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

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.

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

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.

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

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.

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

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.

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

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.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Continuing Review & Adverse Event Reporting 2