SOCRA CCRP Adverse Events 1 — Questions and Answers
Question 1: How is a 'Serious Adverse Event' (SAE) defined under ICH GCP?
- Any adverse event that causes discomfort
- Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes disability (Correct answer)
- An event that causes a protocol deviation
- Any adverse event considered related to the study drug
Correct answer: Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes disability
An SAE is defined as any adverse event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or is a congenital anomaly.
Question 2: What is the difference between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR)?
- There is no difference
- An AE is any untoward event; an ADR implies a causal relationship to the investigational product (Correct answer)
- An ADR is more severe than an AE
- An AE only applies to approved drugs
Correct answer: An AE is any untoward event; an ADR implies a causal relationship to the investigational product
An AE is any untoward occurrence regardless of causality, while an ADR implies at least a reasonable causal relationship to the investigational medicinal product.
Question 3: Under FDA regulations, what is the timeframe for expedited reporting of an unexpected fatal or life-threatening SAE to the FDA?
- 24 hours
- 7 calendar days (Correct answer)
- 15 calendar days
- 30 calendar days
Correct answer: 7 calendar days
Unexpected, fatal or life-threatening SUSARs must be reported to FDA within 7 calendar days per 21 CFR 312.32.
Question 4: What does 'SUSAR' stand for in clinical research?
- Serious Unexpected Study Adverse Reaction
- Suspected Unexpected Serious Adverse Reaction (Correct answer)
- Subject Under Safety Adverse Review
- Sponsor Unreported Safety Adverse Report
Correct answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction that is unexpected and for which there is a reasonable causal relationship to the study drug.
Question 5: Who is primarily responsible for assessing causality of an adverse event to the study drug?
- The data safety monitoring board
- The study sponsor
- The investigator (Correct answer)
- The regulatory authority
Correct answer: The investigator
Under GCP, the investigator is responsible for assessing the causal relationship between an adverse event and the investigational product.
Question 6: What does 'unexpected' mean when describing an adverse event in a clinical trial?
- An event not previously seen in any patient population
- An event not listed or not consistent with the nature or severity described in the Investigator's Brochure (Correct answer)
- An event the investigator was not aware of
- An event that occurs suddenly without warning
Correct answer: An event not listed or not consistent with the nature or severity described in the Investigator's Brochure
'Unexpected' refers to an adverse reaction whose nature, severity, or frequency is not consistent with the information in the Investigator's Brochure or IND.
SOCRA CCRP Adverse Events 1
How is a 'Serious Adverse Event' (SAE) defined under ICH GCP?