Unanticipated device AE should be reported by investigator to sponsor and IRB
within ____ working days of knowledge of effect
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10
, The clinical investigator shall update FDA with any relevant changes that occur during
the course of the study and for _____ year following its completion
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1
IRB determinations for emergency situations are to be retained by IRB for at least ___
years after completion of clinical investigation
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3
Ground for termination : IND remains inactive for ____ years
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5 or more
Serious,unexpected ADRs that are not fatal or life threatening must be filed ASAP but
no later than ____ calendar days after first knowledge by sponsor that case meets
criteria
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within ____ working days of knowledge of effect
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10
, The clinical investigator shall update FDA with any relevant changes that occur during
the course of the study and for _____ year following its completion
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1
IRB determinations for emergency situations are to be retained by IRB for at least ___
years after completion of clinical investigation
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3
Ground for termination : IND remains inactive for ____ years
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5 or more
Serious,unexpected ADRs that are not fatal or life threatening must be filed ASAP but
no later than ____ calendar days after first knowledge by sponsor that case meets
criteria
Give this one a try later!
