CIP Continuing Review & Adverse Event Reporting 2

Question 1

According to OHRP guidance, an unanticipated problem involving risks to subjects or others must meet which three criteria?

Accepted Answer

Unexpected, related or possibly related to participation, and suggesting greater risk than previously known

Answer

Serious, related to funding, and affecting more than one subject

Answer

Expected, severe, and reported within 24 hours of occurrence

Answer

Unexpected, unrelated to the research, and involving physical harm only

Question 2

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?

Accepted Answer

Within 7 calendar days of initial receipt of information

Answer

Within 24 hours of initial receipt of information

Answer

Within 15 calendar days of initial receipt of information

Answer

Within 30 calendar days of initial receipt of information

Question 3

Which of the following best distinguishes a 'protocol deviation' from a 'protocol violation'?

Accepted Answer

A deviation is a minor unplanned departure that does not affect safety; a violation affects subject rights, safety, or study integrity

Answer

A deviation is intentional; a violation is accidental

Answer

A deviation requires IRB report; a violation requires only PI documentation

Answer

A deviation involves FDA-regulated products; a violation involves non-regulated studies

Question 4

Under 45 CFR 46.103(b)(5), institutions must have written procedures for which of the following?

Accepted Answer

Promptly reporting unanticipated problems and serious or continuing noncompliance to OHRP

Answer

Providing annual reports to Congress on research activities

Answer

Conducting quarterly audits of all active protocols

Answer

Publishing adverse event summaries in peer-reviewed journals

Question 5

What constitutes 'continuing noncompliance' that must be reported to OHRP?

Accepted Answer

A pattern of repeated or ongoing failure to comply with regulations or IRB requirements

Answer

A single protocol deviation that did not harm any subject

Answer

A one-time failure to obtain a witness signature on a consent form

Answer

An adverse event that was not anticipated in the original protocol

Question 6

During continuing review, the IRB must verify that all original criteria for approval remain satisfied. Which criterion specifically addresses the fairness of subject selection?

Accepted Answer

Selection of subjects is equitable given the purposes of the research and the population studied

Answer

Risks to subjects are minimized through sound research design

Answer

Adequate provisions exist to protect the privacy of subjects

Answer

The research plan makes adequate provisions for monitoring subject safety

Question 7

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?

Accepted Answer

Yes, because it is unexpected, related to participation, and poses greater risk of harm to subjects

Answer

No, because no physical injury occurred

Answer

No, because data breaches are regulated only by HIPAA, not the Common Rule

Answer

Yes, but only if more than five subjects are affected