CIP Continuing Review & Adverse Event Reporting

Question 1

Under 45 CFR 46.109(e), how often must the IRB conduct continuing review of approved research?

Accepted Answer

At intervals appropriate to the degree of risk, but not less than once per year

Answer

At least once per year regardless of risk level

Answer

At least every six months for all studies

Answer

Every two years for minimal risk research

Question 2

Which of the following best meets the OHRP criteria for a reportable unanticipated problem involving risks to subjects or others?

Accepted Answer

An unexpected serious adverse event that is related or possibly related to participation

Answer

An expected adverse event listed in the consent form and protocol

Answer

A protocol deviation that did not affect subject safety or welfare

Answer

A minor administrative error in consent form documentation

Question 3

Under the 2018 revised Common Rule, continuing review is no longer required for which category of research?

Accepted Answer

Minimal risk research approved under expedited review where interventions are complete

Answer

Research involving greater than minimal risk at an early stage

Answer

Research involving prisoners at any risk level

Answer

Multi-site clinical trials with an independent DSMB

Question 4

What is the primary purpose of IRB continuing review?

Accepted Answer

To ensure ongoing research continues to meet ethical and regulatory standards

Answer

To verify that the research budget is being properly expended

Answer

To update investigators on new IRB membership and procedures

Answer

To collect data for the institution's annual OHRP compliance report

Question 5

An investigator reports a serious adverse event that occurred at another site in a multi-site study. What should the IRB do first?

Accepted Answer

Determine whether the event is related to the research and whether it affects the local protocol

Answer

Immediately suspend the local site's involvement in the study

Answer

Report the event to FDA and OHRP regardless of local relevance

Answer

Notify all locally enrolled subjects immediately by letter

Question 6

If an IRB's approval period expires before continuing review is completed, what must occur?

Accepted Answer

All research activities involving human subjects must stop until renewal is granted

Answer

Research may continue for 30 additional days with approval from the IRB chair

Answer

Data collection may continue but no interventions may be performed

Answer

The PI may request a 60-day administrative extension without formal IRB action

Question 7

Which of the following documents must typically be included in a continuing review submission?

Accepted Answer

Current enrollment numbers, summary of adverse events, and any protocol changes since last review

Answer

Investigator's five-year financial disclosure and tax records

Answer

A new full protocol application identical to the original submission

Answer

Signed letters of support from the funding agency and department chair