PVC Adverse Event Reporting & Case Management 1 — Questions and Answers
Question 1: Which of the following is considered a serious adverse event (SAE)?
- Mild headache lasting a few hours
- Injection site pain
- Hospitalization due to severe allergic reaction (Correct answer)
- Temporary rash with no treatment
Correct answer: Hospitalization due to severe allergic reaction
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes significant disability.
Question 2: What is the minimum required information to consider a valid Individual Case Safety Report (ICSR)?
- Only the patient’s full medical history
- A suspected drug and a lab test result
- Four minimum criteria: reporter, patient, event, drug (Correct answer)
- Just a description of the adverse event
Correct answer: Four minimum criteria: reporter, patient, event, drug
A valid ICSR must include four elements: an identifiable reporter, an identifiable patient, a suspected adverse event, and a suspected drug.
Question 3: Which coding system is primarily used to classify adverse events in pharmacovigilance?
- ICD-10
- SNOMED
- LOINC
- MedDRA (Correct answer)
Correct answer: MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is the standard terminology used globally to code and classify adverse events.
Question 4: Who is responsible for reporting adverse events in post-marketing surveillance?
- Only the manufacturer
- Only healthcare providers
- Only patients
- Healthcare providers, patients, and manufacturers (Correct answer)
Correct answer: Healthcare providers, patients, and manufacturers
Healthcare professionals, patients, and the Marketing Authorization Holder (MAH) all play roles in reporting adverse events after a drug is marketed.
Question 5: What is the appropriate timeline for reporting a fatal adverse drug reaction to regulatory authorities?
- 15 calendar days
- 21 working days
- 30 calendar days
- 7 calendar days (Correct answer)
Correct answer: 7 calendar days
A fatal adverse drug reaction must be reported within 7 calendar days according to international pharmacovigilance guidelines.
Question 6: In a clinical trial setting, who is typically responsible for initial adverse event reporting?
- The FDA
- Clinical trial sponsor
- Trial investigator (Correct answer)
- The patient
Correct answer: Trial investigator
Investigators are responsible for identifying and reporting adverse events to the sponsor during clinical trials.
PVC Adverse Event Reporting & Case Management 1
Which of the following is considered a serious adverse event (SAE)?