PVC Adverse Drug Reaction Reporting 2

Question 1

Under FDA regulations, what is the expedited reporting timeframe for an unexpected serious adverse drug reaction in a US IND study?

Accepted Answer

15 calendar days

Answer

Unexpected serious adverse drug reactions must be reported to the FDA within 15 calendar days of the sponsor's initial receipt of information under 21 CFR 312.32.

Question 2

Which MedDRA level is used to code adverse events for regulatory submissions?

Accepted Answer

Preferred Term (PT)

Answer

Preferred Terms (PTs) are the primary level used to code adverse events in regulatory submissions and safety databases.

Question 3

A patient taking warfarin experiences unexpected bruising after starting a new herbal supplement. How should causality be assessed?

Accepted Answer

Causality assessment should consider temporal relationship and plausible mechanism

Answer

Causality assessment always considers temporal relationship, biological plausibility, and dechallenge/rechallenge data regardless of whether the suspect product is a drug or supplement.

Question 4

What term describes an adverse event that results in persistent or significant disability or incapacity?

Accepted Answer

Serious adverse event under disability criterion

Answer

Persistent or significant disability or incapacity is one of the six seriousness criteria defined in ICH E2A that classifies an adverse event as serious.

Question 5

In CIOMS I form reporting, which field captures whether the adverse event was previously known in the product labeling?

Accepted Answer

Expectedness field

Answer

The expectedness field on the CIOMS I form captures whether the reaction is listed in the current reference safety information (RSI) or product labeling.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Adverse Drug Reaction Reporting 2