CPI CPI Adverse Event Management & Reporting 2 — Questions and Answers
Question 1: What does SUSAR stand for in clinical trial safety reporting?
- Serious Unresolved Safety Assessment Report
- Suspected Unexpected Serious Adverse Reaction (Correct answer)
- Summary of Unanticipated Serious Adverse Results
- Subject-Unreported Serious Adverse Response
Correct answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction, the term used in ICH E2A and EMA guidelines for expedited safety reports.
Question 2: Which ICH guideline provides the framework for clinical safety data management and expedited adverse drug reaction reporting?
- ICH E6 (GCP)
- ICH E2A (Correct answer)
- ICH E8
- ICH E10
Correct answer: ICH E2A
ICH E2A defines clinical safety data management, including definitions and standards for expedited reporting of serious adverse drug reactions during clinical development.
Question 3: Under 21 CFR 312.32, within what timeframe must a non-fatal, non-life-threatening unexpected serious adverse drug reaction be reported to the FDA?
- 7 calendar days
- 15 calendar days (Correct answer)
- 30 calendar days
- 60 calendar days
Correct answer: 15 calendar days
Non-fatal, non-life-threatening unexpected serious adverse drug reactions must be reported to the FDA as an IND safety report within 15 calendar days.
Question 4: What is a 'causality assessment' in the context of adverse event reporting?
- A statistical analysis of AE incidence rates across treatment arms
- An evaluation of the likelihood that the study drug caused or contributed to an adverse event (Correct answer)
- A review of the subject's pre-existing conditions prior to enrollment
- An IRB audit of all documented adverse events
Correct answer: An evaluation of the likelihood that the study drug caused or contributed to an adverse event
Causality assessment is the process of evaluating whether a reasonable causal relationship exists between the investigational product and an observed adverse event.
Question 5: Which of the following qualifies as a criterion for classifying an adverse event as 'serious'?
- Grade 2 fatigue lasting more than one week
- Persistent or significant disability or incapacity (Correct answer)
- Any adverse event requiring a dose reduction
- Nausea requiring antiemetic therapy
Correct answer: Persistent or significant disability or incapacity
Persistent or significant disability or incapacity is one of the six FDA-defined criteria that classify an adverse event as serious.
Question 6: What is the primary role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To enroll subjects and collect case report forms
- To independently review accumulating safety data and recommend trial continuation, modification, or stopping (Correct answer)
- To audit the sponsor's financial reporting for the trial
- To submit IND safety reports to the FDA on behalf of the investigator
Correct answer: To independently review accumulating safety data and recommend trial continuation, modification, or stopping
A DSMB is an independent committee that periodically reviews unblinded safety and efficacy data to protect subjects and ensure ongoing trial integrity.
CPI CPI Adverse Event Management & Reporting 2
What does SUSAR stand for in clinical trial safety reporting?