SOCRA CCRP Practice Exam

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Which example does NOT qualify as a SUSAR for drug studies?

Common cold occurrences in a trial for cancer treatment
A single occurrence of a heart attack in a study where the drug is known for such risks
Multiple occurrences of dizziness not commonly associated with the drug
An increase in common disease symptoms treated by the IP

The correct answer is: Common cold occurrences in a trial for cancer treatment

The example of common cold occurrences in a trial for cancer treatment does not qualify as an SUSAR for drug studies because it is not related to the drug being tested. SUSARs, or Suspected Unexpected Serious Adverse Reactions, are adverse events that are both unexpected and serious, and are believed to be caused by the investigational drug. Option A does not meet this criteria because the common cold occurrences are not an unexpected event nor are they related to the drug being tested. Option B, a single occurrence of a heart attack in a study where the drug is known for such risks, may qualify as an SUSAR depending on the severity and expectedness of the event. Option C, multiple occurrences of dizziness not commonly associated with the drug, may also qualify as an SUSAR if there is a significant increase in frequency and severity compared to what is expected for the drug. Option D