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
An IRB may use expedited review procedures for continuing review of approved research when:
Answer: The research involves no more than minimal risk and the work falls within defined expedited categories
Expedited review for continuing review is appropriate when the research involves no more than minimal risk and the activities fit within the federally designated expedited review categories.
When reviewing a continuing review submission, which factor is most important for the IRB to reassess?
Answer: Whether the risk/benefit ratio remains acceptable in light of any new information
A core function of continuing review is to evaluate whether the risk/benefit ratio remains acceptable as new data, adverse events, or other information have emerged since initial approval.
Which of the following actions requires prospective IRB review and approval rather than merely a notification report?
Answer: Making a protocol amendment that increases risk or burden to subjects
Protocol amendments that increase risk or burden to subjects must receive prospective IRB approval before implementation; retrospective events require reporting but not pre-approval.
What did the 'one-year rule' require under the pre-2018 Common Rule?
Answer: Continuing review of approved research was required at least once per year for all studies
Under the pre-2018 Common Rule, all approved research required continuing review at intervals no greater than one year, applying to minimal risk and greater-than-minimal-risk studies alike.
When an investigator discovers a serious unanticipated adverse event, what is the correct sequence of actions?
Answer: Take immediate action to protect subjects → notify the IRB → cooperate with the IRB's evaluation
The investigator's first obligation is to protect subjects from immediate harm, followed by prompt IRB notification so the IRB can evaluate the event and determine required actions.
An IRB determines that noncompliance was serious. Which of the following entities must be notified promptly in writing?
Answer: OHRP and, where applicable, the relevant federal department or agency head supporting or regulating the research
45 CFR 46.103(b)(5) requires prompt written reporting of serious or continuing noncompliance to OHRP and, where applicable, the supporting or regulating federal department or agency head.
Which statement best describes the IRB's authority when continuing review results in a finding of significant new risk to subjects?
Answer: The IRB has authority to suspend or terminate approval of the research to protect subjects
Under 45 CFR 46.113, the IRB has authority to suspend or terminate approval of research that is associated with unexpected serious harm to subjects or is not being conducted in accordance with IRB requirements.