3) based on results of animal experiments, knowledge of natural history of disease
(anticipated results will justify experiment)
4) avoid unnecessary suffering
5) no reason to believe death/disability
6) degree of risk doesn't exceed humanitarian importance
7) proper reparations, adequate facilities
,8) scientifically qualified
9) can withdraw at any time
10) scientist can terminate at any time if believes risk of injury/death
What's the minimum number of IRB members? correct answers 5
In a non-emergency situation, under which of the following conditions, if any, may subjects
be enrolled into a study prior to IRB/IEC approval?
a) the investigator provides written approval
b) the study drug has an FDA approved marketing application
c) the FDA provides written approval of the IND
, d) cannot be enrolled until IRB/IEC approval correct answers cannot be enrolled until
IRB/IEC approval
The responsibility for ensuring that the investigator understands a clinical trial lies with:
correct answers sponsor
A subject has been enrolled on a study and was randomized to the non-treatment arm.
The protocol outlines study procedures for all subjects to be performed within one week
of enrollment. Which is correct:
a) subject doesn't need to undergo procedures since on non-tx arm
b) should undergo all procedures outlined in protocol
c) only needs to undergo procedures pertaining specifically to subject
d) can undergo procedures when convenient correct answers should undergo all study
procedures as outlined in protocol
Significant risk device correct answers An investigational device that
a) is intended as an implant and presents a potential for serious risk to the health, safety
or welfare of the subject
b) is purposed or represented to be for a use in supporting or sustaining human life and presents
a potential serious risk
c) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease
or otherwise preventing impairment of human health.
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