CRP Adverse Event Reporting & Safety Monitoring 1

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

Under ICH E6 GCP and 21 CFR 312.32, a serious adverse event (SAE) is defined as one resulting in death, a life-threatening situation, inpatient hospitalization, persistent/significant disability, congenital anomaly, or a medically important event.

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

Under 21 CFR 312.32(c)(1)(i), sponsors must notify FDA within 7 calendar days of a fatal or life-threatening unexpected serious adverse drug reaction.

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

MedWatch Form 3500A is the mandatory reporting form used by manufacturers, distributors, and importers to report SAEs associated with marketed drug and biologic products.

Question 4

What does the acronym SUSAR stand for in clinical research?

Accepted Answer

Suspected Unexpected Serious Adverse Reaction

Answer

SUSAR stands for Suspected Unexpected Serious Adverse Reaction, referring to a serious reaction that is both unexpected (not in the IB) and considered related to the investigational product.

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

An unexpected adverse event is one whose nature, severity, or frequency is not consistent with or not listed in the current Investigator's Brochure or protocol risk information.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Adverse Event Reporting & Safety Monitoring 1