PVC Adverse Drug Reaction Reporting 2 — Questions and Answers
Question 1: Under FDA regulations, what is the expedited reporting timeframe for an unexpected serious adverse drug reaction in a US IND study?
- 7 calendar days
- 15 calendar days (Correct answer)
- 30 calendar days
- 45 calendar days
Correct answer: 15 calendar days
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?
- System Organ Class (SOC)
- High Level Term (HLT)
- Preferred Term (PT) (Correct answer)
- Lowest Level Term (LLT)
Correct answer: Preferred Term (PT)
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?
- The ADR is unrelated because herbs are not drugs
- Causality assessment should consider temporal relationship and plausible mechanism (Correct answer)
- Only the prescribing physician can assess causality
- Causality is irrelevant for herbal product interactions
Correct answer: Causality assessment should consider temporal relationship and plausible mechanism
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?
- Medically significant event
- Life-threatening event
- Serious adverse event under disability criterion (Correct answer)
- Important medical event
Correct answer: Serious adverse event under disability criterion
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?
- Seriousness criteria
- Expectedness field (Correct answer)
- Causality assessment
- Regulatory status
Correct answer: Expectedness field
The expectedness field on the CIOMS I form captures whether the reaction is listed in the current reference safety information (RSI) or product labeling.
Question 6: Which WHO causality category should be applied when an event follows a reasonable temporal sequence and cannot be explained by disease or other drugs, but no rechallenge information is available?
- Certain
- Probable/Likely (Correct answer)
- Possible
- Unlikely
Correct answer: Probable/Likely
The WHO 'Probable/Likely' category applies when a plausible time relationship exists, the event is unlikely attributed to disease or other drugs, and rechallenge data is lacking or unclear.
Question 7: What is the primary purpose of signal detection in pharmacovigilance?
- To confirm that a drug is safe for market approval
- To identify previously unrecognized or incompletely documented safety concerns (Correct answer)
- To replace post-market clinical trials
- To determine product pricing strategies
Correct answer: To identify previously unrecognized or incompletely documented safety concerns
Signal detection aims to identify new or incompletely characterized safety concerns that may require further investigation or risk minimization measures.
PVC Adverse Drug Reaction Reporting 2
Under FDA regulations, what is the expedited reporting timeframe for an unexpected serious adverse drug reaction in a US IND study?