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CRC QUESTIONS WITH ANSWERS.
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CRC QUESTIONS WITH ANSWERS.
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CRC QUESTIONS WITH ANSWERS.is the process of studying human subjects to assess the effect of a particular intervention (drug, biologic,
device, procedure, or behavioral change) on a pre-specified set of measurable events (sometimes
referred to as endpoints or outcomes) ANS - Clinical Trials
help establish that the observed outcome is real and not a result of chance, confounding factors, or bias
ANS - Controls
Inclusion and exclusion criteria to prospectively identify appropriate target subject populations
Randomization to avoid selection bias
Blinding to avoid observation bias
Designating primary and secondary endpoints to prove or disprove the study's hypothesis ANS -
Controls
If a molecule shows promise in the laboratory and in animal experiments and is ready to be tested in
humans, the FDA must be notified in advance by submitting what? ANS - IND
These, for example, tongue depressors and adhesive bandages, are usually exempt from premarket
review and do not require clinical trial data before being commercialized. ANS - Low risk or non-
significant risk devices
the FDA's process to evaluate the safety and effectiveness of devices that support or sustain human life,
are of substantial importance in preventing impairment of human health, or which present a potential,
unreasonable risk of illness or injury. ANS - Premarket review
Studies with nonsignificant risk devices must be approved by ANS - IRB
high-risk medical device (also known as a significant risk device), needs what submitted to who for
approval before human subject trials can start? ANS - IDE to FDA and need IRB approval
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