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
Under 45 CFR 46.109(e), how often must the IRB conduct continuing review of approved research?
Answer: At intervals appropriate to the degree of risk, but not less than once per year
45 CFR 46.109(e) requires continuing review at intervals appropriate to the degree of risk, with the maximum interval being one year.
Which of the following best meets the OHRP criteria for a reportable unanticipated problem involving risks to subjects or others?
Answer: An unexpected serious adverse event that is related or possibly related to participation
OHRP defines an unanticipated problem as unexpected, related or possibly related to participation, and suggesting greater risk than previously known.
Under the 2018 revised Common Rule, continuing review is no longer required for which category of research?
Answer: Minimal risk research approved under expedited review where interventions are complete
The 2018 Common Rule eliminated mandatory continuing review for minimal risk research previously approved under expedited review once interventions have been completed.
What is the primary purpose of IRB continuing review?
Answer: To ensure ongoing research continues to meet ethical and regulatory standards
Continuing review ensures that as a study progresses and new information emerges, it continues to satisfy all criteria for IRB approval.
An investigator reports a serious adverse event that occurred at another site in a multi-site study. What should the IRB do first?
Answer: Determine whether the event is related to the research and whether it affects the local protocol
The IRB must first assess relatedness and local impact before deciding on any action such as suspension, protocol modification, or subject notification.
If an IRB's approval period expires before continuing review is completed, what must occur?
Answer: All research activities involving human subjects must stop until renewal is granted
Lapse of IRB approval means the research is no longer approved; all human subjects activities must cease until the IRB completes its review and grants renewal.
Which of the following documents must typically be included in a continuing review submission?
Answer: Current enrollment numbers, summary of adverse events, and any protocol changes since last review
Continuing review submissions must give the IRB current enrollment data, a summary of adverse events and unanticipated problems, and any changes made since the last approval.