Glossary of Terms and Acronyms
- minor noncompliance
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Noncompliance that is neither serious nor continuing.
- multi-site research
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Research study in which the same research procedures are performed at multiple sites. There is often a lead institution that is the prime recipient of the…
- non-significant risk device
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An investigational device that does not meet the definition of a significant risk device. This is not the same as the concept of “minimal risk” as…
- noncompliance
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An action or omission on the part of the researcher or IRB that is inconsistent with any of the following: The ethical principles of human subjects…
- off-label use
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The clinical use of an FDA-approved drug, device or biologic for a purpose or population that has not been approved by the FDA, or in a…
- over-enrollment
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The total number of subjects enrolled in a study (excluding withdrawals) is greater than was approved in the initial IRB application or in a subsequent modification.
- permission (parental)
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The agreement of parent(s) or guardian to the participation of their child or ward in research.
- primary completion date
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The date when the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the…
- prisoner
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An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and…
- prisoner advocate
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An IRB member who has a close working knowledge, understanding, and appreciation of conditions from the perspective of prisoners. The prisoner advocate may be a former…