Continuing Review & Adverse Event Reporting Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Continuing Review & Adverse Event Reporting flashcards as text
According to OHRP guidance, an unanticipated problem involving risks to subjects or others must meet which three criteria?
Answer: Unexpected, related or possibly related to participation, and suggesting greater risk than previously known
OHRP's three-part test requires the event to be unexpected, related or possibly related to participation, and to suggest that subjects or others face greater risk than previously recognized.
Under FDA regulations at 21 CFR 312.32, within what timeframe must sponsors report an unexpected fatal or life-threatening serious adverse drug reaction to the IND?
Answer: Within 7 calendar days of initial receipt of information
21 CFR 312.32(c)(2) requires sponsors to notify FDA within 7 calendar days of any unexpected fatal or life-threatening serious adverse drug reaction.
Which of the following best distinguishes a 'protocol deviation' from a 'protocol violation'?
Answer: A deviation is a minor unplanned departure that does not affect safety; a violation affects subject rights, safety, or study integrity
Protocol deviations are minor, unplanned departures with no impact on subject safety or data integrity, while violations are departures that affect subject rights, safety, welfare, or study integrity.
Under 45 CFR 46.103(b)(5), institutions must have written procedures for which of the following?
Answer: Promptly reporting unanticipated problems and serious or continuing noncompliance to OHRP
45 CFR 46.103(b)(5) requires institutions to establish written procedures for ensuring prompt reporting of unanticipated problems and serious or continuing noncompliance to the appropriate parties including OHRP.
What constitutes 'continuing noncompliance' that must be reported to OHRP?
Answer: A pattern of repeated or ongoing failure to comply with regulations or IRB requirements
Continuing noncompliance refers to a pattern of repeated failures or an ongoing failure to adhere to applicable regulations or IRB requirements, not isolated minor deviations.
During continuing review, the IRB must verify that all original criteria for approval remain satisfied. Which criterion specifically addresses the fairness of subject selection?
Answer: Selection of subjects is equitable given the purposes of the research and the population studied
45 CFR 46.111(a)(3) requires the IRB to ensure equitable selection of subjects, considering the purposes of the research and the populations from which subjects will be drawn.
A data breach exposes the identity of subjects enrolled in a stigmatized disease study, creating risk of social harm. Is this reportable as an unanticipated problem?
Answer: Yes, because it is unexpected, related to participation, and poses greater risk of harm to subjects
Unanticipated problems include non-physical harms; a confidentiality breach that exposes subjects to social, psychological, legal, or economic harm qualifies if it meets all three OHRP criteria.