CRP Adverse Event Reporting & Safety Monitoring

Question 1

An adverse event is classified as 'serious' if it meets which criterion?

Accepted Answer

Results in death, is life-threatening, requires hospitalization, or causes persistent disability

Answer

Causes mild discomfort lasting more than 48 hours

Answer

Requires a dose reduction of the investigational product

Answer

Is not anticipated in the study protocol

Question 2

What is the FDA expedited reporting timeframe for a fatal or life-threatening unexpected serious adverse drug reaction under an IND?

Accepted Answer

7 calendar days

Answer

30 calendar days

Answer

15 calendar days

Answer

24 hours

Question 3

Which FDA form is used by sponsors and manufacturers to mandatorily report serious adverse events for marketed drugs?

Accepted Answer

MedWatch Form 3500A (Mandatory Reporting)

Answer

Form FDA 1572 (Statement of Investigator)

Answer

Form FDA 482 (Notice of Inspection)

Answer

Form FDA 1571 (IND Application)

Question 4

What does the acronym SUSAR stand for in clinical research?

Accepted Answer

Suspected Unexpected Serious Adverse Reaction

Answer

Suspected Unrelated Serious Adverse Reaction

Answer

Subject Unanticipated Safety Adverse Report

Answer

Sponsor Unusual Safety Assessment Record

Question 5

In clinical research, an adverse event is considered 'unexpected' when it:

Accepted Answer

Is not listed in or is inconsistent with the risk information in the Investigator's Brochure

Answer

Occurs without the investigator present

Answer

Occurs outside of normal clinic hours

Answer

Is not reported by the participant to the study team

Question 6

Which independent body is primarily responsible for reviewing accumulating unblinded safety data during a clinical trial and can recommend stopping the trial?

Accepted Answer

Data Safety Monitoring Board (DSMB)

Answer

Institutional Review Board (IRB)

Answer

FDA Office of Clinical Trials

Answer

Sponsor's Regulatory Affairs Department

Question 7

Under 21 CFR 312.32, a non-fatal, non-life-threatening unexpected serious adverse drug reaction must be reported to the FDA within:

Accepted Answer

15 calendar days

Answer

7 calendar days

Answer

10 calendar days

Answer

30 calendar days