CTA Adverse Event Reporting 2

Question 1

Which regulatory agency requires IND safety reports (MedWatch Form FDA 3500A) for serious unexpected adverse drug reactions in the US?

Accepted Answer

FDA

Answer

The FDA requires IND safety reports using MedWatch Form FDA 3500A for serious unexpected adverse drug reactions occurring in US-regulated trials.

Question 2

A subject in a clinical trial experiences a Grade 3 elevation in liver enzymes that resolves without sequelae. How should this be classified?

Accepted Answer

Serious Adverse Event (SAE)

Answer

A Grade 3 laboratory abnormality that requires medical intervention meets the 'medically significant' criterion for classification as a Serious Adverse Event.

Question 3

What is the primary purpose of expedited safety reporting in clinical trials?

Accepted Answer

To allow regulators to assess benefit-risk and protect trial participants promptly

Answer

Expedited reporting enables regulators to rapidly assess the benefit-risk profile of the investigational product and take protective action for trial participants.

Question 4

Under ICH E6(R2), who is ultimately responsible for the timely reporting of SAEs to the sponsor?

Accepted Answer

The Principal Investigator

Answer

ICH E6(R2) places ultimate responsibility on the Principal Investigator to report SAEs to the sponsor immediately or within the timeframe specified by the protocol.

Question 5

A SUSAR must be reported to the FDA within how many calendar days if the event is fatal or life-threatening?

Accepted Answer

7 calendar days

Answer

Fatal or life-threatening unexpected serious adverse reactions (SUSARs) must be reported to the FDA within 7 calendar days of the sponsor first receiving information.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Adverse Event Reporting 2