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…
- administrative closure
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Closure of a study that no longer has IRB approval because the approval lapsed or…
- adverse event (AE)
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Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for…
- approved drug
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Drug products approved by the FDA. See the FDA website at: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
- assent
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Regulatory term. Agreement to participate in research by an individual who is not competent to…
- assurance
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Regulatory term. A formal written, binding commitment that is submitted to a federal agency in…
- authorization agreement
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See: reliance agreement
- Authorized Institutional Official
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Regulatory term. An official of an institution who has the authority to speak for and…
- autonomy
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An individual’s right to consider alternatives, make choices, and act without undue influence or interference…
- Belmont Report
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A report that sets out the basic ethical principles governing research involving human subjects, which…