit the institution to compliance with the requirements of the…
- autonomy
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An individual’s right to consider alternatives, make choices, and act without undue influence or interference of others. See: Belmont Report
