CTA CTA Pharmacovigilance & Drug Safety 1 — Questions and Answers
Question 1: What is pharmacovigilance?
- The process of manufacturing drugs under sterile conditions
- The science and activities related to detection, assessment, understanding, and prevention of adverse effects of medicines (Correct answer)
- The regulatory review of new drug applications
- The statistical analysis of clinical trial data
Correct answer: The science and activities related to detection, assessment, understanding, and prevention of adverse effects of medicines
Pharmacovigilance encompasses the activities designed to detect, assess, understand, and prevent adverse effects or any other drug-related problems throughout the product lifecycle.
Question 2: What is a Serious Adverse Event (SAE) in clinical trials according to ICH E6?
- Any undesirable experience regardless of severity
- An event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly (Correct answer)
- Any event that causes the participant to withdraw from the study
- An event that reduces the drug's effectiveness
Correct answer: An event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly
Per ICH E6, an SAE is any adverse event that results in death, is life-threatening, requires inpatient hospitalization, causes persistent disability, or is a congenital anomaly/birth defect.
Question 3: What differentiates an adverse event (AE) from an adverse drug reaction (ADR)?
- An AE is always serious; an ADR is never serious
- An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship to the drug (Correct answer)
- An ADR only applies to marketed products; an AE only applies to clinical trials
- There is no meaningful difference between an AE and an ADR
Correct answer: An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship to the drug
An AE is any undesirable event regardless of suspected causality to the drug, while an ADR requires that a causal relationship to the drug is at least a reasonable possibility.
Question 4: What is an Investigational New Drug (IND) safety report?
- A report submitted to the IRB before a new protocol is initiated
- A report submitted to the FDA about unexpected serious adverse reactions that may affect participant safety (Correct answer)
- A report submitted to CROs about drug supply issues
- A report documenting protocol deviations during a trial
Correct answer: A report submitted to the FDA about unexpected serious adverse reactions that may affect participant safety
IND safety reports are expedited reports submitted to the FDA when there is a suspected unexpected serious adverse reaction (SUSAR) or new safety information that could affect participant safety or alter the trial conduct.
Question 5: What is the timeframe for reporting a fatal or life-threatening unexpected SUSAR to the FDA under IND regulations?
- 7 calendar days (Correct answer)
- 15 calendar days
- 30 calendar days
- 45 calendar days
Correct answer: 7 calendar days
Under 21 CFR 312.32, fatal or life-threatening unexpected SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial receipt of the information.
Question 6: What does 'unexpected' mean in the context of a Suspected Unexpected Serious Adverse Reaction (SUSAR)?
- The adverse reaction was not anticipated by the investigator
- The adverse reaction is not consistent in nature or severity with the Investigator's Brochure or product labeling (Correct answer)
- The adverse reaction occurred in fewer than 1% of participants
- The adverse reaction was reported at only one study site
Correct answer: The adverse reaction is not consistent in nature or severity with the Investigator's Brochure or product labeling
An adverse reaction is considered unexpected when its nature, severity, or frequency is not consistent with or not listed in the current Investigator's Brochure or approved product labeling.
CTA CTA Pharmacovigilance & Drug Safety 1
What is pharmacovigilance?